Q&A – China UDI

What is China UDI?

The Unique Device Identification (UDI) 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.

What are key NMPA regulation for UDI?

Policy
• State Council: Opinions on Accelerating the Construction of Traceability System for Important Products (January 2016)
• State Council:The 13th Five-Year National Drug Safety Plan (February 2017)
• State Council:Deepening Regulatory Reform (April 2017)
• State Council: Notice on Reform Plan of Managing High-value Medical Consumables (July 2019)
• State Council: Guiding Opinion of Strengthening and Standardizing Supervision During and After the Event (September 2019)
• State Council:Deepening Regulatory Reform (July 2020)

Regulation:
• Opinions on Promoting the Food and Drug Manufacturers to Improve Traceability System (No. 122, 2016)
• Ministry of Justice Draft Amendment to Regulation of Medical Device Supervision and Management (Draft) #680
• Rules for Unique Device Identification System (No. 66, 2019)
• Pilot Project Plan for UDI System for Medical Devices (No.56, 2019)

Standards:
• GB/T 33993-2017 Product QR Code (July 2017)
• YY/T 1630-2018 Fundamental Requirements of UDI (December 2018)
• YY/T 1681-2019 Basic Terms of UDI System (July 2019)
• GB/T 12905-2019 Barcode Terminology (March 2019)
• YY/T 1752-2020 Basic Dataset of UDID (July 2020)
• YY/T 1753-2020 Reporting Guide of UDID (July 2020)

What are the first batch of UDI devices in China

In early July 2019, 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 based on NMPA classification catalog, including 9 categories: surgical instruments (active/passive/nerve and cardiovascular); imaging equipment; implants (active/passive); blood transfusion; dialysis and extracorporeal circulation equipment; infusion, care and protective equipment; ophthalmic equipment.

What is the date of UDI implementation in China?

On September 30, 2020, NMPA issued a notice that postponed the UDI implementation date. The first batch of medical devices has changed from October 1st, 2020 to January 1st, 2021.

Five more types of high-risk class III implantable devices have been added to the first batch of devices for UDI implementation. Additionally, NMPA encourages more companies to voluntarily participate in Phase 1 of the UDI implementation. This will especially focus on products from ‘the first batch of national high-value medical consumables list.’