China UDI Takes Effect Jan 1, 2021; UDI Database Launched

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NMPA launched Unique Device Identification (UDI) Database on its website on August 10, 2020, facilitating the implementation of China UDI system for the first group of devices which will take effect on January 1, 2021.

What the UDI Database Looks Like

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

  1. Filing entrance
  2. UDI Regulations
  3. UDI news
  4. Database operations manual
  5. Data declaration manual
  6. Data docking manual
  7. Q&A
  8. Issuing agents & rules

The NMPA statistics show that, as of November 8, there were 137,138 identifiers uploaded, 20,971 to be uploaded and 34,447 drafted.

Among the total of 163,021 identifiers, 96.42% are devices’ and 3.58% are IVDs’.

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

  • total 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 summited

Communication

  • advocate with NMPA during the pilot  and regulation/standards development

Timeline

NMPA “Pilot Program on Implementation of the First Batch of Unique Device Identification” delayed the China UDI system implementation date from October 1, 2020 to January 1, 2021.

  • From January 1, 2021, the 1st group of UDI medical devices shall have unique identifiers
  • Starting January 1, 2021, for initial registrations, the applicants shall submit the identifiers of the smallest sales unit to the registration management system
  • Starting January 1, 2021, for renewal and modification registrations, the applicants shall submit the identifiers of smallest sales unit to the registration management system
  • Starting January 1, 2021, 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)

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.

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 Identifier (DI) and the Production Identifier (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.

By January 1, 2021, 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 issuing agencies and make sure you comply with the UDI data requirements. info@ChinaMedDevice.com.

First Group of Devices

In July 2019, the NMPA UDI Implementation Plan stated that “high risk implanted devices, such as cardiac implants, brain implants and prosthesis, are included in the firstbatch of devices to be compliant with UDI”. On September 17, 2019, NMPA issued the First Group of Devices requiring UDI,  in which 64 medical devices are required to have UDI label implemented on them  by January 1, 2021:

  1. Cryoablation needle and catheter
  2. Absorbable suture
  3. Guiding catheter
  4. Balloon dilatation catheter
  5. Cutting balloon
  6. Thrombus aspiration catheter
  7. Cardiac occluder delivery cable
  8. Intravascular recovery device
  9. Capsule endoscope system
  10. ADSL filters
  11. Implantable pacemaker
  12. Implantable hearing device
  13. Knee prosthesis
  14. Hard brain (ridge) membrane patch
  15. Endovascular prosthesis
  16. Vascular Stent
  17. Plastic filling material
  18. Implantable access ports and accessories
  19. Intraocular Lens

……

For the complete list of first group of UDI required devices, please email info@ChinaMedDevice.com.

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