Annual QMS self-inspection reports have new filing instructions and new report submission requirements for importing products currently in draft.
On November 15, 2021, the NMPA (National Medical Products Administration) issued the draft guidelines for writing the annual report for the QMS (Quality Management System) of medical devices. The NMPA intends to replace the current version of the guideline (No.76 – 2016) that was issued on April 28, 2016.
- Registrants, filers, and entrusted manufacturers shall carry out the annual self-inspection according to the China GMP requirements, and prepare the annual self-inspection report on the QMS for submission.
- The annual self-inspection report should include the following items:
- An overview of the production and quality performance review
- Significant annual changes including the change of product design, the change of production and inspection area, the change of production and inspection equipment, the change of production process and the change of important suppliers
- An overview of the QMS operation
- An overview of compliance review, supervision or inspection carried out by the respective MPAs, as well as any major issues identified and the respective follow up actions
- NMPA legal agents of importing medical devices should submit the self-inspection report on behalf of the registrants and filers to the provincial MPA along with the information on sales, post-market management, adverse event monitoring, inspection, etc.
This change will increase the documentary requirements and effort for NMPA submission of medical device & IVD. If you would like to understand how for your specific product, we can review and feedback following your request. Please also ask about our China QMS/GMP checking and gap analysis services.
By Alice Liu and Jacky Li. Contact Cisema if you would like to learn more.