The domestic legal China agent appointed by the registrant of the imported medical device shall submit a self-inspection report to the Provincial Regulatory Authority where the legal agent is located. This shall include, among other things, imported medical devices, major changes that have occurred during the year, sales and post-marketing surveillance in China, adverse event monitoring, re-evaluation, inspection, procurement system for the centralized purchasing, as well as internal audit and management review. If the legal China agent represents multiple different registrants of imported medical devices as legal agent, the self-inspection report shall include all the products of all the registrants of imported medical devices the entity represents, and some contents shall be filled in separately as required.
The annual self-inspection report of quality management system shall be filled in with the statistical data from January 1st to December 31st of the previous year and shall be submitted to the regulatory authorities before March 31 of the current year.
Attachment: Guidelines for the preparation of annual self-inspection reports of the medical device quality management system.