NMPA “Rules for Unique Device Identification (UDI) System” Issued on August 27, 2019 mandates that the China UDI system for the first group of devices will take effect on October 1, 2020.
- From October 1, 2020, the 1st group of UDI mandated medical devices shall have unique identifiers
- Starting October 1, 2020, for initial registrations, the applicants shall submit the identifiers of the smallest sales unit to the registration management system
- Starting October 1, 2020, for renewal and modification registrations, the applicants shall submit the identifiers of smallest sales unit to the registration management system
- Starting October 1, 2020, before sales, the registrant shall upload the product identifiers and related data of the minimum sales unit and the higher-level package to the unique identification database
List of Regulations
Notices & Official Docements
- Guiding Opinions on Medical Security Standardization (June 20, 2019)
- Notice regarding the Information Mantenance for Reimbursed Drugs and Medical Consumables (June 25, 2019)
- Work Plan for the Pilot of Unique Device Identification System (July 3, 2019)
- Interpretation of Rules for Unique Device Identification System (August 3, 2019)
- First Group of Unique Device Identification Devices (Draft) (September 17, 2019)
- GB/T 33993-2017 Product QR Code (July 12, 2017)
- YY/T 1630-2018 Basic Requirements for Unique Identification of Medical Devices (November 27, 2017)
- GB/T 12905-2019 Barcode Terminology (March 25, 2019)
- YY/T 1681-2019 Basic Terminology of the Unique Identification System for Medical Devices (July 24, 2019)
- YY/T 1752-2020 Basic Data Set of Medical Device Unique Identification Database (July 9, 2020)
- YY/T 1753-2020 Guidelines for Filling in the Unique Identification Database of Medical Devices (July 9, 2020)
For an English copy of any documents above, please email us at info@ChinaMedDevice.com. We charge nominal fees for the translation.
What the UDI Plan Says
The “Unique Device Identification (UDI) System Implementation Plan” was published on July 7, 2019.
Based on the plan, the unique identifier should include the Device Identification (DI) and the Production Identification (PI). DI is the unique code identifying the license holder, the model and the packaging information of the medical device; PI is composed of codes related to the production process, the serial number, batch number, production date and expiration date. The DI and related data have to be uploaded to the Medical Device Identifier Database, within 60 days after the product is approved or renewed, and before the commercialization of the product.
Key Takeaways for Manufacturers
- The code issuing agency shall have a certified legal entity in China with a sound management system. Currently the agencies include: Zhongguancun Industry & Information Research Institute of Two-Dimensional Code Technology, Ali Health, Mashangfangxin Platform, GS1 China, etc.
- The unique identification report for the previous year shall be submitted by code issuing agencies to the NMPA before January 31 of each year.
- The identifiers of smallest sales unit shall be submitted to the registration management system.
- For devices produced since October 1, 2020, before the commercialization of the products, their identifiers shall be summited.
By October 1, 2020, the 1st group of identified device categories must be implemented with their UDI data into the China UDI data system with the qualified suppliers. As an NMPA certified legal representative, we can help you identify suppliers and make sure you comply with the UDI data requirements. info@ChinaMedDevice.com.
First Group of Devices
In early July, NMPA UDI Implementation Plan stated that “high risk implanted devices, such as cardiac implants, brain implants and prosthesis, are included in the first trial”. On September 17, 2019, NMPA issued the First Group of Unique Device Identification Devices, specifying 64 medical devices going into first group of official implementations on October 1, 2020:
- Cryoablation needle and catheter
- Absorbable suture
- Guiding catheter
- Balloon dilatation catheter
- Cutting balloon
- Thrombus aspiration catheter
- Cardiac occluder delivery cable
- Intravascular recovery device
- Capsule endoscope system
- ADSL filters
- Implantable pacemaker
- Implantable hearing device
- Knee prosthesis
- Hard brain (ridge) membrane patch
- Endovascular prosthesis
- Vascular Stent
- Plastic filling material
- Implantable access ports and accessories
- Intraocular Lens
For complete list of first group of UDI required devices, please email info@ChinaMedDevice.com.