Best CH-REP (Swiss Authorized Rep) | Compare & Get Quotes
Compare Swiss Authorized Representative (CH-REP) providers for medical devices. Find CH REP services, SwissMedic representative support, and Switzerland CH REP services. Request quotes from Pro providers.
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Compare Best CH-REP (Swiss Authorized Rep) | Compare & Get Quotes Providers
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Emergo by UL
Emergo by UL offers comprehensive regulatory consulting and human factors expertise for global medical device market access. They specialize in IVDR compliance, device registration, and privacy/security consulting.
Emergo by UL provides specialized regulatory consulting services to help medical device and IVD companies navigate global market access. Their expertise spans across critical areas such as IVDR compliance, device registration in various countries, and post-market surveillance. They also offer in-depth human factors research and design, privacy and security consulting to ensure adherence to regulations like HIPAA and GDPR, and software solutions to streamline regulatory affairs and quality assurance activities. With a focus on the evolving healthcare industry, Emergo by UL leverages its global team and digital tools to simplify and automate RA/QA processes. Their services are designed to support manufacturers throughout the entire product lifecycle, from initial design and development to market entry and ongoing compliance. They are a valuable partner for companies seeking to ensure their medical devices meet international regulatory standards and reach their target markets efficiently.
Website:
emergobyul.com
HQ:
Zurich, USA
Jurisdictions:
CH
Countries:
CH
Languages:
English, German, French
Response SLA:
24 hours
Onboarding time:
1–5 days
Pricing model:
Retainer
Starting from:
CHF 3,500
Services:
Local Contact
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Obelis
Obelis is your trusted partner for global regulatory compliance, specializing in market access for Medical Devices, Cosmetics, Toys, Food Supplements, and Motor Vehicles across the EU, UK, US, and Switzerland.
Obelis Group is a leading regulatory compliance specialist, dedicated to accelerating your market access worldwide. With extensive experience in the EU, UK, US, and Switzerland, Obelis provides expert guidance and comprehensive services for a wide range of industries, including Medical Devices, Cosmetics, Toys, Food Supplements, and Motor Vehicles. We act as your Authorised Representative and Responsible Person, ensuring your products meet all local regulatory requirements. Our services encompass formula review, labelling compliance, claims verification, product registration, technical documentation management, and communication with regulatory authorities. Whether you are navigating the complexities of the EU General Product Safety Regulation (GPSR) or ensuring your toys meet stringent safety standards, Obelis offers tailored solutions. Obelis also provides specialized training programs to help your team master EU compliance requirements for cosmetics and medical devices. Our flexible training options, including in-house, online, and on-demand modules, empower your staff with the knowledge and tools needed for successful market entry and sustained compliance. Partner with Obelis to confidently bring your products to international markets while mitigating risks and building consumer trust.
Website:
obelis.ch
HQ:
Brussels, BE
Jurisdictions:
CH
Countries:
CH
Languages:
English, German, French
Response SLA:
24 hours
Onboarding time:
1–5 days
Pricing model:
Retainer
Starting from:
CHF 3,500
Device Classes:
Class I, IVD
Services:
Labeling, Local Contact, Vigilance
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MDSS
MDSS is a trusted Authorized Representative and Regulatory Affairs specialist for Medical and In Vitro Diagnostic Devices, with over 30 years of experience serving clients globally.
MDSS has been a leading Authorized Representative and Regulatory Affairs specialist for Medical and In Vitro Diagnostic Devices for over 30 years. They offer comprehensive In-Country Representation services across the EU, United Kingdom, Switzerland, USA, and Australia, acting as European Authorized Representative, UK Responsible Person, Swiss Authorized Representative, U.S. Agent & Australian TGA Sponsor. This allows non-EU based companies to place their devices on these markets while focusing on innovation. Specifically for the Swiss market, MDSS acts as the Swiss Authorized Representative (CH-REP), a requirement for manufacturers located outside Switzerland to place their devices according to the MedDO and IvDO regulations. MDSS guides clients through regulatory requirements with Swissmedic and Swissdamed registration, serving as the primary contact for Swiss authorities regarding formal and safety-related issues. MDSS also assists with compliance for new regulations such as the AI ACT and GPSR, appointing them as your EU Representative to meet these mandates. They are committed to helping manufacturers navigate complex regulatory landscapes and ensure compliance with evolving standards.
Website:
mdss.com
HQ:
Aarau, DE
Jurisdictions:
CH
Countries:
CH
Languages:
English, German, French
Response SLA:
24 hours
Onboarding time:
1–5 days
Pricing model:
Retainer
Starting from:
CHF 3,500
Device Classes:
Class I, IVD
Services:
Local Contact, Vigilance, Named on Label
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MedEnvoy
MedEnvoy provides expert In-Country Representation and Regulatory Importer services for medical devices, IVDs, and cosmetics in European markets
MedEnvoy simplifies bringing medical devices, IVDs, and cosmetics to market by overcoming complex regulations. They serve as a leading In-Country Representative and Regulatory Importer for European markets, including Switzerland, the EU, and the UK
Website:
medenvoyglobal.com
HQ:
Basel, Switzerland
Jurisdictions:
CH
Countries:
CH
Languages:
English, German, French
Response SLA:
24 hours
Onboarding time:
1–5 days
Pricing model:
Onboarding + annual retainer
Starting from:
CHF 2,500
Device Classes:
IVD
Services:
Local Contact, Vigilance, Named on Label
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OMC Medical (CHREP)
OMC Medical is your trusted Swiss Authorized Representative (CH-REP) partner, ensuring seamless regulatory compliance and market access for medical devices, IVDs, cosmetics, and pharmaceuticals in Switzerland.
OMC Medical specializes in assisting medical device manufacturers in navigating Switzerland’s complex regulatory framework. As your dedicated Swiss Authorized Representative (CH-REP), they ensure seamless compliance and market access for your products, covering medical devices, in vitro diagnostics (IVDs), cosmetics, and pharmaceuticals. Their expertise spans product registration, technical documentation, local representation, quality assurance, clinical evaluation, and post-market surveillance, ensuring your products meet Swissmedic and MedDO/IvDO requirements. They act as the official liaison between Swissmedic and manufacturers, maintaining access to technical files for audits and monitoring product performance. OMC Medical offers tailored solutions to help you achieve compliance and successfully enter the Swiss medical device, IVD, cosmetic, and pharmaceutical markets, ensuring a smooth and hassle-free market entry. With a proven track record, OMC Medical is a trusted partner for global manufacturers seeking regulatory excellence and seamless market access in Switzerland. They provide end-to-end compliance support, from initial registration to ongoing vigilance reporting, ensuring your products meet all safety, quality, and compliance standards.
Website:
chrep.omcmedical.com
HQ:
London, Switzerland
Jurisdictions:
CH
Countries:
CH
Languages:
English, German, French
Response SLA:
24 hours
Onboarding time:
1–5 days
Pricing model:
Onboarding + annual retainer
Starting from:
CHF 2,500
Device Classes:
IVD
Services:
Labeling, Local Contact, Vigilance
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Decomplix
Decomplix, powered by Taylor & Francis, offers specialized digital hubs for medical and scientific professionals, providing access to journals, research, and community forums.
Decomplix, operating under the umbrella of Taylor & Francis Group, is a provider of specialized digital platforms designed for medical and scientific professionals. These platforms, such as Medical Devices Zone and Bioanalysis Zone, serve as comprehensive resources for accessing the latest research, news, and discussions within specific fields. They feature a wealth of content including journal articles, eBooks, webinars, expert commentaries, and community forums, fostering collaboration and knowledge sharing. Taylor & Francis, a leading academic publisher with over two centuries of experience, is committed to making high-quality research accessible globally. With a presence in 14 countries and a vast portfolio of over 180,000 book titles and 2,700 journals, they support a diverse community of experts, researchers, and knowledge makers. Their purpose is to foster human progress through knowledge, ensuring that trusted information accelerates and maximizes the impact of scholarly work.
Website:
decomplix.com
HQ:
London, UK
Jurisdictions:
CH
Countries:
CH
Languages:
English, German, French
Response SLA:
48 hours
Onboarding time:
3–10 days
Pricing model:
Custom pricing
Starting from:
CHF 1,500
Device Classes:
Class I, Class IIa, Class IIb
Services:
Labeling, Local Contact, Vigilance
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Freyr (CH-Rep Services)
Freyr (CH-Rep Services) provides expert Swiss Authorized Representative (CH-REP) services for medical device manufacturers seeking to market their products in Switzerland. They offer regulatory support, liaise with Swissmedic, and ensure compliance with Swiss regulations.
Freyr (CH-Rep Services) is a specialized provider of Swiss Authorized Representative (CH-REP) services, essential for medical device manufacturers looking to access the Swiss market. They offer comprehensive regulatory support, including appointing a CH-REP, representing devices in Switzerland, and liaising directly with Swissmedic on your behalf. Their services ensure your medical devices meet all necessary compliance requirements for registration and marketing. With a strong understanding of Swissmedic's regulations, including recent amendments to the Medical Devices Ordinance (MedDO), Freyr helps navigate the complexities of market access. They provide guidance on unique identification numbers (CHRN), reporting of incidents and field safety corrective actions (FSCA), and clinical trial requirements. Freyr's expertise extends to reviewing technical files for compliance and ensuring your labeling meets Swiss standards. Freyr offers a free 30-minute consultation to discuss your specific needs and provides step-by-step guidance throughout the process. Their commitment is to facilitate a smooth and compliant entry into the Swiss market for your medical and in-vitro devices.
Website:
ch-repservices.com
HQ:
Princeton, USA
Jurisdictions:
CH
Countries:
CH
Languages:
English, German, French
Response SLA:
24 hours
Onboarding time:
1–5 days
Pricing model:
Retainer
Starting from:
CHF 3,500
Device Classes:
Class I, Class IIa, Class IIb
Services:
Labeling, Local Contact, Vigilance
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QbD Group
QbD Group is a strategic partner in Life Sciences, accelerating innovation and ensuring confident growth through regulatory compliance and operational excellence. They offer full-life cycle support for pharma, MedTech, and IVD companies.
QbD Group is a strategic partner in Life Sciences, dedicated to accelerating innovation from idea to patient and ensuring confident growth through regulatory compliance and operational excellence. With over 600 professionals, they provide full-life cycle support for start-ups, scale-ups, and global leaders in pharma, MedTech, and IVD. Their services encompass a wide range of expertise, including Regulatory Affairs, Quality Assurance, Lab Services, Qualification & Validation, Vigilance, Clinical Solutions, Software Solutions, and Toxicology. They specialize in helping global Pharma and MedTech companies enter and thrive in Europe, offering deep GxP know-how, regulatory strategy, clinical evidence, and importation expertise. QbD Group prides itself on delivering tailored, cost-effective solutions with lean project setups and solid project management. Their hands-on teams take ownership, solve problems proactively, and deliver high-quality results efficiently and effectively, embedding into client teams with flexibility and transparency to drive shared success and build long-term partnerships.
Website:
qbdgroup.com
HQ:
Antwerp, BE
Jurisdictions:
CH
Countries:
CH
Languages:
English, German, French
Response SLA:
24 hours
Onboarding time:
1–5 days
Pricing model:
Retainer
Starting from:
CHF 3,500
Device Classes:
IVD
Services:
Vigilance
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Qarad Suisse S.A.
Qarad is a specialized consulting firm for the IVD and Medical Device industry, offering expertise in Regulatory Affairs and Quality Systems. They are part of the QbD Group, providing comprehensive product lifecycle support.
Qarad is a consulting company with over 30 years of experience, specializing in Regulatory Affairs and Quality Systems for the In Vitro Diagnostics (IVD) and Medical Device (MD) industries. They offer a comprehensive suite of services including CE Marking, Quality Systems, Risk Management, and e-Labeling (eIFU) solutions, leveraging new technologies to simplify processes for their clients. As an ISO 13485:2016 and ISO 27001:2022 certified company, Qarad ensures high standards in quality management and information security. Their services cover the sales and provision of consulting, training, authorized representative functions, performance evaluation, and e-labeling for the medical device sector. Qarad is a proud member of the QbD Group, a multinational organization with over 600 employees that supports life science companies globally throughout the entire product lifecycle, from initial idea to patient. This affiliation allows Qarad to offer extended services in regulatory affairs, clinical trials, qualification & validation, quality assurance, lab services, software solutions, and business communications, backed by a global network of expertise.
Website:
qarad.com
HQ:
Lausanne, CH
Jurisdictions:
CH
Countries:
CH
Languages:
English, German, French
Response SLA:
24 hours
Onboarding time:
1–5 days
Pricing model:
Onboarding + annual retainer
Starting from:
CHF 2,500
Device Classes:
Class I, Class IIa, Class IIb
Swiss Establishment:
Zug
Services:
Labeling, Local Contact, Vigilance
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Thema Med
Thema Med is a leading regulatory consultancy specializing in Medical Devices and IVDs. They offer strategic guidance and support for market access and compliance in Italy, Europe, and internationally.
Thema Med provides expert strategic regulatory consulting services for companies manufacturing or distributing Medical Devices (MD) and In Vitro Diagnostic Medical Devices (IVD) in both national and international markets. Their primary goal is to partner with clients, offering reliable and competent regulatory support to help them achieve their sales objectives. The company focuses on navigating the complex regulatory landscape, including MDR (EU) 2017/745 updates and the implications of Brexit for Swiss market access. They offer comprehensive support for CE marking, Italian and European ministerial registrations, and international registrations outside the EU. Additionally, Thema Med provides services for Local Representation, Quality and GMP compliance, and training and events. With a mission to save lives and preserve health, Thema Med is dedicated to enabling clients to bring safe, effective, and high-quality products to market. They aim to be a key part of a system that promotes information and training in the medical field, ensuring access to adequate treatments and products worldwide.
Website:
thema-med.com
HQ:
Imola, IT
Jurisdictions:
CH
Countries:
CH
Languages:
English, German, French
Response SLA:
24 hours
Onboarding time:
1–5 days
Pricing model:
Onboarding + annual retainer
Starting from:
CHF 2,500
Device Classes:
Class I, Class IIa, Class IIb
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Casus Consulting
Casus Consulting is a specialized consultancy assisting companies with regulatory compliance for medical devices and IVDs in Europe, the UK, and Switzerland. They offer expertise in EU Authorized Representation, UK Responsible Person services, and Swiss Authorized Representation.
Casus Consulting provides expert guidance for navigating the complex regulatory landscapes of Europe, the United Kingdom, and Switzerland for medical devices and in vitro diagnostic devices (IVDs). Their services include acting as an EU Authorized Representative, fulfilling the role of a UK Responsible Person for MHRA device registration and UKCA marking, and serving as a Swiss Authorized Representative for Swissmedic device registration. With a focus on market access, Casus Consulting helps manufacturers understand and comply with regulations such as the MDR CE Marking and IVDR CE Marking in the EU, and the specific requirements for the UK and Switzerland. They are adept at managing the 'Steps to Market' in these key regions. Recent updates highlight their knowledge of the Swiss regulatory framework, including the alignment of Swissmedic's Manufacturer Incident Report (MIR) form with EU standards, demonstrating their commitment to keeping clients informed of evolving requirements.
Website:
casusconsulting.com
HQ:
Boston, Switzerland
Jurisdictions:
CH
Countries:
CH
Languages:
English, German, French
Response SLA:
48 hours
Onboarding time:
3–10 days
Pricing model:
Custom pricing
Starting from:
CHF 1,500
Device Classes:
IVD
Services:
Local Contact, Vigilance, Named on Label
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CMC Medical Devices
CMC Medical Devices offers expert regulatory consulting and in-country representation for medical devices. They specialize in navigating global markets, ensuring compliance and facilitating market access for manufacturers.
CMC Medical Devices is a global regulatory consulting firm specializing in medical devices and in vitro diagnostics. With a strong presence in Spain and offices across the UK, Switzerland, China, Australia, and the USA, they provide personalized services to help manufacturers achieve regulatory compliance and market access in any country. Their services include in-country representation, acting as the primary point of contact with local authorities, and facilitating smooth communication. They also offer comprehensive consulting services, including assistance with Free Sale Certificates, acting as a Contract Research Organization (CRO) to accelerate product approvals, and establishing Quality Management Systems according to ISO 13485:2016. CMC Medical Devices is particularly adept at navigating complex regulatory landscapes, such as the Swissmedic requirements for systems and procedure packs, and the implementation of EU regulations in Switzerland. They specialize in acting as your representative in key negotiations and managing strategic relationships with stakeholders to facilitate business expansion.
Website:
cmcmedicaldevices.com
HQ:
Malaga, Spain
Jurisdictions:
CH
Countries:
CH
Languages:
English, German, French
Response SLA:
24 hours
Onboarding time:
1–5 days
Pricing model:
Onboarding + annual retainer
Starting from:
CHF 2,500
Services:
Labeling, Local Contact, Vigilance
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Metecon Switzerland GmbH
Metecon Switzerland GmbH offers expert regulatory compliance services, specializing in EU and Swiss Authorized Representative (EC-REP & CH-REP) functions for medical devices and IVDs.
Metecon Switzerland GmbH is a specialized consultancy focused on providing comprehensive regulatory compliance solutions for medical devices and in-vitro diagnostics (IVDs). They offer crucial services as an EU Authorized Representative (EC-REP) to facilitate market access within the European Union and as a Swiss Authorized Representative (CH-REP) for the Swiss market. Their expertise covers navigating complex regulations such as MDR, IVDR, MepV, and IvDV, ensuring that manufacturers meet all necessary requirements for product registration and compliance. Metecon aims to simplify the compliance journey for their clients, offering a 360° approach to regulatory affairs. With a strong emphasis on both European and Swiss market access, Metecon Switzerland GmbH positions itself as a reliable partner for companies seeking to successfully launch and maintain their products in these key regions. They provide guidance and support throughout the entire compliance lifecycle.
Website:
metecon.ch
HQ:
Bern, CH
Jurisdictions:
CH
Countries:
CH
Languages:
English, German, French
Response SLA:
24 hours
Onboarding time:
1–5 days
Pricing model:
Onboarding + annual retainer
Starting from:
CHF 2,500
Device Classes:
IVD
Services:
Local Contact, Named on Label
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SMQS GmbH
VDE is a leading European technology organization focused on innovation, standardization, testing, and certification in electrical, electronic, and information technologies. They advance technology and support the next generation of engineers.
VDE, one of Europe's largest technology organizations, has been a driving force for innovation and technological progress for over 130 years. Uniquely, VDE integrates science, standardization, testing, certification, and application consulting under one roof. The VDE mark signifies the highest safety standards and consumer protection for a century. Dedicated to advancing technology, nurturing future engineers, and promoting lifelong learning, VDE operates globally with 2,000 employees across more than 60 locations. Their network includes over 100,000 honorary experts and 1,500 companies committed to creating a sustainable future. VDE's activities span crucial areas such as AI & Digital Trust, Energy, Health, Mobility, Next Generation, and Standardization. The VDE Publishing House offers electrotechnical safety standards and books, with special discounts for VDE members. They also independently and neutrally test and certify electrotechnical devices, components, and systems worldwide. VDE recognizes scientific commitment through various prizes and awards, honoring both emerging talent and established scientists.
Website:
smqs.ch
HQ:
Offenbach am Main, DE
Jurisdictions:
CH
Countries:
CH
Languages:
English, German, French
Response SLA:
48 hours
Onboarding time:
3–10 days
Pricing model:
Custom pricing
Starting from:
CHF 1,500
Device Classes:
Class I, Class IIa, Class IIb
Swiss Establishment:
Zug
Services:
Labeling, Local Contact, Vigilance
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TS Quality
TeamSpeak offers crystal-clear, lag-free voice communication with military-grade security and unparalleled reliability. It provides users with complete control over their communication experience, focusing on privacy and advanced features.
TeamSpeak is a leading provider of voice communication solutions, renowned for its crystal-clear sound quality, lag-free performance, and military-grade security. Designed for teams and communities, it offers unparalleled reliability and uptime, ensuring seamless communication across platforms. A key differentiator for TeamSpeak is its commitment to user control and privacy; unlike other solutions, it does not rely on centralized servers, does not harvest user data for sale, and empowers users to dictate how their communication environment functions. The platform boasts advanced features such as automatic microphone volume adjustment, background noise reduction, and echo cancellation for an optimal audio experience. Users benefit from secure global messaging, simple cross-device setup, and access to over 100 add-ons, skins, and voice packs. TeamSpeak is dedicated to providing a secure, private, and highly customizable communication environment, making it the preferred choice for gamers, businesses, and organizations seeking robust and reliable voice services.
Website:
tsquality.ch
HQ:
Lausanne, US
Jurisdictions:
CH
Countries:
CH
Languages:
English, German, French
Response SLA:
48 hours
Onboarding time:
3–10 days
Pricing model:
Custom pricing
Starting from:
CHF 1,500
Device Classes:
IVD
Services:
Local Contact
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MDQ Services Ltd
LC Services Ltd is a UK-based independent provider of chromatography analytical services and parts. With 30 years of expertise, they offer maintenance, servicing, troubleshooting, and a wide range of parts for laboratory equipment, including HPLC and GC systems.
LC Services Ltd, established in 1996 and with roots tracing back to 1989, is a leading independent provider of chromatography analytical services and parts in the UK. Strategically located in Turvey, Bedfordshire, they leverage 30 years of experience to offer comprehensive support for laboratory chromatography systems. Their services include tailored maintenance plans with a 48-hour response time, troubleshooting, and preventative maintenance for all analytical instrumentation. They specialize in supporting HPLC, GC, Mass Spectrometry, LCMS, GCMS, ICP, and ICPMS systems. LC Services Ltd also provides a wide selection of new and refurbished parts and consumables, including an exchange program for faulty parts to help reduce equipment costs. Their commitment to quality is assured by in-house engineers, and they offer worldwide delivery and global distributors for their parts supply. The company prides itself on its knowledgeable and fully trained analytical engineers and support team, who are available to advise and assist with any enquiry. They operate in accordance with UK Data Protection Act 2018 and GDPR, ensuring the privacy and security of user data.
Website:
mdqservices.co.uk
HQ:
Turvey, United Kingdom
Jurisdictions:
CH
Countries:
CH
Languages:
English, German, French
Response SLA:
48 hours
Onboarding time:
3–10 days
Pricing model:
Custom pricing
Starting from:
CHF 1,500
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Arazy Group
Arazy Group is a leading regulatory affairs consulting firm specializing in medical device and IVD product registration. They offer AI-powered solutions and expert guidance to accelerate market access in over 140 countries.
Arazy Group is a premier consulting firm with over 30 years of experience, dedicated to streamlining regulatory affairs and product registration for medical devices and IVDs. Their mission is to facilitate the global availability of innovative medical technologies. Leveraging cutting-edge AI-powered technology and deep regulatory expertise, Arazy Group provides solutions that expedite device registration in over 140 countries. Their platform offers customized submission files, automated compliance workflows, and real-time process management, significantly reducing time-to-market and associated risks. They offer comprehensive services including global authorized representative and license holder services, ensuring compliance and market access across diverse regions. Arazy Group's commitment to client success is demonstrated through personalized support and a focus on building long-term partnerships, making them a trusted advisor for companies ranging from startups to multinational corporations.
Website:
arazygroup.com
HQ:
Vancouver, Canada
Jurisdictions:
CH
Countries:
CH
Languages:
English, German, French
Response SLA:
24 hours
Onboarding time:
1–5 days
Pricing model:
Onboarding + annual retainer
Starting from:
CHF 2,500
Device Classes:
Class I, Class IIa, Class IIb
Services:
Local Contact, Named on Label
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Epmodex
Sweazy GmbH offers innovative point-of-care technology solutions, focusing on digital platforms for medical cannabis and health projects. They connect investors and clients through their services.
Sweazy GmbH is a Swiss company specializing in point-of-care technology and innovative solutions. They provide a secure digital platform for medical cannabis in Switzerland, emphasizing the importance of terpene profiles in therapy. The company also engages in health projects, connecting investors and venture capitalists with opportunities. Their services extend to facilitating online appointment bookings and showcasing their client portfolio. Sweazy GmbH is registered in the commercial register of the Canton of Zug, underscoring their established presence in the Swiss market.
Website:
epmodex.com
HQ:
Baar, CH
Jurisdictions:
CH
Countries:
CH
Languages:
English, German, French
Response SLA:
48 hours
Onboarding time:
3–10 days
Pricing model:
Custom pricing
Starting from:
CHF 1,500
Device Classes:
Class I, Class IIa, Class IIb
Swiss Establishment:
Zug
Services:
Labeling, Local Contact, Vigilance
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confinis
Confinis is a global consulting firm specializing in regulatory affairs, compliance, and strategic market access for medical devices, diagnostics, and combination products. They offer expert guidance to streamline submissions, ensure compliance, and accelerate approvals.
Confinis is a global consulting firm with expertise in medical devices, in vitro diagnostics, and combination products, based in Switzerland and the USA. They specialize in helping clients navigate complex regulatory landscapes to achieve market authorization and ensure compliance. Their services encompass a wide range of regulatory affairs, including strategy development, market authorization requirements, and representation services (CH REP, UK REP, US AGENT to the FDA). Confinis also provides comprehensive compliance support, covering areas such as MDR Article 117, IVDR conformity, design control, risk management, usability engineering, and clinical evaluation. They assist with CE marking, FDA registrations, and performance evaluations. Beyond basic compliance, Confinis offers services to optimize operational excellence and strategic success. This includes product development strategies, market entry planning, and tailored support for startups and SMEs. They also provide e-learning and training programs through the confinis Academy, covering topics like ISO 13485, EUDAMED, AI in medical devices, and cybersecurity. With a focus on pragmatic and workable solutions, Confinis leverages its practical experience and theoretical foundations to act as a trusted partner for clients seeking to streamline regulatory submissions, ensure product safety and efficacy, and accelerate time-to-market.
Website:
confinis.com
HQ:
Düdingen, Switzerland
Jurisdictions:
CH
Countries:
CH
Languages:
English, German, French
Response SLA:
24 hours
Onboarding time:
1–5 days
Pricing model:
Onboarding + annual retainer
Starting from:
CHF 2,500
Services:
Labeling, Local Contact, Vigilance
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Effectum CH-REP
Effectum CH-REP AG is your dedicated Swiss Authorized Representative, ensuring seamless market access for medical devices in Switzerland. We provide expert regulatory compliance and support.
Effectum CH-REP AG serves as your essential Swiss Authorized Representative, crucial for manufacturers outside Switzerland seeking to access the Swiss market. With the Medical Device Ordinance (MedDO) and In-Vitro Diagnostic Regulation (IvDV) fully in effect, appointing a Swiss Representative is mandatory. Our team comprises senior experts with extensive MedTech knowledge, offering specialized services including product registration, compliance with Swiss registration requirements, and collaboration with Swissmedic for audits and product sample requests. We also provide a designated Person Responsible for Regulatory Compliance (PRRC) and guarantee access to technical documentation. We streamline the process of becoming compliant, ensuring your products meet all necessary Swiss regulatory standards. Our goal is to facilitate your market entry and ongoing compliance with efficiency and expertise.
Website:
effectum-chrep.com
HQ:
Olten, CH
Jurisdictions:
CH
Countries:
CH
Languages:
English, German, French
Response SLA:
48 hours
Onboarding time:
3–10 days
Pricing model:
Custom pricing
Starting from:
CHF 1,500
Device Classes:
Class I, Class IIa, Class IIb
Services:
Labeling, Local Contact, Vigilance
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CH-REP.com
CH-REP.com provides specialized services for foreign medical device manufacturers and Swiss importers/distributors, acting as an Authorised Representative in Switzerland.
CH-REP.com offers tailored, product-specific services for foreign manufacturers and for importers and distributors in Switzerland. Since May 26, 2021, Switzerland is considered a third country to the EU, meaning mutual recognition of conformity assessment procedures no longer applies. Consequently, foreign manufacturers of medical devices must appoint a 'Swiss Authorised Representative'. CH-REP.com is available to serve as this representative for manufacturers outside of Switzerland. For Swiss importers and distributors of medical devices and in-vitro diagnostic devices, CH-REP.com provides competent and uncomplicated support to help them fulfill their obligations according to (EU) 2017/745 (Medical Device Regulation) and (EU) 2017/746 (IVDR).
Website:
ch-rep.com
HQ:
Münsingen, CH
Jurisdictions:
CH
Countries:
CH
Languages:
English, German, French
Response SLA:
24 hours
Onboarding time:
2–7 days
Pricing model:
Onboarding + annual retainer
Starting from:
CHF 2,000
Device Classes:
Class I, Class IIa, Class IIb
Services:
Local Contact, Vigilance, Named on Label
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Élite Med Group
Elite Medical Group offers comprehensive healthcare for all ages in Tupelo, MS. They provide preventive care, treatment for acute and chronic issues, and specialized services like women's health and lab work.
Baptist Medical Group-Elite Medical Clinic is your source for comprehensive, quality health care for patients of all ages in Tupelo, Mississippi. They offer both preventive care and treatment for acute and chronic medical issues, ensuring all your wellness and prevention needs are met. Their dedicated providers have decades of experience delivering quality care. Services include pediatric, adolescent, and adult care, women's health, annual wellness exams, and management of conditions such as acne, eczema, elevated cholesterol, thyroid disorders, and gastrointestinal disorders. Elite Medical Clinic also provides advanced lipid screening and counseling, lab and X-ray services, and minor suturing and procedures. They are committed to personalized health care for every patient. You can download new patient documents and get appointment and insurance information online.
Website:
elite-med.ch
HQ:
Tupelo, US
Jurisdictions:
CH
Countries:
CH
Languages:
English, German, French
Response SLA:
24 hours
Onboarding time:
3–10 days
Pricing model:
Onboarding + annual retainer
Starting from:
CHF 2,500
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Swiss AR Services
Swissport is the leading global provider of airport ground services and air cargo handling, operating at 286 airports worldwide. They offer a comprehensive portfolio of safe, reliable, and sustainable services.
Swissport International AG stands as the premier global provider of airport ground services and air cargo handling, distinguished by its revenue and extensive network of 286 airports across six continents. The company is committed to delivering operational excellence and trusted customer experiences through safe, reliable, and sustainable airport services. Their service portfolio is the industry's widest single-source offering, catering to a diverse clientele. Swissport emphasizes a strong focus on safety, operational excellence, industry expertise, customer partnership, sustainability, and leading innovation. They are dedicated to providing a seamless and efficient experience for airlines and passengers alike, solidifying their position as a leader in the aviation services sector.
Website:
swissport.com
HQ:
Zurich, Switzerland
Jurisdictions:
CH
Countries:
CH
Languages:
English, German, French
Response SLA:
24 hours
Onboarding time:
2–7 days
Pricing model:
Onboarding + annual retainer
Starting from:
CHF 2,200
Services:
Local Contact
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The Tao of Excellence
The Tao of Excellence GmbH is a Swiss-based consultancy specializing in quality management and regulatory compliance for the medical device industry. They offer expert solutions for MDR, IVDR, and MDSAP certifications, aiming for efficient market access and sustainable business processes.
The Tao of Excellence GmbH, based in Schaffhausen, Switzerland, provides specialist consulting services tailored for the medical devices industry. They focus on ensuring regulatory compliance and market success through expert guidance on MDR, IVDR, and MDSAP certifications. Their services encompass Quality Management Systems (QMS/eQMS), Six Sigma training, Gap Analysis, Clinical Evaluation Reports, audit readiness, data analysis, business intelligence, digitalization, and agile business development. With a proven track record of over 50 audits and extensive experience in quality management within dynamic international companies, The Tao of Excellence GmbH offers solutions designed for safer, faster, and more cost-effective processes. They emphasize a solution-oriented, flexible, and positive approach, leveraging creative and innovative ideas alongside long-term practical experience to meet client objectives. Their team of dedicated experts is committed to providing honest, relevant work, fostering an open, efficient, and respectful environment. They aim to optimize business processes and procedures, secure compliance with medical device regulations, and enable organizations to achieve regulatory and commercial success through productive and cost-effective solutions adapted to evolving market needs.
Website:
taoexcellence.ch
HQ:
Schaffhausen, CH
Jurisdictions:
CH
Countries:
CH
Languages:
English, German, French
Response SLA:
48 hours
Onboarding time:
3–10 days
Pricing model:
Custom pricing
Starting from:
CHF 1,800
Device Classes:
Class I, Class IIa, Class IIb
Swiss Establishment:
Schaffhausen
Services:
Local Contact
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TAS SAT AG
TAS SAT AG offers expert regulatory services for medical devices and IVDs in Switzerland. They act as a CH-REP (Authorised Representative) and CH Importer, ensuring compliance with new Swiss regulations.
TAS SAT AG provides specialized regulatory services for medical devices and in vitro diagnostics (IVDs) within Switzerland. Following the termination of the Mutual Recognition Agreement with the EU, Switzerland now operates under its own Medical Devices Ordinance (MedDO) and Ordinance on In Vitro Diagnostic Medical Devices (IvDO), making it a "third country" for foreign manufacturers and distributors. As a Swiss-domiciled CH-REP (Authorised Representative), TAS SAT AG serves as a crucial liaison between non-Swiss manufacturers and Swiss authorities. They ensure compliance with Swiss laws, which is mandatory for selling medical devices and IVDs in the Swiss market. Their responsibilities include checking declarations of conformity, technical documentation, and manufacturer registration obligations, as well as reporting serious incidents and forwarding complaints. Additionally, TAS SAT AG can function as a CH Importer, acting as the point of contact for non-Swiss distributors to ensure compliance with Swiss import regulations for medical devices and IVDs. By leveraging their expertise, TAS SAT AG helps reduce the regulatory burden and associated financial costs for businesses entering the Swiss market.
Website:
ch-rep.me
HQ:
Zurich, CH
Jurisdictions:
CH
Countries:
CH
Languages:
English, German, French
Response SLA:
24 hours
Onboarding time:
2–7 days
Pricing model:
Onboarding + annual retainer
Starting from:
CHF 2,000
Device Classes:
IVD
Services:
Local Contact, Vigilance
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Inspera GmbH
Inspera GmbH is a provider listed in the ch_rep directory, specializing in core provider profile fields for directory listings.
Inspera GmbH is featured in the ch_rep directory, focusing on the extraction of core provider profile fields. This service is crucial for creating comprehensive and accurate directory listings, ensuring that essential information about providers is readily available to potential clients or partners. The ch_rep directory serves as a platform for showcasing specialized services, and Inspera GmbH's contribution highlights the importance of structured data in provider profiles. By concentrating on these core fields, Inspera GmbH aims to enhance the discoverability and utility of the directory for all its users.
Website:
inspera.ch
HQ:
Basel, CH
Jurisdictions:
CH
Countries:
CH
Languages:
English, German, French
Response SLA:
24 hours
Onboarding time:
3–10 days
Pricing model:
Onboarding + annual retainer
Starting from:
CHF 2,300
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Medidee Services SA
Medidee Services SA is a leading end-to-end consulting service provider for the MedTech industry, now part of Veranex. They offer comprehensive regulatory, clinical, and quality management solutions.
Medidee Services SA, now part of Veranex, is a premier end-to-end consulting service provider dedicated to the MedTech industry. They specialize in guiding companies through all product development stages, from initial concept to regulatory clearance and certification. Their expertise spans critical areas including Regulatory Affairs (CE-Marking, MDR/IVDR transition, US FDA submissions), Clinical Affairs (CRO services, clinical strategy, trial execution), and Quality Management Systems (ISO 13485, MDSAP). Medidee also provides specialized services such as EC Representative functions for non-EU manufacturers and GDPR data protection consulting. With a focus on integrating patient safety and business objectives, Medidee helps clients navigate complex regulatory landscapes, select appropriate pathways, and manage interactions with authorities and notified bodies. They offer tailored solutions for a wide range of medical devices, including In Vitro Diagnostics, Digital Health, Combination Products, and Implantables.
Website:
medidee.ch
HQ:
Lausanne, CH
Jurisdictions:
CH
Countries:
CH
Languages:
English, German, French
Response SLA:
48 hours
Onboarding time:
3–10 days
Pricing model:
Onboarding + annual retainer
Starting from:
CHF 2,400
Device Classes:
IVD
Services:
Vigilance, Named on Label
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Regulatory Globe GmbH
Regulatory Globe GmbH offers expert regulatory affairs services for medical devices, specializing in EU MDR and IVDR compliance. They provide regulatory intelligence, tools, and assistance for global market access.
Regulatory Globe GmbH is a specialized provider of regulatory affairs services for medical devices, focusing on compliance with EU MDR and IVDR regulations. They offer comprehensive support, including regulatory intelligence, implementation guides, and access to the latest EU documents. Their services are designed to help manufacturers navigate the complex landscape of medical device regulations. This includes providing tools and assistance, such as their RA Assistant 'Elly', to streamline the regulatory process. They aim to deliver global regulatory know-how directly to their clients. With a strong emphasis on the European market, Regulatory Globe GmbH assists companies in achieving and maintaining compliance, ensuring their medical devices can reach the market safely and efficiently. Their expertise covers various aspects of medical device classification and regulatory pathways.
Website:
regulatoryglobe.com
HQ:
Oberdorf, Switzerland
Jurisdictions:
CH
Countries:
CH
Languages:
English, German, French
Response SLA:
48 hours
Onboarding time:
3–10 days
Pricing model:
Custom pricing
Starting from:
CHF 1,900
Device Classes:
Class I, IVD
Swiss Establishment:
St. Gallen
Services:
Local Contact
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Regulatory Partners Switzerland
The European Medicines Agency (EMA) is a decentralized agency of the European Union responsible for the scientific evaluation, supervision, and safety monitoring of medicines in the EU. It ensures that medicines available in the EU are safe, effective, and of high quality.
The European Medicines Agency (EMA) is the EU's agency for the evaluation of medicinal products. It is responsible for the scientific evaluation, supervision, and safety monitoring of medicines in the EU. The EMA's mission is to protect and promote public and animal health through the evaluation and supervision of medicines for use in the European Union. The agency is located in Amsterdam, the Netherlands, and operates with a commitment to transparency and scientific excellence. It plays a crucial role in advancing safe, ethical, and aligned AI practices across the medicines lifecycle and provides regulatory guidance. The EMA works closely with national regulatory authorities in EU Member States to ensure a harmonized approach to medicine regulation across the Union. It also engages with international partners to promote global standards for medicine quality, safety, and efficacy.
Website:
regulatorypartners.ch
HQ:
Amsterdam, NL
Jurisdictions:
CH
Countries:
CH
Languages:
English, German, French
Response SLA:
48 hours
Onboarding time:
3–10 days
Pricing model:
Custom pricing
Starting from:
CHF 2,000
Device Classes:
Class I, Class IIa, Class IIb
Services:
Vigilance
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Swiss Regulatory Solutions
Regnology is a global leader in regulatory reporting technology, offering solutions and services for financial institutions and regulators worldwide. They provide expertise in risk, tax, and finance technology.
Regnology is a leading provider of regulatory reporting solutions, serving both regulators (RegTech) and the regulated (SupTech) globally. With a focus on financial, risk, and tax technology, they offer an expanded platform that integrates expertise and solutions to ensure compliance, risk management, and finance transformation. Their offerings include implementation services, system integration, process optimization, and managed services designed to reduce IT expenses and provide experts on demand. Regnology emphasizes collaboration, transparent communication, and tailored solutions to meet the unique needs of their thousands of clients worldwide. They also provide comprehensive customer success resources, including a dedicated support team, self-help documentation, training materials, and a customer academy for product and industry knowledge.
Website:
swissregulatorysolutions.ch
HQ:
Vienna, AT
Jurisdictions:
CH
Countries:
CH
Languages:
English, German, French
Response SLA:
48 hours
Onboarding time:
3–10 days
Pricing model:
Custom pricing
Starting from:
CHF 2,100
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MedTech Compliance Switzerland
Elos Medtech is a leading CDMO specializing in Medtech solutions for dental, orthopedic, and advanced surgical industries. They offer end-to-end services from R&D to manufacturing and sterile packaging.
Elos Medtech is a trusted partner for the world's leading dental, orthopedic, and advanced surgical companies, offering comprehensive CDMO services. They excel in reimagining partnerships to enhance lives through best-in-class technology and pioneering sustainable Medtech solutions. Their expertise spans the entire product lifecycle, including Research and Development, Prototyping using advanced techniques like additive manufacturing and CNC machining, and "Design for Manufacturing" to optimize cost-effectiveness and quality. Elos Medtech also provides crucial services such as Sterilization Management, Registration and Technical Documentation, and Supply Chain Management. With a commitment to integrity, respect, and quality, Elos Medtech drives innovation and value across the supply chain. They are dedicated to meeting the evolving needs of the medical device industry, ensuring efficient, high-quality manufacturing while adhering to regulatory requirements. Their presence across three continents allows for unmatched local service and tailored support to meet unique market needs.
Website:
medtechcompliance.ch
HQ:
Skara, Sweden
Jurisdictions:
CH
Countries:
CH
Languages:
English, German, French
Response SLA:
48 hours
Onboarding time:
3–10 days
Pricing model:
Custom pricing
Starting from:
CHF 2,000
Services:
Local Contact
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Swiss Medical Regulatory
The International Coalition of Medicines Regulatory Authorities (ICMRA) is a strategic coordinating entity for regulatory authorities, enhancing global communication, information sharing, and crisis response for medicines.
The International Coalition of Medicines Regulatory Authorities (ICMRA) is a voluntary, executive-level entity focused on strategic coordination, advocacy, and leadership among regulatory authorities. Its mission is to provide a global architecture that supports enhanced communication, information sharing, and crisis response, while also addressing regulatory science issues. ICMRA aims to tackle current and emerging human medicine regulatory and safety challenges on a global scale. The organization is designed to facilitate collaboration and streamline responses to critical issues within the field of medicine regulation. The website itself was designed by Swissmedic and is maintained by the Pharmaceuticals and Medical Devices Agency, indicating a collaborative effort in its operational infrastructure.
Website:
icmra.info
HQ:
Geneva, Switzerland
Jurisdictions:
CH
Countries:
CH
Languages:
English, German, French
Response SLA:
48 hours
Onboarding time:
3–10 days
Pricing model:
Custom pricing
Starting from:
CHF 2,100
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Compliance Switzerland AG
bluesign partners with the textile industry to minimize adverse impact across the value chain. They empower brands, manufacturers, and chemical suppliers to create safer, more responsible products.
bluesign is a global leader in certification and sustainability services for the textile industry. They partner with brands, manufacturers, and chemical suppliers to minimize adverse environmental and social impacts across the value chain. Their mission is to empower partners to create safer, more responsible products for society by meeting rising consumer and regulatory expectations with verifiable sustainability and certification. bluesign helps partners reduce waste, energy consumption, and chemical risks while improving compliance. They provide real-time insights and track sustainability progress with verified data, enabling partners to build consumer trust through verified sustainability insights and a transparent supply chain. By joining over 900+ System Partners in more than 50 countries, companies can drive sustainable innovation and gain recognition for their sustainable production practices.
Website:
complianceswitzerland.ch
HQ:
Baar, CH
Jurisdictions:
CH
Countries:
CH
Languages:
English, German, French
Response SLA:
48 hours
Onboarding time:
3–10 days
Pricing model:
Custom pricing
Starting from:
CHF 2,000
Swiss Establishment:
Aargau
Services:
Labeling, Local Contact, Vigilance
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Regulatory Consulting Switzerland
Voisin Consulting Life Sciences (VCLS) is a strategic partner for global HealthTech product development. They offer tailored, end-to-end services to accelerate market entry for pharmaceuticals and medical devices.
Voisin Consulting Life Sciences (VCLS) is a dedicated partner for accelerating the entry of HealthTech products into regulated markets, benefiting patients worldwide. They provide tailored, end-to-end services from preclinical stages through to product launch and beyond, ensuring products meet all regulatory and market access requirements for optimized and faster market entry. With integrated, in-house expertise, VCLS supports innovative pharma, biotech, and medical device developers and manufacturers. Their services cover a wide range of product types, including Small Molecules, Biologics, Cell, Gene & Tissue Therapies, Digital Health Products, Microbiome Products, and Combination Products. They cater to both emerging biotech companies and established pharmaceutical firms seeking additional support. VCLS is committed to operational excellence and building strong partnerships. They offer a "one-stop shop" approach, empowering clients every step of the way. The company also emphasizes a deep commitment to ESG principles, aiming for sustainable growth and responsible innovation.
Website:
regulatoryconsulting.ch
HQ:
Lausanne, Switzerland
Jurisdictions:
CH
Countries:
CH
Languages:
English, German, French
Response SLA:
48 hours
Onboarding time:
3–10 days
Pricing model:
Custom pricing
Starting from:
CHF 2,000
Services:
Local Contact, Vigilance
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Swiss MedTech Regulatory
Swiss Medtech is the voice of the Swiss medical technology industry, advocating for innovation and quality. They represent companies and promote the sector's advancements.
Swiss Medtech serves as the central voice for the Swiss medical technology industry. The organization is dedicated to fostering innovation, promoting quality developments, and advocating for the sector's interests. They actively engage in communication, publishing news, and developing concepts to highlight the value and impact of medtech. The association represents companies within the Swiss medtech landscape, working to ensure a favorable environment for growth and development. They are involved in key industry initiatives, such as discussions on regulatory changes like the MDR/IVDR and promoting advancements in areas like digitalization and data quality. Swiss Medtech also welcomes new members and provides resources like a member directory and event calendar. Their communication team is responsible for crafting compelling narratives and visuals that underscore the importance of medtech. They manage various communication channels, including their website, newsletters, and social media, ensuring that the industry's contributions are clearly articulated and widely recognized. Swiss Medtech is committed to advancing the Swiss medtech sector through strong representation and effective communication.
Website:
swissmedtechregulatory.ch
HQ:
Bern, CH
Jurisdictions:
CH
Countries:
CH
Languages:
English, German, French
Response SLA:
48 hours
Onboarding time:
3–10 days
Pricing model:
Custom pricing
Starting from:
CHF 2,000
Swiss Establishment:
Bern
Services:
Local Contact, Vigilance, Named on Label
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Swiss Regulatory Affairs
The Swiss Clinical Trial Organisation (SCTO) provides tools and expertise for clinical research professionals in Switzerland, focusing on regulatory affairs, data management, and project management.
The Swiss Clinical Trial Organisation (SCTO) is a nationwide network of interconnected platforms offering innovative tools and dynamic approaches for clinical research professionals. These tools are developed by experts across Switzerland in key fields, including regulatory affairs, data management, and project management, facilitating the smooth conduct of clinical study projects. The SCTO Platforms serve as pools of expertise, developing high-quality resources tailored to Swiss laws but adaptable worldwide. They aim to advance academic clinical research in Switzerland by fostering knowledge exchange and sharing best practices. The organisation is funded by the State Secretariat of Education, Research and Innovation and the Swiss National Science Foundation, with over 250 people working within its network.
Website:
sctoplatforms.ch
HQ:
Bern, CH
Jurisdictions:
CH
Countries:
CH
Languages:
English, German, French
Response SLA:
48 hours
Onboarding time:
3–10 days
Pricing model:
Custom pricing
Starting from:
CHF 2,000
Services:
Local Contact, Vigilance
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SMQS
SMQS acts as the Swiss Authorized Representative (CH-REP) for international medical device manufacturers, ensuring compliance with Swiss market access regulations and facilitating product registration and market entry.
Swiss Medical Quality Services (SMQS) serves as the Swiss Authorized Representative (CH-REP), assisting international manufacturers in obtaining market access for their medical devices (MDR/IVDR) within Switzerland. They manage formal and safety-related responsibilities for bringing products into the Swiss market, ensuring adherence to all legal requirements. SMQS offers comprehensive services including product registration support, compliance with legal provisions, and cooperation with authorities on preventive or corrective actions. Their expertise is built on years of experience with established companies in the Swiss medical and dental markets, providing a streamlined path for global manufacturers to enter and succeed in Switzerland.
Website:
smqs.ch
HQ:
Glattbrugg, CH
Jurisdictions:
CH
Countries:
CH
Languages:
English, German, French, Italian
Response SLA:
48 hours
Onboarding time:
3–14 days
Pricing model:
Custom pricing
Services:
Local Contact, Vigilance, Named on Label
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Medical Devices CH Rep
CMC Medical Devices GmbH is a leading consultancy providing in-country representation and global regulatory services for medical devices. They specialize in navigating Swissmedic regulations and ensuring market access.
CMC Medical Devices GmbH offers comprehensive regulatory and compliance services for medical device manufacturers seeking to enter and operate within the Swiss market. As an authorized representative (CH-REP), they act as the primary point of contact with Swiss authorities like Swissmedic, ensuring smooth communication and adherence to local regulations. Their expertise includes navigating the specific requirements for systems and procedure packs (SPPs) under the Medical Devices Ordinance (MedDO) and In Vitro Diagnostic Medical Devices Ordinance (IvDO). They assist with product registration, labeling, vigilance duties, and conformity assessments. CMC Medical Devices GmbH is committed to facilitating market access by providing personalized services that enable manufacturers to achieve regulatory compliance. They handle inquiries from authorities promptly and efficiently, minimizing delays and ensuring a smooth approval process for products entering Switzerland.
Website:
elite-med.ch
HQ:
Switzerland, Switzerland
Jurisdictions:
CH
Countries:
CH
Languages:
English
Response SLA:
48 hours
Onboarding time:
7–21 days
Pricing model:
Custom pricing
Services:
Labeling, Local Contact, Vigilance
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GlobalCompliance Solutions Pro
Leading global regulatory compliance consultancy serving medical device manufacturers worldwide with comprehensive regulatory services.
Website:
globalcompliance-solutions.com
HQ:
Boston, US
Jurisdictions:
EU, UK, US
Countries:
DE, FR, GB, US
Languages:
English, French, German, Spanish
Response SLA:
24 hours
Onboarding time:
7–30 days
Pricing model:
Custom pricing
Device Classes:
Class I, Class IIa, Class IIb
Swiss Establishment:
Zurich
Services:
Labeling, Local Contact, Vigilance
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MedReg International Pro
Specialized regulatory consultancy providing end-to-end compliance solutions for medical devices, IVDs, and combination products across all major markets.
Website:
medreg-international.com
HQ:
London, UK
Jurisdictions:
EU, UK, US
Countries:
DE, FR, GB, US
Languages:
English, French, German, Spanish
Response SLA:
24 hours
Onboarding time:
7–30 days
Pricing model:
Custom pricing
Device Classes:
Class I, Class IIa, Class IIb
Swiss Establishment:
Zurich
Services:
Labeling, Local Contact, Vigilance
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Regulatory Excellence Partners Pro
Boutique regulatory consultancy offering personalized, high-touch regulatory services for innovative medical device companies and startups.
Website:
regulatoryexcellence.com
HQ:
San Francisco, US
Jurisdictions:
EU, UK, US
Countries:
DE, FR, GB, US
Languages:
English, French, German, Spanish
Response SLA:
24 hours
Onboarding time:
7–30 days
Pricing model:
Custom pricing
Device Classes:
Class I, Class IIa, Class IIb
Swiss Establishment:
Zurich
Services:
Labeling, Local Contact, Vigilance
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Comprehensive Buyer's Guide
1. Who Needs a Swiss Authorized Representative (CH-REP)?
Under Swiss Medical Devices Ordinance (MedDO, SR 812.213)[1] and In Vitro Diagnostic Devices Ordinance (IvDO, SR 812.219)[2], non-Swiss manufacturers placing medical devices or IVD on the Swiss market must appoint a Swiss Authorized Representative (also called CH-REP, CH REP, or SwissMedic representative)[1][2].
This requirement applies to:
- Non-Swiss medical device manufacturers placing devices on the Swiss market[1] — a CH-REP is mandatory for market access
- Non-Swiss IVD manufacturers placing IVD on the Swiss market[2] — requires CH REP services under Swiss regulations
- Manufacturers selling in Switzerland alongside EU or other markets — need a Swiss Authorized Representative for Swiss market access
- New market entrants from outside Switzerland — must appoint a CH-REP before placing devices on the Swiss market
Note: The CH-REP must be established in Switzerland[1][2] and cannot be the same entity as your importer or distributor for the same device[1][2]. Switzerland has its own regulatory framework administered by SwissMedic, separate from EU regulations.
References
- Swiss Medical Devices Ordinance (MedDO, SR 812.213) (Swiss Federal Council) — 2021-05-01 — Article 51
2. What Services Are Typically Included?
CH-REP services (also called CH REP services or Swiss Authorized Representative services) typically include:
- Regulatory representation: Acting as your legal representative in Switzerland for regulatory purposes under the Swiss Medical Devices Ordinance (MedDO)[1] — the CH-REP fulfills this core requirement
- Technical documentation access: Maintaining access to your technical documentation for SwissMedic inspections and audits[1] — required for CH REP compliance
- SwissMedic communication: Serving as primary contact point with Swiss competent authorities for all regulatory matters[1] — the Swiss Authorized Representative handles all regulatory communications
- Vigilance support: Handling incident reporting, field safety corrective actions (FSCA)[1], and safety-related communications — essential for CH-REP compliance
- Post-market surveillance: Supporting PMS activities, periodic safety update reports (PSUR)[1], and trend analysis — part of CH REP services obligations
- Change notifications: Managing notifications for device changes, label updates, and design modifications to SwissMedic
- SwissMedic registration support: Assistance with device registration, UDI-DI submission, and Eudamed integration — some CH-REP providers offer registration assistance
- Labeling review: Verification of Swiss-specific labeling requirements including multilingual labels (German, French, Italian)[1] — Swiss Authorized Representative ensures labeling compliance
- Compliance monitoring: Tracking Swiss regulatory updates and ensuring ongoing compliance
Legal Basis: The CH-REP requirement is established under MedDO Art. 51(1)[1] for medical devices (SR 812.213) and IvDO Art. 44(1)[2] for in vitro diagnostic devices (SR 812.219). The CH-REP must be a natural or legal person established in Switzerland[1][2] and must be named in the device labeling[1][2].
References
- Swiss Medical Devices Ordinance (MedDO, SR 812.213) (Swiss Federal Council) — 2021-05-01 — Article 51
3. What Affects Pricing?
CH-REP pricing (also called CH REP pricing or Swiss Authorized Representative pricing) varies based on Switzerland-specific factors:
- SwissMedic alignment: Providers with established SwissMedic relationships may charge premium rates, but can expedite registrations and communications — affects CH-REP services pricing
- EU MDR/IVDR equivalence: Switzerland has adopted EU MDR/IVDR with Swiss-specific modifications[1]—providers must navigate both frameworks, which can affect CH REP pricing
- Official languages: Switzerland has four official languages (German, French, Italian, Romansh)[1]—providers offering multilingual support may charge more for Swiss Authorized Representative services
- SwissMedic interaction: Frequency of SwissMedic communications, registrations, and compliance activities specific to Swiss regulations[1] — affects CH-REP workload and pricing
- Multi-market strategy: If you're selling in both EU and Switzerland, some providers offer bundled CH-REP + EU AR services with pricing advantages
- Switzerland-specific regulatory context: Understanding of Swiss Therapeutic Products Act (TPA), MedDO[1], and SwissMedic ordinances—specialized knowledge commands premium rates for CH REP services
- Device classification: Class III[1] and IVD Class D devices typically cost more than Class I under Swiss regulations — CH-REP pricing reflects risk level
- Portfolio size: Number of devices and device families requiring SwissMedic registration — Swiss Authorized Representative providers may charge per device or per portfolio
- Service scope: Basic CH-REP representation vs. full regulatory support including SwissMedic registration, vigilance, and PMS[1]
- Contract terms: Annual retainer vs. per-device fees—Swiss market entry may require different pricing models than EU — CH REP pricing models vary by provider
References
- Swiss Medical Devices Ordinance (MedDO, SR 812.213) (Swiss Federal Council) — 2021-05-01 — Article 51
4. How to Choose a Provider
Key factors to consider when selecting a Swiss Authorized Representative:
- Swiss establishment: Verify they're established in Switzerland with a physical office and local staff[1] — required for CH-REP services
- Device class experience: Confirm experience with your device classifications (Class I, IIa, IIb, III[1], IVD) — essential for CH REP effectiveness
- MDR/IVDR expertise: Verify they understand Swiss regulations and EU alignment (Switzerland has adopted EU MDR/IVDR with Swiss-specific modifications[1]) — critical for Swiss Authorized Representative compliance
- Vigilance capabilities: Assess their incident reporting, FSCA handling[1], and SwissMedic communication track record — CH-REP must handle vigilance
- Response times: Verify SLA for SwissMedic requests (24-48h standard), change notifications, and emergency responses — CH REP responsiveness is critical
- Language capabilities: Switzerland has four official languages (German, French, Italian, Romansh)[1]—ensure Swiss Authorized Representative provider can handle required languages
- SwissMedic relationship: Providers with established SwissMedic relationships can expedite communications and registrations — valuable for CH-REP services
- Additional services: Check if they offer EU AR, PRRC, UK RP, or other complementary services for multi-market strategies
- Conflict of interest: Ensure they're not also your importer or distributor[1] (prohibited under Swiss regulations) — CH-REP must be independent
- References and track record: Request client references, especially for similar device types and classes — verify CH REP provider experience
RFP Checklist: When requesting quotes, provide: device classification and risk class, number of devices/SKUs, current markets (to identify synergies), timeline for Swiss market entry, special requirements (e.g., IVD, implantables, software as medical device), and expected change frequency.
References
- Swiss Medical Devices Ordinance (MedDO, SR 812.213) (Swiss Federal Council) — 2021-05-01 — Article 51
5. Legal Basis and Swiss Regulatory Framework
Swiss Medical Device Regulations: Switzerland has its own medical device regulatory framework administered by SwissMedic (Swiss Agency for Therapeutic Products)[1]. While Switzerland is not an EU member state, it has adopted the EU Medical Device Regulation (MDR 2017/745)[2] and In Vitro Diagnostic Regulation (IVDR 2017/746)[3] with Swiss-specific modifications[1].
Key Swiss Regulations:
- Therapeutic Products Act (TPA, SR 812.21): Primary legislation governing medical devices in Switzerland[1]
- Medical Devices Ordinance (MedDO, SR 812.213): Implementing ordinance that establishes CH-REP requirements (Article 51[1])
- SwissMedic Ordinances: Additional technical requirements for registration, vigilance, and market surveillance[1]
CH-REP Requirements (MedDO Art. 51[1]): Non-Swiss manufacturers must appoint a CH-REP who is established in Switzerland[1]. The CH-REP must be named on the device label and in the declaration of conformity[1]. The CH-REP cannot be the same legal entity as the importer or distributor[1]. The CH-REP must maintain technical documentation access for SwissMedic[1].
Mutual Recognition Agreement (MRA): Switzerland and the EU have a Mutual Recognition Agreement for conformity assessment[4], which means CE-marked devices can generally access the Swiss market (with CH-REP appointment[1]). However, manufacturers must monitor ongoing MRA status and any Swiss-specific requirements.
References
- Swiss Medical Devices Ordinance (MedDO, SR 812.213) (Swiss Federal Council) — 2021-05-01 — Article 51
- Regulation (EU) 2017/745 (MDR) (European Union) — 2017-04-05
- Regulation (EU) 2017/746 (IVDR) (European Union) — 2017-04-05
- EU-Switzerland Mutual Recognition Agreement (MRA) (SwissMedic) — 2021-01-01
6. CH-REP Onboarding Checklist
Documentation Required:
- Technical Documentation: Complete technical files for all devices (design dossiers, risk analysis, clinical evaluation, verification/validation)[1]
- CE Certificates: Valid CE certificates from EU Notified Body (if applicable for device class)[1]
- Declaration of Conformity: Signed DoC for each device or device family[1]
- Labels and IFU: Current labeling and instructions for use (must include CH-REP name and address[1])
- Quality Management System: ISO 13485[2] certificate and QMS documentation
- Post-Market Surveillance Plan: PMS plan and procedures[1]
- Vigilance Procedures: Incident reporting and FSCA procedures[1]
- Manufacturer Information: Company registration, authorized signatories, contact details
Onboarding Steps:
- Initial Assessment (Week 1): CH-REP provider reviews device portfolio, classification[1], and documentation completeness
- Contract Execution (Week 1-2): Negotiate and sign CH-REP agreement, define scope and SLAs
- Documentation Review (Week 2-3): Swiss Authorized Representative provider reviews technical files, identifies gaps, requests missing information
- Label Updates (Week 3-4): Update labels and IFU to include CH-REP name and address[1]
- SwissMedic Registration (Week 4-6): Submit device registration to SwissMedic (if required[1]), obtain registration confirmation
- Market Launch (Week 6+): Begin placing devices on Swiss market, establish vigilance and PMS processes[1]
Timeline Expectations: Simple portfolios with complete documentation: 4-6 weeks. Complex portfolios or incomplete documentation: 8-12 weeks. Expedited CH REP services available for urgent market access needs.
References
- Swiss Medical Devices Ordinance (MedDO, SR 812.213) (Swiss Federal Council) — 2021-05-01 — Article 51
- ISO 13485:2016 — Medical devices — Quality management systems (ISO) — 2016-03-01
7. Timeline and Market Access Expectations
Typical Timeline for Swiss Market Entry:
- CH-REP Appointment: 2-4 weeks (with complete documentation) — Swiss Authorized Representative onboarding
- SwissMedic Registration: 4-8 weeks (varies by device class[1] and complexity) — CH-REP providers may assist
- Label Updates and Printing: 2-4 weeks (depending on label complexity and printing lead times) — labels must include CH-REP details[1]
- Importer/Distributor Setup: 2-6 weeks (if establishing new distribution channels)
- Total Time to Market: 8-16 weeks from CH-REP selection to first sales
Ongoing Timeline Considerations:
- Change Notifications: Submit to SwissMedic 30-60 days before implementation (depending on change type[1]) — CH REP services handle notifications
- Vigilance Reporting: Serious incidents must be reported within 10-15 days (depending on severity[1]) — Swiss Authorized Representative handles reporting
- PSUR Submission: Periodic safety update reports due annually or per device-specific schedule[1] — CH-REP supports PSUR obligations
- Certificate Renewals: CE certificates typically valid 3-5 years; plan renewals 6-12 months in advance
Expedited Market Access: Some CH-REP providers offer fast-track services for urgent market entry (e.g., 2-3 week onboarding). Expedited CH REP services typically incur 20-50% premium fees and require complete, high-quality documentation upfront.
References
- Swiss Medical Devices Ordinance (MedDO, SR 812.213) (Swiss Federal Council) — 2021-05-01 — Article 51
Frequently Asked Questions
Q1: What does a CH-REP do for medical devices?
A Swiss Authorized Representative (also called CH-REP, CH REP, or SwissMedic representative) is a legal entity established in Switzerland that acts on behalf of non-Swiss manufacturers to fulfill regulatory obligations for placing medical devices on the Swiss market under the Swiss Medical Devices Ordinance (MedDO, SR 812.213)[1]. The CH-REP serves as the manufacturer's representative and is responsible for ensuring devices comply with Swiss medical device regulations (SwissMedic)[1]. Key responsibilities include: verifying the manufacturer has appropriate technical documentation and quality management systems[1], keeping technical documentation available for SwissMedic[1], cooperating with SwissMedic on corrective actions and field safety notices[1], informing SwissMedic of device incidents and field safety corrective actions[1], forwarding communications from SwissMedic to the manufacturer[1], and acting as a contact point between the manufacturer and Swiss authorities[1]. The CH-REP must be established in Switzerland[1] and cannot be the same entity as the importer or distributor[1].
References
- Swiss Medical Devices Ordinance (MedDO, SR 812.213) (Swiss Federal Council) — 2021-05-01 — Article 51
Q2: Can one provider support both EU AR and CH-REP?
Yes, many providers offer both EU Authorized Representative (EC REP)[1] and Swiss Authorized Representative (CH-REP) services[2], which can be convenient for manufacturers selling in both the EU and Switzerland. However, these are separate regulatory roles: EC REP is for the EU market (27 member states)[1], while CH-REP is specifically for the Swiss market[2]. When evaluating providers offering both CH REP services and EU AR services, confirm: their EU establishment location (for EC REP[1]) and Swiss establishment location (for CH-REP[2]), whether they can handle both roles under a single contract or require separate agreements, their experience with both EU MDR/IVDR and Swiss regulations[2], and their ability to coordinate between EU and Swiss authorities when needed. Some manufacturers prefer separate providers, while others value the convenience of a single provider for both markets.
References
- Regulation (EU) 2017/745 (MDR) — Article 11 (European Union) — 2017-04-05 — Article 11
- Swiss Medical Devices Ordinance (MedDO, SR 812.213) (Swiss Federal Council) — 2021-05-01 — Article 51
Q3: What drives CH-REP costs?
CH-REP pricing (also called CH REP pricing or Swiss Authorized Representative pricing) varies based on several factors: device classification (Class I, IIa, IIb, III[1], or IVD classes—higher risk classes typically cost more), portfolio size (number of devices and device families), service scope (basic CH-REP representation vs. full regulatory support including vigilance, PMS, etc.[1]), surveillance needs (post-market surveillance, periodic safety update reports[1]), change management (frequency of device changes requiring notifications to SwissMedic), and contract terms (annual retainer vs. per-device fees). Some CH REP services providers also charge setup fees, renewal fees, or fees for specific services like vigilance handling or SwissMedic registration support. Additionally, Switzerland's regulatory framework[1] may have specific requirements that affect pricing, so request detailed CH-REP pricing breakdowns to compare effectively.
References
- Swiss Medical Devices Ordinance (MedDO, SR 812.213) (Swiss Federal Council) — 2021-05-01 — Article 51
Q4: How quickly can CH-REP onboarding happen?
CH-REP onboarding timelines (also called CH REP onboarding) vary by provider and your readiness. Simple setups with complete documentation can take 2-4 weeks, while more complex portfolios may take 4-8 weeks. Factors affecting timeline include: completeness of your documentation (technical files[1], labeling[1], certificates[1]), Swiss Authorized Representative provider's processing speed and SwissMedic relationship, device complexity and classification[1], whether you need SwissMedic registration support[1], and any language or translation requirements (Switzerland has multiple official languages[1]). Many CH-REP services providers offer expedited services for urgent cases, though this typically incurs additional fees. Once the CH-REP is appointed and registered with SwissMedic[1], you can usually start placing devices on the Swiss market, though you'll need to ensure all other Swiss requirements are met.
References
- Swiss Medical Devices Ordinance (MedDO, SR 812.213) (Swiss Federal Council) — 2021-05-01 — Article 51
Q5: What should I compare when selecting a CH-REP?
When comparing CH-REP providers (also called CH REP or Swiss Authorized Representative providers), evaluate: Swiss establishment location (which canton/region they're based in[1]), device class experience (verify experience with your specific device classes, especially Class III[1]), MDR/IVDR transition support (if migrating from MDD/IVDD to MDR/IVDR[1]), vigilance and PMS capabilities (incident reporting, field safety corrective actions[1], periodic safety update reports[1]), responsiveness and SLA (response times for SwissMedic requests[1], change notifications), contract terms (flexibility, termination clauses, fee structures), and additional services (some CH-REP services providers offer PRRC services, EU AR, etc.). Also check references, ask about their largest clients, verify they're not also your importer or distributor[1] (which could create conflicts), and confirm their understanding of Swiss-specific regulatory requirements[1].
References
- Swiss Medical Devices Ordinance (MedDO, SR 812.213) (Swiss Federal Council) — 2021-05-01 — Article 51
Q6: What is the difference between CH-REP and EU Authorized Representative?
CH-REP (Swiss Authorized Representative)[1] and EU Authorized Representative (EC REP)[2] are similar roles but serve different markets. CH-REP is required for non-Swiss manufacturers placing devices on the Swiss market under Swiss medical device regulations[1]. EC REP is required for non-EU manufacturers placing devices on the EU market under EU MDR/IVDR[2]. While the roles are similar (both act as regulatory representatives, maintain technical documentation access, handle authority communications, and support vigilance), they operate under different regulatory frameworks[1][2]. Switzerland is not an EU member state, so manufacturers selling in both markets typically need both a CH-REP and an EC REP. Some providers offer both CH REP services and EU AR services, but they require separate establishments (Switzerland for CH-REP[1], EU for EC REP[2]) and may have different contract terms.
References
- Swiss Medical Devices Ordinance (MedDO, SR 812.213) (Swiss Federal Council) — 2021-05-01 — Article 51
- Regulation (EU) 2017/745 (MDR) — Article 11 (European Union) — 2017-04-05 — Article 11
Q7: Do I need CH-REP if I already have an EU Authorized Representative?
Yes, if you're selling in both the EU and Switzerland, you typically need both an EU Authorized Representative (EC REP)[1] and a Swiss Authorized Representative (CH-REP)[2]. Switzerland is not an EU member state and has its own medical device regulatory framework administered by SwissMedic[2]. The EC REP covers the EU market (27 member states)[1], while the CH-REP covers the Swiss market[2]. These are separate regulatory requirements[1][2], and one cannot substitute for the other. However, many providers offer both CH REP services and EU AR services, which can simplify management and coordination. When evaluating providers, confirm they have proper establishments in both jurisdictions[1][2] and can handle the distinct requirements of each market.
References
- Regulation (EU) 2017/745 (MDR) — Article 11 (European Union) — 2017-04-05 — Article 11
- Swiss Medical Devices Ordinance (MedDO, SR 812.213) (Swiss Federal Council) — 2021-05-01 — Article 51
Provider Comparison Table
| Provider | MDR/IVDR | Languages | Response SLA | |
|---|---|---|---|---|
| Emergo by UL | CH | Request quote | English, German | 24h |
| Obelis | CH | Request quote | English, German | 24h |
| MDSS | CH | Request quote | English, German | 24h |
| MedEnvoy | CH | Request quote | English, German | 24h |
| OMC Medical (CHREP) | CH | Request quote | English, German | 24h |
| Decomplix | CH | Request quote | English, German | Custom |
| Freyr (CH-Rep Services) | CH | Request quote | English, German | 24h |
| QbD Group | CH | Request quote | English, German | 24h |
| Qarad Suisse S.A. | CH | Request quote | English, German | 24h |
| Thema Med | CH | Request quote | English, German | Custom |
Sources & Official Guidance
-
Swissmedic — Medical devices market access
Official Swiss guidance on market access and CH-REP context.
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Medical Devices Ordinance (MedDO) — Swiss law
Primary Swiss ordinance governing medical devices.
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Swissmedic — Responsibilities and obligations
Official overview of responsibilities for economic operators.
Last Updated: 2026-02-03
Reviewed by: Cruxi Regulatory Affairs Team
