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 NMPA decides that many Class II devices to subject to UDI, with the draft on November 30, 2022, and the final list on February 10, 2023.
The document “Implementation of the Third Batch of Medical Devices UDI”, askes manufacturers to prepare for UDI inclusion for the following Class II devices:
- Disposable products with large clinical demand
- varieties included in the scope of medical insurance
- 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.
For our instruction on how to comply with China’s UDI submissions requirements, please click HERE
The Third Batch Devices
For the full list of third batch of UDI devices, please email info@ChinaMedDevice.com.
- 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 (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
List of Regulations
- 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.
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- Source: https://chinameddevice.com/unique-device-identification-udi/
