China NMPA Medical Device News
Since 2021, UDI has covered all class III medical devices in China through stepwise implementations (1st and 2nd batch catalogues). On February 17th, 2023, NMPA announced the 3rd batch catalogue for the implementation of UDI on some class II medical devices in China. This 3rd batch catalogue of implementation covers the following devices:
Some disposal single use medical devices which have large clinical demand.
Selected medical devices with centralized procurement.
Medical cosmetology related products.
If you would like to know if your products fall within these categories, please contact us at firstname.lastname@example.org, +41 78 8527130. We will help you.
Schedule of implementation:
1. Use of UDI
Medical devices manufactured from June 1st, 2024 onwards, shall bear the UDI marking. Medical devices manufactured before this date do not have to bear the UDI marking. The manufacturing date is determined according to the label of the medical device.
2. Submission to the UDI registration system
For a medical device registration application dated from June 1st, 2024 onwards, the registrant shall submit the device identifier of the smallest sales unit. For registration applications submitted or approved before June 1st, 2024, registrants shall submit the device identifier of the smallest sales unit during the amendment or renewal registrations of the product. Changes to the device identifier is not regarded as an amendment to the product registration.
3. Submission to the UDI database
For medical devices manufactured from June 1st, 2024 onwards, the registrant shall submit the device identifiers of the smallest sales unit and higher level packaging to the medical device UDI database, before selling the product in the market. The same shall apply if there are changes to the device identifier of the smallest sales unit.
CETR accelerates your medical device registrations and market access in China safely, quickly and successfully.
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