China NMPA - UDI soon required for various class II products (third batch)China's NMPA has issued a draft for comments for the third batch of medical devices requiring UDI last week. This means that various class II medical devices - in addition to all class III medical devices - will be required to implement unique device identifiers if manufactured after
June 1, 2024.On January 1, 2021, the first batch of 69 varieties in 9 categories began to implement the unique identification of medical devices. These were various high-risk class III devices. On June 1, 2022, other Class III medical devices (including in vitro diagnostic reagents) were identified as the second batch.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).
Deadline for feedback is December 30, 2022 and should be sent to: mdct@nmpa.gov.cn, with the subject line indicating "UDI Third Batch Implementation" (Contact person and telephone: Dong Qian, 010-88330608).
We are also collating comments from industry and would be pleased to hear your feedback.
The official website link of the announcement can be found here: https://www.nmpa.gov.cn/directory/web/nmpa/xxgk/zhqyj/zhqyjylqx/20221130144240106.html
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Hamish King
hamish.king@cisema.comwww.cisema.com------------------------------