International Legal representative 

Background


This article is dedicated for foreign manufacturer in subject market where no legal representative exists.


Authorised legal representative of medical device is a legal person in most markets who in behalf of legal manufacturer to register medical device to authority or represent foreign manufacturer. It is also called legal agent, responsible person, marketing authorised holder or sponsor.

 

Comparison of legal representative


Here below we compare the legal representative in Europe, China and Swiss. It is called as Chinese agent, EU rep, CH rep.


 

Comparison item EU rep Chinese agent CH rep
Regulation MDR, article 10 Regulations on the Supervision and Administration of Medical Devices , article 20 Art. 51 para. 2 MedDO
Role Check conformity and TD, Coordination of CAPA and vigilance Coordination of product deficiency at registration, inform vigilance, assistance of the potential inspection by authority Check conformity and TD, Coordination of CAPA and vigilance
Liability Very high high Very high
Related to product registration No Submit TD No
Registration In EUDAMED no In Swissdamed
On Certificate No yes No
On labelling no yes yes
PMS report Submit SCCP Coordination and submit TBD
Termination Easy Medium, need administrative change registration Easy
Speciality Need Person Responsible for Regulatory Compliance Register all country specific report and codes (UDI, issuance) Need Person Responsible for Regulatory Compliance
Trend More regulatory demanding More liability, more frequency to be inspected Aligning EU rep and UK responsible person


  1. Common characteristic


All three roles in EU, China and Swiss have binding regulation and liability. It is necessary to have Chinese agent, EU- and CH rep to coordinate vigilance for foreign manufacturers. The users of medical device can find information of legal persons in 3 markets on product labelling.


2. Similar items


The responsibility of three legal representatives is more or less the same as liaison between manufacturers to authority.


3. Special as representative


Chinese agent is unique to submit technical documentation to Chinese authority. Although EU- and CH rep has never involved at product registration, they have to verify declaration of conformity and technical documentation. They need special Person Responsible for Regulatory Compliance knowing regulatory issues. Besides EU- and CH rep have to register themselves at central database. 



Outlook


We can offer legal manufacturer of medical device for