We’re Your Local
Representative
For medical devices and in vitro diagnostic devices (IVDs), many regulatory frameworks worldwide require manufacturers that are not established in the country where they intend to sell their products to appoint a local in-country representative. We act as your representative and your primary point of contact with local authorities to ensure smooth communications and continuous regulatory compliance.
Global Representation through One Relationship
Across major markets — including Europe, the United Kingdom, Switzerland, Australia, China, the United States, Saudi Arabia, India, Korea, South America, and Southeast Asia — local representation is often a legal requirement for market access.
With a single global partner managing your representation requirements, you benefit from:
- Aligned regulatory strategies
- Consistent documentation control
- Simplified communication across all markets
Registrar Corp and CMC Medical Devices are trusted worldwide for our expertise, efficiency, and follow-through. We can act as your local representation and provide all required services to maintain compliance in the following regions:
Europe: European Authorized Representative (EC REP)
We serve as your mandatory European representative for medical devices and in-vitro diagnostic devices. Comply with MDR European Medical Device Regulations (EU 2017/745) and ongoing EUDAMED registration and file updates.
United Kingdom:
UK Responsible Person (UKRP)
Since Brexit, manufacturers outside the UK, including other European countries, are required to appoint a UK-based Responsible Person for Medical Devices. As your UKRP, we register and maintain MHRA compliance and ensure strict adherence to all UK MDR 2002 requirements for medical and IVDR products.
Switzerland: Swiss Authorized Representative (CH-REP)
Switzerland is not part of the EU, and requires separate local representation for non-Swiss manufacturers. As your CH-REP, we ensure you stay compliance with all MedDO regulations and requirements. Rest assured with Registrar as your pan-European compliance partner.
China: China Medical Device Registration (NMPA)
Navigating the Chinese market can be complex. Let Registrar make it simple for you. We ensure meticulous accuracy with all National Medical Products Administration of China (NMPA) requirements.
Australia: TGA Sponsor
We serve as your required Australia sponsor, or TGA Sponsor, for medical devices and IVDs. We ensure proper registration post-market compliance while acting as your liaison with the Therapeutic Goods Administration (TGA).
United States: FDA Agent
Registrar has been the global leader for FDA compliance and U.S. market access for decades. We let you focus on your business, and we’ll take care of all FDA requirements and act as your local FDA Agent.
We also provide local authorized representation services in Saudi Arabia, India, Korea, South America, and Southeast Asia, where appointing an in-country representative is often a mandatory legal requirement to obtain and maintain market access for medical devices and IVDs.
Talk to a Registrar Compliance Expert
Secure local representation — and peace of mind — with a free
consultation how Registrar can help. Contact us today.
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