China UDI medical device third batch implementation date has been officially released by the National Medical Products Administration (NMPA). The third batch of China UDI for medical devices comes into effect on June 1, 2024.
This third batch follows the implementation of 69 types of Class III medical devices on January 1, 2021. As well as the second batch of remaining Class III on June 1, 2022.
As part of the continuing drive to improve supervision and management of medical devices & IVDS in China, the UDI implementation program is now being rolled out to certain Class II medical devices.
Which medical devices are affected?
Certain Class II medical devices have been selected for this third batch of China UDI implementation. They include:
- some single-use products with large clinical demand
- products in the scope of medical insurance centralized procurement
- medical cosmetology-related products
- other Class II medical devices
Overriding medical device categories that are affected:
- Active surgical instruments e.g. ultrasound
- Passive surgical instruments e.g. staplers
- Instruments for neurological and cardiovascular surgery e.g. catheter sterilization connector
- Orthopedic surgical instruments e.g. bone grafting instruments
- Medical imaging equipment e.g. oral x-ray machine
- Medical examination and monitoring equipment e.g. pulse oximeter
- Respiration, anesthesia and first aid equipment e.g. intubation
- Physical therapy equipment e.g. red light therapy equipment
- Blood transfusion, dialysis and cardiopulmonary bypass instruments e.g. peritoneal dialysis equipment
- Active implantation devices e.g. neuro test stimulator
- Infusion, nursing and protective equipment eg urinary catheter
- Ophthalmic instruments e.g. laser diagnostic equipment
- Obstetrics and gynecology, assisted reproduction and contraceptives, e.g. egg retrieval needle
- Medical rehabilitation equipment e.g. hearing aids
- Clinical testing instruments e.g. blood sample collection devices
Actions to be taken
- UDI labelling requirements
- If your product is manufactured on or after the June 1, 2024, then before placing it on the market, you must have approval from the NMPA for the UDI itself. The process to obtain approval of a UDI Code by the NMPA is different to that of submitting your UDI as part of the medical device registration application (see below).
- UDI Database requirements
- Once the UDI Code is approved you will need to upload the UDI Code to the NMPA’s UDI database.
- For medical devices that have records in the NMPA’s Medical Insurance Medical Consumables Database, you must supplement your records with the UDI Code as well as update relevant medical insurance medical consumables classification and code fields in the UDI Database at the same time.
- Requirements when registering, changing or renewing medical device certificates
- For Class II medical devices registered before June 1, 2024:
- If the date on your registration certificate is before June, 1, 2024, then you only need to submit the UDI to the NMPA when you renew or make changes to your registration, however labelling requirements still apply (see above).
- For example: standards that apply to your medical device have changed and require the product to undergo new type testing and a change modification to your registration to be submitted. In such cases you must submit the UDI code when the change modification or certificate is being renewed.
- For new registrations from June 1, 2024, onwards:
- If the date on your registration certificate is expected to be June 1, 2024, onwards, then the UDI of the smallest unit of your product must be submitted as part of the medical device registration application, and labelling requirements also apply (see above).
- Please note that it takes 18 months at least to register a class II medical device that’s if type testing goes to plan and a clinical trial is not required.
- For Class II medical devices registered before June 1, 2024:
Further information
Refer to the draft for comments on the China UDI medical device third batch issued in December 2022.
Get in touch with your NMPA Legal Agent or Cisema to see how this legislation affects your Class II medical device to ensure you are fully compliant by the implementation date.
