Medical Device
In-Country Representation

Many jurisdictions require a locally established party when the legal manufacturer is outside the market, but the trigger and role differ. EU MDR Article 11 addresses the authorized representative for a manufacturer not established in a Member State; Great Britain requires a UK Responsible Person for a manufacturer based outside the UK; FDA requires a U.S. Agent for a foreign device establishment. Other markets may require a registration holder, local applicant, sponsor, or representative. We confirm the role from the current rule and the manufacturer's establishment before appointment.

No. FDA describes the U.S. Agent as a U.S.-based liaison with limited communication and inspection-scheduling duties; the agent is not responsible for adverse-event reporting or submitting a 510(k). The EU Authorized Representative acts under a written mandate and the duties in EU MDR Article 11. The UK Responsible Person registers devices with MHRA and carries specified UK responsibilities. Contracts and workflows must reflect those differences.

We can coordinate multiple representation and registration workstreams through one global program, using Pure Global entities or qualified local partners according to the target market and agreed scope. The actual legal entity, eligible role, country coverage, fees, and responsibility matrix are confirmed before contracting. See our markets and locations for current coverage; do not assume that one entity or appointment is valid across every jurisdiction.

Not necessarily. A representative acts on behalf of the manufacturer under a legal or contractual mandate. An importer places a device from another country onto the market, and a distributor makes it available further in the supply chain. Some jurisdictions allow one organization to hold more than one role, but the obligations remain distinct. We map the role combination, labeling, registrations, complaint routing, and economic-operator responsibilities before products move.

The answer depends on local law and the registration model. Some records sit in the manufacturer's name with a representative attached; other markets require a locally eligible applicant or registration holder. The service agreement should address data access, certificates, distributor authorization, change control, renewal work, termination, and any transfer route that the authority permits. We do not promise transferability where a jurisdiction does not provide it.

The parties should first review the mandate, registrations, labeling, authority accounts, vigilance files, open incidents, renewal dates, distributor records, and any market-specific transfer process. Required notices and label changes must be sequenced so there is no gap in local coverage. A controlled handover should also preserve evidence and communication history while respecting confidentiality and the authority's rules.