On February 17, 2023, the NMPA in China made an announcement on the implementation of the 3rd Unique Device Identification (UDI) of medical devices.
Depending on the degree of risk and regulatory needs, some Class2 medical devices, such as disposable products with high clinical demand, products selected for mass supply, and medical beauty-related products, are determined to be in the third batch.
For medical devices included in the third batch, the following tasks must be performed.
1. UDI code issuance
The manufacturing date is based on the medical device label. Medical devices produced from June 1, 2024 must have a medical device unique identification, and a third product that implements a previously produced unique identification does not require unique identification.
2. Submission of a unique identification registration system
When applying for registration from June 1, 2024, registration applicants must submit a product ID for the minimum sales unit of the product in the registration management system. If an application for registration is received or approved before June 1, 2024, the registrant must renew the product registration in the product registration management system, and if the registration is changed, the registration management system must submit the product identification number for the minimum sales unit of the product.
3. Submit a unique identification database
For medical devices produced from June 1, 2024, before being placed on the market for sale, registrants will be required to upload data related to the minimum sales unit and packaging to the Medical Device Unique Identification Database.
The items included in the 3rd batch are briefly listed below.
| 01 | Active surgical instruments |
| 02 | Non-active surgical instruments |
| 03 | Neurological and cardiovascular surgical devices |
| 04 | Orthopedic surgical equipment |
| 06 | Medical imaging equipment |
| 07 | Medical diagnostic and monitoring equipment |
| 08 | Respiratory, anesthesia and first aid equipment |
| 09 | Phototherapy equipment |
| 10 | Blood transfusion, dialysis and extracorporeal circulation equipment |
| 12 | Active implantable device |
| 14 | Infusion, Nursing and Protective Equipment (PPE) |
| 16 | Ophthalmic devices |
| 18 | Obstetrics and gynecology, assisted reproduction and contraceptive devices |
| 19 | Medical rehabilitation equipment |
| 22 | Clinical laboratory equipment |
Please refer to the attached file for detailed items.
Please meet the UDI standard by June 1, 2024 for products corresponding to the implementation of the 3rd batch.
If you have any questions about medical device,
Please contact us with the below.
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