Why you need to appoint a china Legal Agent?
According to China State Order No. 739, a foreign medical device registration applicant have to appoint a Chinese company as its legal Agent in China. The legal Agent shall contact NMPA on behalf of the foreign medical device registration applicant, assist in product registration, and be responsible for the tracking of products after marketing and the reporting of adverse events.
Many foreign registration applicants prefer to find a professional medical device regulatory consulting company as the legal agent, so as to better complete the regulatory registration, post marketing quality tracking and other responsibilities.
What are the responsibilities of china Legal Agent?
Article 20 of Chapter II of China State Order No. 739 “Regulations on the Supervision and Administration of Medical Devices” described the responsibilities of China Legal Agent as below:
lTo assist overseas medical device registrant to set up the quality management system suitable for the product and maintain the effective operation；
lTo assist overseas medical device registrant to establish post-market research and risk control plan and ensure effective implementation；
lTo assist overseas medical device registrant to monitor and report the adverse events of imported medical devices sold in China, and report the adverse events of medical devices abroad to NMPA in time according to the regulations；
lTo assistoverseas medical device registrant with the recall of medical devices after marketing, quality tracking and report to NMPA; and
lTo assist overseas medical device registrant in fulfilling other obligations stipulated by the drug and device regulatory department under the State Council.
For medical devices, China Legal Agent must be a company registered in China mainland.
In addition, all the NMPA registration documents must be signed and stamped by China Legal Agent. This is why appointing a professional regulatory firm that you can depend on to represent your interests is important.
