China Legal Agents of Medical Device

In accordance with the China medical device regulations, any companies without offices in China are required to appoint a local registered legal entity to act as China Legal Agent (in-country regulatory representative) of medical device in China.

Related regulations

The Regulations for the Supervision and Administration of Medical Devices (Decree No. 650 2014)

(Article 10) Class I medical devices manufacturing enterprise abroad which plan to export to china, shall submit the record data and related documents which are approved by the medical device competent departments of overseas governments to prove that the product can enter a certain country (or region) to food and drug administration department under the State Council via its representative offices established within Chinese territory or appointed agent which is the enterprise legal person within Chinese territory.
(Article 11) Class II, class III medical devices manufacturing enterprise abroad which plan to export to china, shall submit the record data and related documents which are approved by the medical device competent departments of overseas governments to prove that the product can enter a certain country (or region) to food and drug administration department under the State Council via its representative offices established within Chinese territory or appointed agent which is the enterprise legal person within Chinese territory.

Administrative Measures for Medical Device Registration (CFDA Order No. 4 2014)
Administrative Measures for the Registration of In Vitro Diagnostic Reagents (CFDA Order No. 5 2014)

The Obligations of Foreign Manufacturers’ Authorized Representatives (Legal Agent)
The foreign manufacturer via its designated China Legal Agent to apply for the medical device registration or filing, and its China Legal Agent shall bear the following responsibility:
a) Contact with the corresponding food and drug administration department and the foreign applicants (or proposer).
b) Convey the regulations and technical requirements to the foreign applicants (or proposer) accurately and precisely
c) Collect adverse events of the post-marketing medical devices and feed back to the foreign applicants (or proposer), and report it to the corresponding food and drug administration department.
d) Recall the post-marketing medical device which has quality matters and report to the corresponding food and drug administration department.
e) Other responsibilities related to product quality and after-sale service.　
　
Who Are Qualified to Act as China Legal Agent of Medical Device?
The China Legal Agents of medical device must have a valid business registration, full range service and located in China. And they have sufficient background in the practical handing of regulatory affairs of medical device in China. The China Legal Agent may be the following agents:

China subsidiary or branch office
Designated an legal entity registered in China
The sales agents in China
The registration service agent (CIRS China)

How to Appoint a China Legal Agent of Medical Device?

The format of Power of Attorney can be found here.

How to Change your China Legal Agent of Medical Device?
It will be required to apply for Medical Device Registration Certificate Change from CFDA when China Legal Agent changed, and it is not administrative approval under medical device regulations.

The data required for China Legal Agent Change Application
a) Application form
b) Supporting documents

Instruction of the modification do not need to be approved by oversea supervision department
Power of attorney of China appointed agent
Letter of agent commitment
Business certificate of agent (photocopy)

c) Conformity of modification
d) Medical device registration certificate and attachments, all previous modification documents of medical device registration certification (photocopy)

Medical device registration certificate and attachments (photocopy)
All previous modification document of medical device registration certification (photocopy)

e) Dossier requirements of modification application project

New business certificate of the agent
Old business certificate of the agent

f) Conformity declarations

Declaration of register confirm that the product conform to and relevant requirement of regulation. Declaration of the product conform to current China national standards, industry standards, and issue the list of conformity standards
Declaration of authenticity of applicant document (applicant)
Declaration of authenticity of applicant document (agent)

g) Notarized documents provide by oversea medical device manufacturer
Please note that the information of China Legal Agent will be indicated on the Medical Device Registration Certificate, Chinese Label and Chinese Product Instructions.
CIRS is a professional and independent Firm with a sufficient background in the practical handling of regulatory affairs of medical device in China. If you have any needs and questions about the medical device regulatory affairs, please contact us at md@cirs-group.com.

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