Obelis
Obelis Group
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.
About
**Who they are**
Obelis is a Swiss-based partner specializing in global regulatory compliance, with a focus on market access for various product categories in key regions including the EU, UK, US, and Switzerland. They offer comprehensive services to help manufacturers navigate complex regulatory landscapes.
**Expertise & scope**
* Mandatory designation of a Swiss-based Authorised Representative (CH-REP) for non-Swiss manufacturers since May 26, 2022, due to the Mutual Recognition Agreement's update.
* Services include acting as the Swiss Authorised Representative, product registration with Swissmedic, technical documentation preparation compliant with EU MDR and MedDO, and Swiss consultancy, legal, and training.
* Expertise in Medical Devices (MD), In-vitro Medical Devices (IVD), Cosmetics (COS), Toys, Food Supplements, and Motor Vehicles.
* Assistance with product registration via Swissmedic, as Switzerland does not have direct access to EUDAMED.
* Guidance on technical documentation requirements, including Post-Market Surveillance (PMS) plans and reports, and ensuring compliance with Annex II and III of EU MDR.
* Support for appointing a qualified Person Responsible for Regulatory Compliance (PRRC) as required by Swiss law and EU MDR.
* Advising on labeling requirements and post-market vigilance obligations.
**Reputation / proof points**
* Over 32 years of regulatory expertise.
* Offices in Brussels, UK, USA, Canada, and Switzerland to support compliance in important markets.
Obelis is a Swiss-based partner specializing in global regulatory compliance, with a focus on market access for various product categories in key regions including the EU, UK, US, and Switzerland. They offer comprehensive services to help manufacturers navigate complex regulatory landscapes.
**Expertise & scope**
* Mandatory designation of a Swiss-based Authorised Representative (CH-REP) for non-Swiss manufacturers since May 26, 2022, due to the Mutual Recognition Agreement's update.
* Services include acting as the Swiss Authorised Representative, product registration with Swissmedic, technical documentation preparation compliant with EU MDR and MedDO, and Swiss consultancy, legal, and training.
* Expertise in Medical Devices (MD), In-vitro Medical Devices (IVD), Cosmetics (COS), Toys, Food Supplements, and Motor Vehicles.
* Assistance with product registration via Swissmedic, as Switzerland does not have direct access to EUDAMED.
* Guidance on technical documentation requirements, including Post-Market Surveillance (PMS) plans and reports, and ensuring compliance with Annex II and III of EU MDR.
* Support for appointing a qualified Person Responsible for Regulatory Compliance (PRRC) as required by Swiss law and EU MDR.
* Advising on labeling requirements and post-market vigilance obligations.
**Reputation / proof points**
* Over 32 years of regulatory expertise.
* Offices in Brussels, UK, USA, Canada, and Switzerland to support compliance in important markets.
Additional information
Manufacturers seeking to place medical devices on the Swiss market must appoint a Swiss Authorised Representative (CH-REP) if they are not based in Switzerland. This role is critical following the end of mutual recognition with the EU for medical devices. Obelis facilitates this by assuming the CH-REP role, ensuring technical documentation is compliant with Swiss regulations (MedDO) and EU MDR, and managing product registration with Swissmedic. They emphasize the need for professionalism and qualifications at a level equivalent to EU IVDR standards for this role. For non-EU manufacturers without an existing EU Authorized Representative, appointing a Swiss Authorized Representative is an immediate requirement.
Key Highlights
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Obelis has over 32 years of regulatory expertise.
Source
“Are you a manufacturer looking to lighten your regulatory load by taking advantage of our 32 years of regulatory expertise?”
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Mandatory Swiss Authorised Representative (CH-REP) designation for non-Swiss manufacturers since May 26, 2022.
Source
“From 26 May 2022, it is mandatory that non-Swiss based manufacturers designate a Swiss-based Authorised Representative.”
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Specializes in market access for Medical Devices, Cosmetics, Toys, Food Supplements, and Motor Vehicles.
Source
“specializing in market access for Medical Devices, Cosmetics, Toys, Food Supplements, and Motor Vehicles across the EU, UK, US, and Switzerland.”
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Provides product registration with Swissmedic for the Swiss market.
Source
“We register your devices with SwissMedic.”
Certifications & Trust Signals
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Offices located in Brussels, UK, USA, Canada, and Switzerland.
Source
“With our headquarter office in Brussels and our offices in the UK, USA, Canada and Switzerland, the Obelis Group secures a prime position to support your compliance in those important markets.”
Buyer Snapshot
Best for
- Non-Swiss manufacturers of medical devices, IVDs, cosmetics, toys, food supplements, and motor vehicles requiring market access in Switzerland.
- Companies needing to appoint a Swiss Authorised Representative (CH-REP).
How engagement typically works
- Consultative approach to navigate complex Swiss regulations.
- End-to-end service for regulatory compliance and market access.
Typical deliverables
- Designation as Swiss Authorised Representative (CH-REP).
- Swissmedic product registration.
- Technical documentation review and preparation.
- Regulatory consultancy and training.
Good to know
- Best when requiring a professional agency to act as Swiss Authorised Representative.
- Ideal for manufacturers unfamiliar with Swiss regulatory requirements post-MRA update.
HQ:
Brussels, BE
Languages:
English, German, French
Timezones:
Europe/Zurich
Claim status:
Listed
Services & Capabilities
Best CH-REP (Swiss Authorized Rep) | Compare & Get Quotes
Jurisdictions:
CH
Countries:
CH
Industries:
Medical devices, IVD
Portfolio:
100+
Onboarding time:
1–5 days
Pricing model:
Retainer
Starting from:
CHF 3,500
Included services:
Swissmedic contact point handling, Vigilance and incident reporting coordination, Labeling/packaging CH-REP information alignment, Mandate administration and documentation availability
Device Classes Supported:
Class I, IVD
Vigilance Contact Support:
Yes
Labeling Support:
Yes
Swiss Local Contact:
Yes
Can Be Named On Label:
Yes
Swiss Entity Canton Or Region:
Baar / ZG (Canton of Zug)
Additional ch_rep Details
Included Services Detailed
Initial portfolio intake and mandate setup for Swiss representation, Operational workflow for Swissmedic queries and manufacturer responses, Support for labeling text placement adjacent to the CH-REP symbol and address details, Coordination of vigilance reporting and field safety corrective actions
Excluded Services
Notified Body certification services, Legal representation in disputes, Distributor commercial management
Onboarding Steps
Manufacturers established in an EU/EEA state or with an EU/EEA Authorized Representative have specific deadlines to appoint a Swiss Authorized Representative. Non-EU manufacturers without an EAR must appoint a Swiss Authorized Representative immediately. Registration with Swissmedic is required to obtain the CHRN.
Local Entity Details
Swiss-based legal entity available to act as CH-REP under MedDO/IvDO (seed summary).
Device Classes Supported
Medical Devices (MD), In-vitro Medical Devices (IVD)
Supports MDR
Yes
Supports IVDR
Yes
Swiss Entity Canton Or Region
Baar / ZG
Labeling Support
Yes
Swiss Local Contact
Yes
Vigilance Contact Support
Yes
Can Be Named On Label
Yes
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