Legal representative

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

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

Acting legal representative in diverse markets
Being outsourced to support legal representative tasks of reliable distributor
Inspecting your legal representative upon local requirements plus your in-house supplier management
Controlling your legal representative in our KPI-workshops or e-learning of regulatory affairs
Customer tailored template in terms of working with international partner (change notification and vigilance form)