Authorized Representatives

Similar to the European Authorized Representative (EAR), there are also Chinese authorized agents and related consulting agencies in China.

The definition and responsibilities of agents for imported medical devices are clearly stated in Article 11 and Article 14 of the Regulations for the Supervision and Administration of Medical Devices. 

Regulations for the Supervision and Administration of Medical Devices" Article XI: export to the territory of China's second and third class medical device manufacturers outside China, should be established by its representative office in China or designate the enterprise legal person in China as an authorized representative. AR shall submit to the State Council Food and Drug Administration to apply for registration information and departmental permission to market and sell the medical device documents.

Medical Device Registration Management Measures" Article 14: AR is to apply to the competent department of food and drug administration of the State Council for a certificate and permission to enter the market. In addition, AR assume responsibility for product quality, joint and several liability, recall and other legal manufacturer responsibility obligations of the subject.

According to the above relevant laws and regulations, the responsibilities of the authorized representative (AR) in China provided by our company are as follows:

1. Provide compliance management services and relevant regulatory consulting services related to AR work on the premise of complying with the laws and regulations of the People's Republic of China. Timely collect, update and provide the latest information and changes of regulations and necessary legal and regulatory documents, including or newly issued national standards or industry standards.

2. Assisted in the preparation and submission of QMS,GMP and related documents, and converted relevant documents required by GMP into documents approved by NMPA in accordance with the medical device industry standards (YY/T0287, YY/T0288). Check and confirm the submission of quality management system self-inspection report and all related documents. To structure, provide templates and review medical device product risk assessment reports in accordance with NMPA requirements.

3. Report the investigation, analysis, evaluation and product risk control to the medical device adverse event monitoring technical institution in accordance with the provisions of the State drug regulatory department. Responsible for contacting with China National Food and Drug Administration and medical device regulatory agencies, assisting in handling medical device complaints, accidents, adverse events, etc. Assist in collecting relevant information and product recovery after quality problems occur. In accordance with the requirements of NMPA regulations, the information should be uploaded to the national adverse drug Reaction Testing system within the specified time.

4. Provide compliance support related to AR management system and flight inspection. When regulators raise issues, they liaise, respond, reply and communicate. To complete the post-marketing research and risk control plan of medical devices and ensure its effective implementation according to the Regulations on the Supervision and Administration of Medical Devices issued by the State Drug Administration Department.

5. Assisted in supervising the validity of the maintenance documents, presided over the convening of meetings on medical devices and products, and wrote and submitted annual reports and NMPA related reports.