The National Medical Products Administration (NMPA) has revised the "Quality Management Standards for the Operation of Medical Devices" to strengthen the quality management of medical device operations, standardize business practices, promote industry development, and ensure the safety and effectiveness of medical devices for the public. The revised standards will be effective on July 1, 2024, replacing the previous announcement (No. 58 of 2014) issued by the former China Food and Drug Administration (CFDA) on implementing quality management standards for the operation of medical devices.
The critical points of the revision are summarized as follows:
1. Enterprises should strengthen the quality management of automatic vending machines.
2. Enterprises should strengthen the quality management of warehouses set up across administrative regions.
3. Enterprises should strengthen the quality management of medical devices purchased and sold by direct transfer.
4. Enterprises should carry out reasonable storage according to the quality characteristics of medical devices. The "management standard" regarding in-storage storage has been revised and refined according to the actual situation of medical device products.
5. The "management standard" stipulates that enterprises engaged in the medical device wholesale business should attach the accompanying list when medical devices are out of storage and make provisions for the contents to be included.
6. The "management standard" specifies the contents that should be recorded while transporting of medical devices.
7. The "management standard" stipulates some requirements for after-sales service.
- Announcement of the NMPA on the Release of Quality Management Standards for Medical Device Operations (2023 No. 153)