NMPA Onsite Inspection On Manufacturers Or Legal Agent Without Submitting Annual Quality System Self-Inspection Report Since April 2023

For manufacturers operating medical devices in China, NMPA has issued the deadline for submitting the 2022 Annual Quality System Self-Inspection Report to China’s provincial level NMPA on March 31st, 2023.

Failure to report will lead to the consequences of warning letter, fines, production suspension, even revocation of medical device registration certificate.

For some manufacturers without submitting annual self-inspection report by March 31^st, 2023, they have received a notice from local NMPA that if not submitting self-inspection report, NMPA will do onsite inspection since April 2023.

The annual report shall contain the following aspects:

• Basic overview (date of establishment, size of the enterprise, total number of employees, main business contents)
• Changes (personnel, business site, warehouse address, business scope, etc.)
• Conduct of business activities
• Operation of GSP for medical devices
• Supervision and inspection
• Adverse events
• Internal audit and management review

Details in Announcement on Issuing the Guideline on the Preparation of Annual Self-Inspection Report on Medical Device Quality Management System (No. 13, 2022) | BradyKnows (bradyknowsmedical.com)

If you need any help on submitting annual self-inspection report, please reach out to BradyKnows via info@bradyknowsmedical.com