Supervision of medical device manufacturing in China will be strengthened when a new regulatory measure comes into effect on May 1, 2022.
On March 22, 2022, the National Medical Products Administration (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.
China Supervision of Medical Device Manufacturing – Key Changes
The key changes about which manufacturers should be aware are summarised by our regulatory experts below.
- For the application of medical device production licenses and the filing of class I medical device production, information that can be verified online will no longer be required in the dossier submission such as the copy of the business license.
- The internal review of medical device production license approvals will be reduced from 30 working days to 20 working days.
- The filing of class I medical device production and the filing of the class I medical device itself can be applied at the same time for both applications.
- OEM (Original Entrusted Manufacture) manufacturers will be allowed to use the registrant’s certificate to apply for medical device production licenses in China. In the past, medical device production licenses can only be applied by the original manufacturers themselves with their own registration certificate.
- OEM production will no longer be restricted to one OEM manufacturer only. The “Entrusted Production Management” chapter will be removed from the new measures, but administered in the QMS requirements instead.
- OEM manufacturers and the registrants will be required to sign the OEM quality agreement specifying the obligations and responsibilities of both sides. Registrants will be responsible for the product quality and safety whilst the OEM manufacturers will be responsible for the production activities.
- The new measures also specify the responsibilities of registrants when carrying out inspection for cross-province OEM production.
On March 22, 2022, the NMPA issued 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. Read our separate blog post for more information.
On March 24, 2022, the NMPA also published the following two regulatory measures concerning OEM production in China:
- Catalogue of medical device products to be prohibited from OEM production in China (No.17-2022)
- Guideline for writing OEM quality agreements in China (No.20-2022)
By Julie Zhang and Jacky Li. If you would like to learn more about supervision of medical device manufacturing in China or our registration and CRO services for medical devices, IVDs, pharmaceuticals, cosmetics or other products, please contact Cisema.