China UDI requirements will cover various class II medical devices manufactured after June 1, 2024, upon the implementation of the finalized regulation.
On November 30, 2022, the National Medical Products Administration (NMPA) released a draft for comments for the third batch of medical devices requiring UDI. The third batch containing class II products has been determined by NMPA depending on the “degree of risk and regulatory needs” and includes:
• Various active & passive surgical instruments
• Instruments for neurological and cardiovascular surgery
• Medical imaging equipment
• Medical examination and monitoring equipment
• Respiration, anesthesia and first aid equipment
• Ophthalmic instruments
• Physical therapy equipment
• Obstetrics and gynecology, assisted reproduction and contraceptives products
• Medical rehabilitation equipment
• Clinical testing instruments
The full list is in the annex to the draft announcement (link below).
UDI code
- Medical devices manufactured on or after June 1, 2024, shall have a Unique Device Identification (UDI) code.
- Medical devices manufactured before June 1, 2024, can still be sold to the market without the UDI code.
The production date is subject to the medical device label.
Submission to the UDI registration management system
- If the applicant applies for registration on or after June 1, 2024, the applicant shall submit the identification code of the product’s smallest sales unit to the registration management system.
- If the registration has been accepted or approved before June 1, 2024, the registrant shall submit the identification code of the product’s smallest sales unit to the registration management system for any registration renewal or product change applications.
UDI codes are not part of the review items for NMPA registration approvals, hence individual UDI changes do not fall under the scope of product changes.
Submission to the UDI database
- For medical devices manufactured from June 1, 2024, onwards, the registrant shall upload the identification code of the product’s smallest sales unit and higher-level packaging, as well as related data to the UDI database before selling the product to the market.
- When there are related data changes to the UDI of the product’s smallest sales unit, the registrant shall keep the information in the UDI database up-to-date before selling the product to the market.
Further information
If you would like to learn more about the China UDI requirements or how we can support you to comply with the regulatory requirements for selling medical devices in China, please contact us.
