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2023 China NMPA Bluebook is here:

141 Class II Devices Proposed to UDI Starting June 1, 2024


69 high-risk class III devices were included in the Unique Device Identification (UDI) application of First Group of Devices, which started from January 1, 2021. After that, UDI has been implemented with all Class III devices and IVDs, effective from June 1, 2022. Now the NMPA proposes many Class II devices to subject to UDI, with an announcement on November 30, 2022.

The draft document “Implementation of the Third Batch of Medical Devices UDI”, asked manufacturers to prepare for UDI inclusion for the following Class II devices:

  1. Disposable products with large clinical demand
  2. varieties included in the scope of medical insurance
  3. medical cosmetic products

The notice says that:

  • Above Class II devices manufactured after June 1, 2024, shall have unique identifiers.
  • Devices manufactured before June 1, 2024, are not required to have unique identifiers.
  • Starting June 1, 2024, for initial registrations, renewal and modification registrations, the applicants shall submit the identifiers of the smallest sales unit to the registration management system.

View our instruction on how to comply with China’s UDI submissions requirements

The Third Batch Devices

For the full list of third batch of UDI devices, please email

  • Ultrasound Surgery Equipment Accessories
  • Medical laser fiber
  • High-frequency surgical equipment
  • Argon protects aerocoagulation equipment
  • Electrodes and catheters for high frequency/radio frequency
  • Perfusion pumps for RF ablation equipment
  • Active devices for endoscopic surgery
  • Electric stapler
  • Surgical power system
  • Endoscopic knife
  • Endoscopic sampling forceps
  • Airbag dilator for endoscope
  • Endoscope guides
  • Stapler (with nails)
  • Stapler (without spikes)
  • Vascular suture device
  • Non-absorbable sutures
  • Lithotomy instruments for endoscopy
  • Bladder catheters for endoscopes
  • Dilator
  • Balloon compression device for balloon dilation catheters
  • Orthopedic endoscope with a knife
  • Orthopedic power surgery equipment
  • Urinary X-ray machine
  • Laser treatment equipment
  • Cardiac rhythm management program-controlled devices
  • Neuromodulation program-controlled devices
  • Syringe pump
  • Pen injectors
  • Transnasoenteral nutrition catheter
  • Pocket tension ring implantation device
  • Hysterosalpingography, fallopian tubes
  • Gynecological prosthetic devices
  • Assisted reproductive catheters
  • Blood cell analysis instruments

What the UDI Database Looks Like

The UDI Database page ( includes the following sections:

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

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)


  • 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 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


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

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