Importer & Distributor Compliance Support
Compare providers supporting importer and distributor compliance obligations. Request quotes and find partners for documentation, workflows, and compliance readiness.
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1,200+
Companies served
24h
Avg. response time
500+
RFQs this month
95%
Satisfaction rate
Compare Importer & Distributor Compliance Support Providers
For the most complete service details (including category-specific capabilities and requirements), open any provider profile below. Each profile contains full coverage, service details, and a direct quote request flow.
TÜV SÜD
TÜV SÜD is a leading testing, inspection, and certification company providing comprehensive medical device compliance services including importer/distributor compliance, MDR/IVDR consulting, and regulatory services. They offer both certification services and training programs for medical device manufacturers.
MedTech Europe serves as the European trade association for the medical technology industry, encompassing diagnostics, medical devices, and digital health. Their mission is to facilitate access to innovative medical technologies for more people while supporting healthcare systems in achieving sustainability. MedTech Europe actively engages with policymakers and stakeholders to promote policies that align with Europe's growing healthcare needs and expectations. They emphasize the value of medical technology through research, data, communications, industry events, and training. The association plays a crucial role in addressing key industry issues, including regulations like the EU MDR and IVDR, market access, and the advancement of digital health. They represent manufacturers and strive to foster an environment that supports innovation and responsible data use within the European Health Data Space. Founded in 2012, MedTech Europe is committed to shaping the future of healthcare by advocating for policies that enable the medical technology industry to meet evolving healthcare demands and improve patient outcomes.
Website:
tuvsud.com
HQ:
Brussels, Belgium
Jurisdictions:
EU
Countries:
DE, AT, CH, FR, IT, ES, NL, BE
Languages:
English, German
Response SLA:
48 hours
Onboarding time:
7–14 days
Pricing model:
Per project
Starting from:
EUR 900
Role Coverage:
Both
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BSI
BSI is a leading certification, testing, and training organization providing comprehensive medical device compliance services including importer/distributor compliance, MDR/IVDR consulting, and regulatory services. They offer both certification services and training programs for medical device manufacturers.
BSI stands as a premier training provider, specializing in management systems and organizational resilience. Their deep involvement in developing many of the world's leading standards translates into unparalleled expertise for their clients. With a commitment to delivering world-leading industry experts and innovative training solutions, BSI has earned high ratings from a vast number of clients. They offer a comprehensive suite of training courses designed to meet diverse organizational needs. Their training catalog includes specialized areas such as Aerospace AS9100:2016, Anti-Bribery, Artificial Intelligence (AI), Automotive IATF 16949:2016, Building Information Modelling (BIM), Business Continuity ISO 22301, Cloud Security, Cybersecurity, Energy Management ISO 50001, Environment ISO 14001, Environmental Health & Safety (EHS), and Food & Safety.
Website:
bsigroup.com
HQ:
Reston, United States
Jurisdictions:
EU, UK
Countries:
GB, IE, DE, FR, NL, BE
Languages:
English
Response SLA:
24 hours
Onboarding time:
7–18 days
Pricing model:
Per project
Starting from:
GBP 800
Role Coverage:
Both
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SGS (MedTech Training)
SGS North America provides comprehensive environmental testing services, including drinking water, soil, sediment, wastewater, solid waste, and contaminated site analysis. They offer solutions for regulatory compliance and project-specific challenges.
SGS North America is a leading provider of environmental testing services, offering a wide range of analytical solutions to meet diverse industry needs. Their expertise spans critical areas such as drinking water analysis, soil and sediment testing, wastewater and solid waste characterization, and contaminated site assessment and remediation. With a commitment to accuracy and regulatory compliance, SGS North America supports clients in navigating complex environmental challenges. They provide services for various sectors, including agriculture, building and infrastructure, consumer products, industrial manufacturing, and more. Their offerings include advanced analytical methods for detecting a broad spectrum of contaminants, from emerging pollutants to legacy compounds. SGS North America leverages its extensive network and advanced laboratory capabilities to deliver reliable data and actionable insights. They assist clients in ensuring product safety, environmental protection, and adherence to stringent regulations. Their services are designed to address unique project requirements and support informed decision-making in environmental management.
Website:
sgs.com
HQ:
Geneva, US
Jurisdictions:
EU, UK
Countries:
CH, DE, FR, IT, ES, GB
Languages:
English, French
Response SLA:
24 hours
Onboarding time:
7–21 days
Pricing model:
Per project
Starting from:
EUR 850
Role Coverage:
Both
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Intertek
Intertek is a leading global provider of testing, inspection, certification, and auditing services for medical devices, pharmaceuticals, and consumer products. They offer comprehensive compliance and quality assurance services worldwide.
Website:
intertek.com
HQ:
London, GB
Jurisdictions:
EU, UK
Countries:
GB, IE, SE, DE, FR
Languages:
English
Response SLA:
24 hours
Onboarding time:
4–18 days
Pricing model:
Per project
Starting from:
GBP 750
Role Coverage:
Both
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Emergo by UL (Importer/Distributor MDR Webinar)
Emergo by UL offers comprehensive regulatory consulting and compliance services for medical devices and IVDs. They specialize in market access, human factors, privacy, security, and device registration globally.
Emergo by UL provides expert regulatory consulting and compliance solutions tailored for medical device and IVD manufacturers navigating global markets. Their services encompass market access strategies, human factors research and design, privacy and security consulting (including HIPAA and GDPR), and end-to-end device registration support. Leveraging extensive expertise, Emergo by UL assists clients with in-country representation, post-market surveillance, and regulatory affairs management. They offer digital tools and platforms to streamline regulatory activities, enhance compliance, and provide access to critical industry insights. Their offerings are designed to help companies evolve with the changing healthcare landscape and achieve successful product launches worldwide.
Website:
emergobyul.com
HQ:
Amsterdam, US
Jurisdictions:
EU
Countries:
NL, DE, FR, IT, ES, BE
Languages:
English
Response SLA:
72 hours
Onboarding time:
4–12 days
Pricing model:
Retainer
Starting from:
EUR 2,500
Role Coverage:
Both
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MedEnvoy (Regulatory Importer Services)
MedEnvoy provides expert regulatory importer services for medical devices and IVDs across the EU, UK, and Switzerland. They ensure compliance with MDR, IVDR, and UK MHRA regulations, acting as your independent importer, EUAR, UKRP, and CH-REP.
MedEnvoy specializes in navigating the complex regulatory landscape for medical device and IVD manufacturers seeking to expand into international markets. As a leading Regulatory Importer Services provider, they offer crucial support across the EU, UK, and Switzerland. Their services include acting as an independent EU Importer (EUAR), UK Importer (UKRP), and Swiss Importer (CH-REP). MedEnvoy ensures compliance with the EU MDR/IVDR, UK MHRA regulations, and Swiss MedDO, minimizing disruption to product release and shipping processes. They develop streamlined processes and contractual arrangements to prevent redundant efforts and ensure adherence to all mandated tasks. MedEnvoy also offers Medical Distributor Selection & Management, ISO Certified Translation Services, UK Tax Relief Services, and Medical Device QA/RA Outsourcing Services. They are committed to providing jargon-free, effective solutions to help companies understand their requirements and achieve compliance efficiently.
Website:
shirobusiness.com
HQ:
Seattle, Netherlands
Jurisdictions:
EU, UK, CH
Countries:
DE, FR, NL, BE, GB, CH
Languages:
English
Response SLA:
24 hours
Onboarding time:
5–24 days
Pricing model:
Retainer
Starting from:
USD 3,000
Role Coverage:
Importer
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MedNet EC-REP (Regulatory Importer)
MedNet EC-REP is your expert partner for regulatory representation in European markets, ensuring seamless access for non-EU products to the EU, Great Britain, and Switzerland.
MedNet EC-REP specializes in providing comprehensive regulatory representation for non-EU manufacturers seeking to access European markets. As your European Authorized Representative (EC-REP), UK Responsible Person (UK RP), and Swiss Authorized Representative, we facilitate market entry for medical devices, in-vitro diagnostics, cosmetics, and personal protective equipment. Our services encompass ensuring sustained product compliance throughout its lifecycle, managing regulatory inquiries, mitigating risks, and acting as the primary contact point for competent authorities. We offer specialized support for clinical investigations, IVD performance evaluations, and product registration across the EU, UK, and Switzerland, navigating complex regulations like MDR and IVDR. With headquarters in Germany and a strong presence in the UK and Switzerland, MedNet EC-REP guarantees fast communication and a deep understanding of local regulations. We help you achieve CE marking, manage labeling requirements, and obtain Free Sales Certificates for global market expansion, ensuring your products meet all necessary standards for safety and effectiveness.
Website:
mednet-ecrep.com
HQ:
Germany, Germany
Jurisdictions:
EU
Countries:
DE, AT, NL, BE, FR
Languages:
English, German
Response SLA:
48 hours
Onboarding time:
2–22 days
Pricing model:
Retainer
Starting from:
EUR 2,800
Role Coverage:
Importer
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Specculo (EU Regulatory Importer)
Specculo is an EU Regulatory Importer, ensuring compliance for products entering the European market. They facilitate smooth market access for businesses.
Specculo serves as a dedicated EU Regulatory Importer, streamlining the process for companies looking to introduce their products into the European market. Their expertise lies in navigating the complex regulatory landscape, ensuring that all necessary compliance requirements are met for seamless market entry. By acting as the importer of record, Specculo manages the responsibilities associated with bringing goods into the EU, offering peace of mind to manufacturers and distributors alike. They are committed to facilitating efficient and compliant trade within the European Union.
Website:
specculo.com
HQ:
Balzan, DE
Jurisdictions:
EU
Countries:
FR, BE, DE, NL, ES, IT
Languages:
English, French
Response SLA:
48 hours
Onboarding time:
5–16 days
Pricing model:
Retainer
Starting from:
EUR 2,000
Role Coverage:
Importer
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Kinesis Medical (EU Importer + 3PL)
Kinesis Medical offers specialized 3PL, EU Importer, and VAT management services for medical device manufacturers expanding into the EU market. They provide tailored logistics solutions from their strategic location in the Netherlands.
Kinesis Medical is a dedicated Third-Party Logistics (3PL) provider focused exclusively on medical devices. They assist medical device companies with their entire supply chain, from warehousing and order fulfillment to VAT management and acting as the EU Importer to navigate MDR/IVDR compliance. Strategically located in Tilburg, the Netherlands, Kinesis Medical leverages excellent transport connections to serve as a gateway to Europe and the rest of the world. Their services include temperature-controlled storage, transparent inventory control, product traceability, and efficient shipping solutions utilizing major carriers. For companies looking to establish a presence or streamline operations within the EU, Kinesis Medical offers VAT management services, including VAT registration and administration, to ensure compliance and optimize financial activities. They also act as the EU Importer, taking on the regulatory burdens associated with the MDR and IVDR, thereby removing obstacles for manufacturers and their distributors.
Website:
kinesismedical.com
HQ:
Tilburg, NL
Jurisdictions:
EU
Countries:
NL, BE, DE
Languages:
English, Dutch
Response SLA:
48 hours
Onboarding time:
3–16 days
Pricing model:
Custom pricing
Starting from:
EUR 2,500
Role Coverage:
Importer
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GrowthMedics (Regulatory Importing MDR/IVDR)
GrowthMedics accelerates global market expansion for Lifescience companies, specializing in regulatory importing (MDR/IVDR), sales representation, and digital marketing across Europe and the Middle East.
GrowthMedics is a dedicated partner for MedTech, IVD, and CMO manufacturers seeking to accelerate their global market entry and sales growth, particularly within European and Middle Eastern healthcare markets. They offer comprehensive services including regulatory importing (MDR/IVDR, MHRA), turnkey market expansion, and localized digital healthcare marketing strategies. Leveraging deep industry expertise and a network of over 7500+ qualified contacts including hospitals, distributors, OEMs, and KOLs, GrowthMedics provides on-the-ground sales representation and business development. They act as an extension of your sales team, operating in local time zones, speaking multiple languages, and managing distributor relationships, tradeshows, and lead generation. Their services are designed to de-risk market entry for innovative start-ups and scale-up manufacturers, offering cost-effective approaches and co-investment opportunities. GrowthMedics focuses on driving awareness, generating qualified leads, and facilitating sustainable commercial success through tailored go-to-market strategies and transparent reporting.
Website:
growthmedics.com
HQ:
Amsterdam, Netherlands
Jurisdictions:
EU, UK, CH
Countries:
NL, BE, DE, GB, CH
Languages:
English
Response SLA:
72 hours
Onboarding time:
2–12 days
Pricing model:
Retainer
Starting from:
EUR 2,200
Role Coverage:
Both
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mdi Europa (EU Importer Services)
mdi Europa GmbH is a German-based company specializing in regulatory affairs for medical device manufacturers. They offer services like CE Marking, EU Authorized Representation, and compliance consulting.
Founded in March 2000, mdi Europa GmbH provides flexible and tailored service packages to help medical device manufacturers worldwide comply with EU legislation, including the Medical Devices Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR). They act as a European Authorized Representative for numerous companies, assisting with CE Marking and registrations with European competent authorities. Their lean structure ensures efficient pricing and reliable guidance from a single point of contact throughout all processes. mdi Europa GmbH offers a comprehensive suite of compliance solutions, including CE Marking, MDR/IVDR compliance, Certificates of Free Sale, OEM/Private Labeling, Technical File Compilation, Declaration of Conformity, and consulting for electrical equipment (EMC/LVD) and environmental requirements (WEEE/RoHS). They pride themselves on their highly qualified regulatory affairs specialists and a global network of experts.
Website:
mdi-europa.com
HQ:
Langenhagen, Germany
Jurisdictions:
EU
Countries:
DE, AT, NL
Languages:
English, German
Response SLA:
24 hours
Onboarding time:
5–21 days
Pricing model:
Retainer
Starting from:
EUR 1,800
Role Coverage:
Importer
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Casus Consulting (Importer/Distributor Requirements)
Casus Consulting specializes in guiding businesses through importer and distributor compliance requirements. They offer expertise to ensure smooth operations in regulated markets.
Casus Consulting is a dedicated partner for businesses navigating the complexities of importer and distributor compliance. They provide specialized services to ensure that companies meet all regulatory obligations, facilitating seamless entry and operation within target markets. Their expertise covers a broad range of compliance areas, helping clients avoid pitfalls and maintain operational integrity. Whether your business is importing goods or acting as a distributor, Casus Consulting offers tailored solutions to address your specific needs. They understand the nuances of international trade regulations and domestic compliance laws, offering strategic advice and practical support. Their goal is to empower clients with the knowledge and tools necessary to achieve and maintain compliance, fostering trust and long-term success.
Website:
casusconsulting.com
HQ:
London, United Kingdom
Jurisdictions:
EU, UK
Countries:
GB, IE, DE, FR, NL, BE
Languages:
English
Response SLA:
48 hours
Onboarding time:
4–21 days
Pricing model:
Per project
Starting from:
GBP 1,500
Role Coverage:
Both
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Johner Institute (Distributor Requirements Guidance)
Johner Institute provides expert guidance on medical device regulations, quality management systems, and software development. They assist manufacturers in navigating complex compliance landscapes for market access.
The Johner Institute specializes in helping medical device manufacturers develop safe products and navigate complex global regulations. They offer expertise in areas such as MDR/IVDR compliance, quality management systems (ISO 13485), risk management (ISO 14971), and software development (IEC 62304). Their services include market access support for US and international markets, IVD admission strategies, and guidance on AI medical devices. They also provide training and consulting to ensure compliance and facilitate market entry. With a mission to help companies develop safe medical products efficiently and promote professional development, Johner Institute acts as a trusted partner for both small and large organizations. They are committed to excellence, honesty, and sustainable problem-solving in the healthcare IT and medical technology sectors.
Website:
blog.johner-institute.com
HQ:
Konstanz, DE
Jurisdictions:
EU
Countries:
DE, AT, CH
Languages:
English, German
Response SLA:
48 hours
Onboarding time:
2–19 days
Pricing model:
Per project
Starting from:
EUR 1,200
Role Coverage:
Both
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Open Regulatory (MDR Templates Library)
OpenRegulatory offers AI-powered eQMS software and consulting for medical device compliance, simplifying EU MDR, FDA, and Health Canada audits for lean teams.
OpenRegulatory provides an AI-powered eQMS called Formwork, designed for lean teams to streamline medical device compliance for EU MDR, FDA, and Health Canada. Their mission is to make regulatory compliance transparent, accessible, and free, offering open templates, pricing, and a playbook. Formwork replaces traditional tools like Google Drive and Jira with a purpose-built system that passed EU MDR and FDA audits. They also offer consulting services, including workshops and pay-as-you-go support, to help companies navigate classification, certification roadmaps, and documentation. Their Formwork eQMS comes in various editions, including a free Community Edition, a Starter package, and a comprehensive QMS + Techdoc tier. These solutions are built to be ISO 13485 and EU MDR ready, featuring real-time completeness checks, audit-proof e-signatures (FDA 21 CFR Part 11), and advanced AI features for document generation. OpenRegulatory emphasizes transparency and accessibility, providing free learning resources and a community forum alongside their paid offerings.
Website:
openregulatory.com
HQ:
Stockholm, DE
Jurisdictions:
EU
Countries:
SE, DE, FR, NL, BE
Languages:
English
Response SLA:
24 hours
Onboarding time:
4–12 days
Pricing model:
Per project
Starting from:
EUR 500
Role Coverage:
Both
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Maven Professional Services (Template Packs)
Gradle provides open-source build automation tools and professional services for developers, accelerating software delivery and enhancing productivity. They offer training, support, and consulting for enterprise build infrastructures.
Gradle Inc. is the company behind the popular open-source build system, Gradle Build Tool, which accelerates developer productivity for Java, Android, and Kotlin projects. They offer professional services including training, support, and consulting to help enterprises optimize their build infrastructures and continuous delivery pipelines. With extensive experience in enterprise build environments, Gradle Inc. partners with clients to understand their needs and propose tailored solutions. Their services also extend to build migration, performance profiling, and tooling integrations. Founded in 2010 to meet the growing demand for consulting services, Gradle Inc. has become a critical tool for developers worldwide, with over 50 million downloads per month. They also offer Develocity, a platform providing deep observability, build and test acceleration, and rapid troubleshooting features to support software development at scale.
Website:
mavenprofserv.com
HQ:
Hollister, USA
Jurisdictions:
EU, UK
Countries:
GB, IE, DE, FR, NL, BE
Languages:
English
Response SLA:
24 hours
Onboarding time:
5–20 days
Pricing model:
Per SKU
Starting from:
GBP 600
Role Coverage:
Both
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Oriel STAT A MATRIX (Document Control & SOP Training)
Oriel STAT A MATRIX offers expert QA/RA consulting, auditing, and training for the life sciences industry. They specialize in medical device compliance, AI governance, and regulatory transitions like QMSR and EU AI Act.
Oriel STAT A MATRIX provides specialized QA/RA consulting, auditing, and training services tailored for the life sciences sector. They assist organizations in meeting complex regulatory requirements, enhancing operational efficiency, and ultimately improving patient outcomes. Their expertise covers critical areas such as EU MDR compliance, ISO 27001 ISMS, software validation, risk management (ISO 14971), and FDA software classification. Oriel STAT A MATRIX is at the forefront of regulatory changes, offering training and guidance on emerging standards like AI Governance for Life Sciences (ISO 42001) and navigating the FDA's QMSR transition to an ISO 13485-based framework. They also provide support for integrating AI into medical devices and understanding the implications of the EU AI Act alongside MDR/IVDR. For those needing rapid upskilling without intensive multi-day courses, their "DaySmart" training classes offer a flexible and cost-effective solution. Whether you are a startup requiring short-term RA/QA expertise or an established company facing project overload, Oriel STAT A MATRIX can provide the necessary support to ensure seamless compliance and market access.
Website:
orielstat.com
HQ:
Washington, US
Jurisdictions:
EU, US
Countries:
US, DE, FR, NL, BE
Languages:
English
Response SLA:
48 hours
Onboarding time:
6–17 days
Pricing model:
Per project
Starting from:
USD 950
Role Coverage:
Importer
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Comply Guru (EU MDR Requirements Training)
Comply Guru offers globally recognized, flexible training for ISO Standards, Auditing, and Medical Device Regulations, including EU MDR and FDA QMSR. Trusted by leading organizations and Notified Bodies.
Comply Guru specializes in transformational training for MedTech QA/RA, simplifying complex international standards and regulations. They offer globally recognized credentials in various formats (online, face-to-face, blended) for ISO 13485, ISO 9001, EU MDR, EU IVDR, MDSAP, FDA QMSR, and more. Founded in 2019 to address the need for accessible and flexible learning solutions, Comply Guru is trusted by Competent Authorities, Notified Bodies, Registrars, Consultants, and Global Brands. Their mission is to make essential training more dynamic, scalable, and convenient for the modern workforce. Comply Guru is committed to GDPR compliance in its data processing for learner administration and educational obligations.
Website:
complyguru.com
HQ:
Limerick, Ireland
Jurisdictions:
EU
Countries:
US, DE, FR, GB
Languages:
English
Response SLA:
48 hours
Onboarding time:
3–17 days
Pricing model:
Per project
Starting from:
USD 400
Role Coverage:
Both
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Quality Support Group (EU MDR Course)
Quality Support Group offers expert consulting and training in quality management systems, process improvement, and supply chain management. They specialize in helping businesses secure training grants and achieve compliance with international standards.
Quality Support Group (QSG) is a global leader in providing specialized consulting and training services focused on enhancing business operations and quality management. They offer expertise in Process Improvement, Quality & Environmental Management Systems, Supply Chain Management, and Business and Operations Performance Enhancement. QSG excels in assisting organizations with implementing and integrating various Management System Standards, including ISO 9001:2015, IATF 16949:2016, ISO 14001:2026, ISO/IEC 42001, ISO 45001:2018, and ISO/IEC 17025:2017, among others. They also provide support for industry-specific standards like AS9145 for the aerospace sector. A significant area of QSG's service offering is their expertise in securing training grants for companies. They have a proven track record of helping clients obtain millions of dollars in funding for employee training through various state and federal programs, including the Massachusetts Workforce Training Fund. QSG provides comprehensive support, from identifying grant opportunities to assisting with the application process and delivering the funded training. Their consulting approach focuses on building internal capacity for sustained improvements, while their training programs are designed to be internationally accredited and industry-recognized, aiming for real business improvement. QSG's commitment to a "one-stop shopping" experience ensures clients can address a wide array of training and consulting needs efficiently.
Website:
qualitysupportgroup.com
HQ:
Boston, US
Jurisdictions:
EU
Countries:
IE, GB, DE, FR
Languages:
English
Response SLA:
24 hours
Onboarding time:
4–18 days
Pricing model:
Per project
Starting from:
EUR 600
Role Coverage:
Both
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The FDA Group (EU MDR/IVDR Compliance Support)
The FDA Group provides specialized RA/QA consulting and staffing for life science organizations, ensuring compliance and accelerating product development with expert practitioners.
The FDA Group offers specialized consulting and staffing services for life science organizations navigating complex regulatory landscapes. They provide access to experienced RA/QA subject matter experts who manage critical quality, regulatory, and clinical work with full accountability, supporting every stage from clinical development to commercialization. Their proprietary matching process connects clients with contracted SMEs who possess the exact skills needed for high-level strategy or hands-on execution. These experts integrate quickly, work autonomously, and are backed by a project management team and performance guarantee, ensuring measurable results and confidence in moving critical projects forward. The FDA Group's model combines the strategic insight of consultants with the practical execution of contractors. Their embedded SMEs are situationally deployed to achieve defined outcomes, supported by internal oversight, QA infrastructure, and a Total Quality Guarantee. They specialize in GMP, GLP, GCP, and GCLP auditing services, helping clients ensure manufacturing excellence, laboratory data integrity, clinical trial compliance, and overall adherence to industry regulations. With a focus on life science, The FDA Group helps companies address compliance gaps, prepare for FDA inspections, qualify suppliers, and maintain operational advantages through rigorous quality oversight led by industry veterans and former FDA investigators.
Website:
thefdagroup.com
HQ:
Westborough, US
Jurisdictions:
EU, US
Countries:
US, DE, FR, NL, BE, ES, IT
Languages:
English
Response SLA:
72 hours
Onboarding time:
5–22 days
Pricing model:
Retainer
Starting from:
USD 5,000
Role Coverage:
Importer
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i3CGlobal (ISO 13485 SOP Templates)
i3CGlobal offers expert medical device regulatory consulting, specializing in MDR/IVDR compliance, CE marking, and technical documentation. They ensure efficient project delivery and data security.
i3CGlobal is a trusted regulatory consulting company and a sustainable partner for medical device manufacturers. They specialize in navigating the complexities of regulatory documentation and registrations with authorities, offering expert services for EU MDR/IVDR, FDA, drugs, food supplements, and cosmetics. With a dedicated team of full-time regulatory experts, i3CGlobal ensures prompt and efficient project commencement and on-time delivery. They are committed to fair and transparent pricing, attracting a global clientele. Their services include comprehensive support for CE Marking, technical file creation, clinical evaluations, risk management, and appointing European Authorized Representatives. Data security is paramount, with ISO 27001 certification ensuring the confidentiality and integrity of client information. i3CGlobal operates 24/7, delivering documents securely via the cloud, providing a reliable and secure regulatory consulting service. They are particularly adept at assisting startups with new medical software and ensuring compliance for importing and marketing devices in Europe.
Website:
i3cglobal.com
HQ:
Bengaluru, India
Jurisdictions:
EU, US
Countries:
IN, DE, FR, US
Languages:
English
Response SLA:
72 hours
Onboarding time:
6–18 days
Pricing model:
Per SKU
Starting from:
USD 500
Role Coverage:
Both
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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
Role Coverage:
Both
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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
Role Coverage:
Both
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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
Role Coverage:
Both
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Comprehensive Buyer's Guide
1. Who Needs Importer & Distributor Compliance Support?
Companies acting as importers or distributors of medical devices in the EU, UK, or US need to understand and fulfill their regulatory obligations.
This requirement applies to:
- Importers placing devices from third countries on the EU/UK market
- Distributors making devices available on the EU/UK/US market
- Companies handling multiple device types needing comprehensive compliance processes
- New importers/distributors entering the medical device market
Note: Importer and distributor obligations are distinct from authorized representative roles. Each role has specific requirements under EU MDR, UK regulations, and other frameworks.
2. What Services Are Typically Included?
Importer/distributor compliance support typically includes:
- Compliance assessments: Evaluating your processes against regulatory requirements
- Documentation support: Developing SOPs, procedures, and templates
- Training programs: Educating your team on importer/distributor obligations
- Process development: Establishing processes for verification, storage, complaint handling
- Audit support: Preparing for and supporting regulatory audits
- Ongoing support: Consulting, process improvements, regulatory updates
3. What Affects Pricing?
Compliance support pricing varies based on:
- Number of jurisdictions: EU, UK, US—each may require separate support
- Portfolio size: Number of devices and complexity
- Service scope: One-time readiness vs. ongoing support
- Deliverables: Documentation, training, audit support, etc.
- Team size: Number of people to train
- Contract terms: Project fees vs. ongoing retainer
4. How to Choose a Provider
Key factors to consider:
- Jurisdiction expertise: Verify support for all jurisdictions you need (EU, UK, US)
- Deliverables: Confirm what's included (SOPs, templates, training, audit support)
- Experience: Check references and case studies with importers/distributors
- Training options: Assess training formats (live, recorded, on-site)
- Ongoing support: Evaluate update support and ongoing consulting options
- Pricing transparency: Request detailed breakdowns of all fees
- Industry fit: Verify experience with your device types and industry
Frequently Asked Questions
Q1: What kinds of importer/distributor compliance help are common?
Importer and distributor compliance support providers typically offer services to help companies understand and fulfill their regulatory obligations under EU MDR, UK regulations, and other frameworks. Common services include: compliance assessments (evaluating your current processes against regulatory requirements), documentation support (developing SOPs, procedures, and documentation templates for importer/distributor obligations), training programs (educating your team on importer/distributor requirements, complaint handling, traceability, etc.), process development (helping establish processes for device verification, storage, handling, complaint management, etc.), audit support (preparing for regulatory audits, supporting during audits), ongoing compliance support (ongoing consulting, process improvements, regulatory updates), and readiness packages (comprehensive one-time packages to get you compliant). The specific services vary by provider and your needs. Some providers focus on EU MDR, others on UK regulations, and some offer multi-jurisdiction support. When evaluating providers, clarify which jurisdictions they support and what specific deliverables are included.
Q2: Is importer/distributor compliance support different from authorized representative services?
Yes, these are completely distinct roles with different obligations. An authorized representative (EC REP/UKRP) is a regulatory role required for non-EU/UK manufacturers to place devices on the market. An importer is a company that places a device from a third country on the EU/UK market, and a distributor is a company that makes a device available on the market. Importers and distributors have their own compliance obligations under EU MDR/UK regulations, including: verifying devices have proper CE/UKCA marking and documentation, ensuring devices are stored and transported correctly, maintaining records of devices supplied, handling complaints and reporting incidents, and ensuring traceability. These obligations are separate from authorized representative responsibilities. A company can be an importer, distributor, authorized representative, or any combination, and each role has distinct requirements. Importer/distributor compliance support helps you fulfill your obligations in those specific roles, while authorized representative services are for the regulatory representation role.
Q3: What affects importer/distributor compliance support pricing?
Pricing for importer/distributor compliance support varies based on several factors: number of jurisdictions (EU, UK, US—each has different requirements and may require separate support), portfolio size (number of devices, device families, complexity), service scope (one-time readiness package vs. ongoing support, basic documentation vs. comprehensive process development), deliverables included (SOPs, templates, training, audit support, etc.), team size (if training multiple team members, this may affect pricing), and contract terms (one-time project fees vs. ongoing retainer). Some providers offer: basic documentation packages (SOPs and templates) for a few thousand euros, comprehensive readiness packages (full compliance assessment, documentation, training) for €10,000-€50,000+, and ongoing support retainers (monthly/annual fees for ongoing consulting and updates). Request detailed quotes that break down deliverables and pricing. Also clarify what's included vs. what requires additional fees (e.g., additional training sessions, extra documentation, audit support).
Q4: What documents should I prepare for importer/distributor compliance support?
To help providers assess your needs and develop appropriate compliance support, prepare: product portfolio information (list of devices you import/distribute, device classifications, manufacturers), current processes (existing SOPs, procedures, workflows for handling devices), supply chain details (manufacturers, suppliers, distribution channels), labeling and documentation (examples of device labeling, IFUs, certificates you receive), complaint handling processes (how you currently handle complaints, incident reporting), traceability systems (how you track devices, batch/lot tracking, recall procedures), quality management system (if you have a QMS, relevant procedures), and regulatory registrations (any existing registrations, EUDAMED actor registrations, etc.). The provider may also request: organizational charts, site information (warehouses, distribution centers), and access to your systems for assessment. More complete information helps providers tailor their support to your specific situation and identify gaps more efficiently.
Q5: How do I compare importer/distributor compliance support providers?
When comparing providers, evaluate: jurisdiction expertise (which jurisdictions they support—EU, UK, US—and depth of knowledge in each), deliverables (what's included in their packages—SOPs, templates, training, audit support, etc.), experience (how many importer/distributor clients they've worked with, case studies, references), approach (one-time packages vs. ongoing support, training-focused vs. documentation-focused), response times (SLA for support requests, turnaround times for deliverables), update support (how they handle regulatory updates, ongoing compliance changes), and pricing transparency (clear fee structures, what's included, what's additional). Also consider: whether they offer training (live, recorded, or both), if they provide templates and tools you can customize, their understanding of your industry and device types, and their ability to scale support as your business grows. Some providers specialize in specific industries or device types, which can be valuable if you have specialized needs.
Q6: What are the key importer obligations under EU MDR?
Under EU MDR, importers have specific obligations including: verifying the device has proper CE marking and declaration of conformity, ensuring the device is accompanied by required documentation (IFU, labeling, etc.), verifying the manufacturer and authorized representative are identified on the device, ensuring storage and transport conditions are maintained, maintaining records of devices imported (including batch/lot numbers, quantities, dates), verifying the UDI is assigned and appears on the device/labeling, keeping a register of complaints and incidents, reporting serious incidents and field safety corrective actions to competent authorities, cooperating with competent authorities on corrective actions, and ensuring devices are only made available if they comply with MDR requirements. Importers must also register in EUDAMED and obtain an SRN. These obligations require proper processes, documentation, and training. Importer compliance support helps you establish and maintain these processes.
Q7: What are the key distributor obligations under EU MDR?
Under EU MDR, distributors have obligations including: verifying the device has proper CE marking, ensuring the device is accompanied by required documentation, verifying the manufacturer, authorized representative, and importer (if applicable) are identified, ensuring storage and transport conditions are maintained, not making devices available if they suspect non-compliance, keeping a register of complaints and incidents, forwarding complaints and incidents to the manufacturer/importer/authorized representative, and cooperating with competent authorities. Distributors must also register in EUDAMED and obtain an SRN. While distributor obligations are generally less extensive than importer obligations, they still require proper processes and documentation. Distributor compliance support helps you understand and fulfill these requirements, especially if you're handling multiple device types or large volumes.
Provider Comparison Table
| Provider | Role | Languages | Response SLA | |
|---|---|---|---|---|
| TÜV SÜD | EU | Both | English, German | 48h |
| BSI | EU, UK | Both | English | 24h |
| SGS (MedTech Training) | EU, UK | Both | English, French | 24h |
| Intertek | EU, UK | Both | English | 24h |
| Emergo by UL (Importer/Distributor MDR Webinar) | EU | Both | English | 72h |
| MedEnvoy (Regulatory Importer Services) | EU, UK | Importer | English | 24h |
| MedNet EC-REP (Regulatory Importer) | EU | Importer | English, German | 48h |
| Specculo (EU Regulatory Importer) | EU | Importer | English, French | 48h |
| Kinesis Medical (EU Importer + 3PL) | EU | Importer | English, Dutch | 48h |
| GrowthMedics (Regulatory Importing MDR/IVDR) | EU, UK | Both | English | 72h |
Sources & Official Guidance
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MDR (Regulation (EU) 2017/745) — obligations for importers and distributors
Primary legal framework for economic operator obligations under MDR.
Last Updated: 2026-02-03
Reviewed by: Cruxi Regulatory Affairs Team
