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NMPA Guideline Proposes All Class III Devices Subject to UDI

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Unique Device Identification (UDI) will be implemented with all Class III devices, announced by NMPA at the “Notice on Applying Unique Device Identification System for the Second Group of Devices (draft for feedback)” on May 31, 2021. The proposed effective date of January 1, 2022. Feedbacks need to be submitted by June 15, 2021.

69 high-risk class III device were included in the UDI application of First Group of Devices, which started from January 1, 2021 (For the official updated list of First Group of Unique Device Identification Devices, please email info@ChinaMedDevice.com). Now all the rest of Class III devices will follow suit. The draft guideline proposes that:

  • Devices manufactured after January 1, 2021, shall have unique identifiers.
  • Devices manufactured before January 1, 2021, are not required to have unique identifiers.
  • Starting January 1, 2021, for initial registrations, renewal and modification registrations, the applicants shall submit the identifiers of the smallest sales unit to the registration management system.

The document also gives instructions for manufacturers, suppliers and provincial NMPA offices and health departments with regarding to recall, traceability, data uploading and public tendering and reimbursement.

What the UDI Database Looks Like

The UDI Database page (https://udi.nmpa.gov.cn) includes the following sections:

  • Filing entrance
  • UDI Regulations
  • UDI news
  • Database operations manual
  • Data declaration manual
  • Data docking manual
  • Q&A
  • Issuing agents & rules

The NMPA statistics show that, as of November 8, there were 542,582 identifiers uploaded, 1,834 to be uploaded and 22,876 drafted.

Among the total of 567,077 identifiers, 96.81% are devices and 3.11% are IVDs.

List of Regulations

Notices & Official Documents

  • Guiding Opinions on Medical Security Standardization (June 20, 2019)
  • Notice regarding the Information Maintenance 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)

Standards

  • 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.

Services We Offer

As an NMPA certified legal representative, we help you complete UDI China implementation process from defining UDI form to uploading DI (device identifier) to database:

Define UDI form

  • Figure out the differences of classification code between old and new Medical Device Classification Catalogs

Identify issuing agency

  • Choose from GS1 China, Zhongguancun Industry & Information Research Institute of Two-Dimensional Code Technology, Ali Health, Mashangfangxin Platform, 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.

Report DI data

  • During registration/filing/change and before the product is put on the market for sale
  • Choose one way of reporting: interface exchange, online reporting, or data template exchange

Upload DI to database

  • A total of 50 data attributes (25 mandatory, 10 conditional mandatory and 15 optional)
  • For devices produced since January 1, 2021, before the commercialization of the products, their identifiers shall be submitted

Communication

  • Advocate with the NMPA during the pilot and regulation/standards development.

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