Overview
The domestic legal China agent, appointed by the registrant of the imported medical device, is required to submit a self-inspection report to the Provincial Regulatory Authority in their location. This report must include:
- 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 centralized purchasing
- Internal audit and management review
If the legal China agent represents multiple registrants of imported medical devices, the self-inspection report must encompass all products from these registrants, with certain sections completed separately as required.
Submission Timeline
The annual self-inspection report of the quality management system should include statistical data covering January 1st to December 31st of the previous year. This report must be submitted to the regulatory authorities by March 31 of the current year.
Attachment
Guidelines for the preparation of annual self-inspection reports for medical devices quality management system.