In-Country Representation Services
Your Local Regulatory Partner in Global Markets.
Most global regulatory agencies won’t let you market medical devices and IVD products without local representation in their jurisdiction. Your in-country representative becomes the official link between your company and regulatory authorities, managing compliance requirements, post-market surveillance, and adverse event reporting throughout your product’s lifecycle.
AJW Technology Consultants provides in-country representation services across major global markets. Through our subsidiary offices in the United States, European Union, United Kingdom, Switzerland, Australia, and New Zealand, we serve as your local regulatory partner, handling the legal obligations that keep your products compliant.
Why In-Country Representation Matters
Regulatory authorities need a local entity they can contact immediately when issues arise, whether that’s a safety concern, an inspection, a product recall, or routine correspondence. Your in-country representative:
- Serves as the official point of contact with regulatory authorities
- Coordinates post-market surveillance and vigilance reporting
- Maintains regulatory correspondence and documentation
- Responds to authority inquiries and inspections
- Handles adverse event notifications and recalls
- Manages device registrations and listings
Without proper in-country representation, you cannot legally market your products in most jurisdictions.
United States
US Agent Services
Foreign medical device and pharmaceutical manufacturers must designate a US Agent under FDA regulations. The US Agent communicates with the FDA, receives correspondence, and assists with registration requirements. From our Tampa Bay headquarters, our team provides:
- FDA establishment registration and device listing
- Official correspondent services for FDA communications
- Support for medical devices (all classifications) and pharmaceutical products
- Compliance support for US regulatory requirements
As your US Agent, we ensure the FDA can reach you promptly when needed while helping you handle ongoing compliance obligations in the US market.
European Union
Authorized Representative Services
EU MDR and IVDR require non-EU manufacturers to appoint an Authorized Representative (AR) within the EU. Your AR acts as legal representative for regulatory matters. From our Düsseldorf office, our experts provide:
- CE marking technical documentation support
- Post-market surveillance and vigilance coordination
- Competent authority correspondence
- EU device registration (EUDAMED when fully operational)
- Support for medical device manufacturers (EU MDR 2017/745) and IVD manufacturers (EU IVDR 2017/746)
In addition to AR services, we can provide or coordinate EU importer designation, which is required under MDR and IVDR for products entering the EU market.
United Kingdom
UK Responsible Person Services
Following Brexit, UK regulations require manufacturers to appoint a UK Responsible Person (UKRP). Manufacturers need both EU AR and UK RP for both markets. Our London office provides:
- Official correspondent services with MHRA
- UKRP appointment for UKCA marking and legacy CE-marked devices
- MHRA device registration under UK medical device regulations
- Post-market surveillance and vigilance reporting
- Compliance support for UK-specific requirements
Similar to EU requirements, the UK also requires Importer designation for products entering the UK market. We can provide or coordinate UK Importer services to ensure compliance with MHRA regulations.
Switzerland
Authorized Representative Services
Since May 26, 2021, Switzerland requires in-country Authorized Representatives. Switzerland no longer recognizes outside representatives, making local presence mandatory. Our Zurich office (Germany branch) provides:
- Swiss Authorized Representative (AR) appointment for all device classifications
- SwissMedic product registration (for applicable device categories)
- Swiss vigilance reporting and post-market compliance
- Regulatory correspondence with SwissMedic
Switzerland also requires Importer designation for products entering the Swiss market. Our Zurich office can provide Swiss Importer services alongside AR representation.
Learn more about our import services →
Australia and New Zealand
Sponsor Services
Australia and New Zealand require a local “Sponsor” with legal responsibility for products. The Sponsor role involves direct accountability for device safety and compliance. Our offices provide:
- Medsafe submissions in New Zealand
- TGA (Therapeutic Goods Administration) submissions in Australia
- Device registration and ARTG/WAND database listings
- Post-market surveillance and adverse event reporting
- Recall coordination and regulatory correspondence
- Legal accountability as the responsible entity in-market
The Sponsor serves as the liaison between regulatory authorities and manufacturers, with heightened visibility and collaboration with TGA and Medsafe on all compliance matters.
Additional Markets: Strategic Partner Network
While our direct offices cover major regulated markets, we maintain strategic partnerships for in-country representation in Latin America (including Brazil), India, Asia, Middle East, Africa, and more. When you’re ready to expand into these markets, we can introduce you to qualified local partners in our referral network.
Why Choose AJW for In-Country Representation
Most manufacturers need representation across multiple markets. Working with a single partner across the US, EU, UK, Switzerland, Australia, and New Zealand simplifies compliance management and ensures consistent communication. We’re your regulatory affairs team, not just a paperwork provider. We understand your products and regulatory strategy.