On July 19, 2021, the NMPA (National Medical Products Administration) published a regulatory draft to solicit public comments on its proposal to require all class III medical devices and IVDs manufactured after March 1, 2022 to have unique device identifiers (UDI). This proposal follows a pilot plan implemented earlier this year requiring only that high-risk class III medical devices have UDIs.
Highlights
Following the implementation of the UDI for the first batch of products, the NMPA suggests the following:
- For the second batch of medical devices manufactured after March 1, 2022, these are required to have their own UDI, however, the UDI will not be required for medical devices manufactured before March 1, 2022, subject to the manufacturing date indicated on the label.
- The UDI of the product’s smallest (innermost) packaging unit should be submitted to the UDI registration system from March 1, 2022, onwards.
- For the second batch of medical devices manufactured after March 1, 2022, the UDI of the product’s smallest (innermost) packaging unit should be uploaded to the UDI database already before selling into the market.
The public consultation is currently open until August 16, 2021.
By Jacky Li and Colleen Xu. Contact Cisema if you would like to learn more.
