Differences in Agent between China, US and Europe

2020-03-07

We often encounter the word “agent” when registering medical devices no matter at home or abroad. What exactly does it mean and what is required of an “agent”?

Here are the relevant requirements for medical device “agents” in Chinese, US and European regulations.

	China Legal Agent	USA U.S. Agent	European Authorized Representative
Definition	A representative entity established by an overseas manufacturer within the territory of China or an enterprise as a legal agent within the territory of China.	U.S. agent appointed by overseas manufacturers	Accept a written authorization from a manufacturer located outside the Europe to act on behalf of the manufacturer for its specific tasks under the European Medical Device Regulation (MDR).
Qualification	Legal or representative entity	Natural or legal person	Natural or legal person with special staff responsible for regulatory compliance.
Medical Device Registration	Legal agent shall submit the relevant registration / filing dossiers and then faithfully and accurately deliver relevant regulations and technical requirements to overseas manufacturers.	It is not directly related to device registration.	The representatives shall confirm that the manufacturer has a Declaration of Conformity (DoC) and technical documentation. Meanwhile, the corresponding conformity assessment procedures have been implemented. They shall keep a copy of the latest technical documentation, DoC and certificates for inspection by regulatory authority.
Daily Contact	Responsible for communication between drug/device regulatory department and overseas manufacturers	Assist FDA to communicate with overseas manufacturers, arrange inspection schedules and collect FDA documents.	Responsible for communication with regulatory authorities and overseas manufacturers, and providing relevant information and documents.
IFU	The name, address and contact information of legal agent shall be stated in the description.	No requirements	No requirements
Label	The name, domicile and contact details of legal agent should be stated.	No requirements	Information of authorized representatives (name and registered address) shall be stated.
Certificate	Legal agent information is specified in the registration of medical devices.	The agent information will be listed on the company registration information page.	The authorized representative information will appear in the CE certificate and DoC.
Recall	Coordinate product recalls and report to NMPA.	No requirements	Cooperate with regulatory authorities to take preventive or corrective action on specific devices. Work with dealers to assist with field safety corrective actions (FSCA).
AE	Collect post-market adverse event information and report to overseas manufacturers and NMPA. Cooperate with overseas manufacturers to fulfill their re-evaluation obligations.	No requirements	Once the adverse event information is collected, it shall be fed back to the overseas manufacturers immediately.
Modification Method	Modify the registry item on certificate	Modify through the FURLS system.	Modify CE certificate and DoC.
Legal Responsibility	Joint responsibility for product quality and after-sales service.	No requirements	Take several joint responsibility for the manufacturer’s liability listed in MDR Article 10.

Bradynuoen is a qualified legal agent to support overseas manufacturers during registration, clinical trial and post-market surveillance. Please do not hesitate to contact us for any help on your China business via info@inspirativemed.com.