Supervision of medical device business operation in China will be strengthened when the new regulatory measures come into effect on May 1, 2022.
On March 22, 2022, the National Medical Products Administration (NMPA) published (No.54-2022) the amended version of the Administrative Measures for the Supervision of Medical Device Business Operation to replace the previous CFDA Order No.8 announced on July 30, 2014.
Supervision of Medical Device Business Operation – Highlights
The key points about which medical device manufacturers should be aware have been summarised by our regulatory experts below.
- Business license and some other supporting materials will no longer be required in the application of obtaining business operation approval. The dossier submission and on-site inspection can be carried out once if the same applicant applies for class III medical device business operation approval and the filing of class II medical device business operation at the same time. If the class III medical device business operation approval has already been obtained, the submission of the corresponding information for the filing of class II medical device can be exempted.
- The internal review for business operation approvals will be reduced from 30 working days to 20 working days.
- The NMPA announced a list of 13 class II medical devices that will be exempted from business operation filing as the effectiveness and safety of the product won’t be affected by the distribution process. Medical device registrants or filers that are selling the products in their own residential address or manufacturing sites, as well as non-profit organizations handling the storage, distribution, and supply of contraceptive medical devices will all be exempted from business operation filing.
- Public statement declaring the loss of the business operation approval certificate will no longer be required to apply for a new certificate.
On March 22, 2022, the NMPA published (No.53-2022) the amended version of the Administrative Measures for the Supervision of Medical Device Manufacturing to replace the previous CFDA Order No.7 announced on July 30, 2014. Read our separate blog post for more information.
By Julie Zhang and Jacky Li. If you would like to learn more about supervision of medical device business operations in China or our registration and CRO services for medical devices, IVDs, pharmaceuticals, cosmetics or other products, please contact Cisema.