【Deadline】 2021 Annual Quality System Self-Inspection Report To China NMPA
2022-01-18
Dear Medical Device Manufacturers,
Here is a kind REMINDER to manufacturers operating Class III medical devices in China, your deadline for submitting the 2021 Annual Quality System Self-Inspection Report to China’s provincial level NMPA is January 31st, 2022. Failure to report may possibly lead to the consequences of warning letter, fines, production suspension, even revocation of medical device registration certificate.
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
Unique Identification of Medical Devices (UDI)
Let us know if you need more guidance or have any questions about the annual report submission.
