China medical device industry standards March 2023 update covers 20 mandatory and recommended standards for specific medical electrical equipment. These new standards were announced (No. 29 of 2023) by the National Medical Products Administration (NMPA) on March 17, 2023. There are various implementation dates between November 1, 2023, and May 1, 2026.
The standards include sub-parts of the recently revised GB9706-2020 standard affecting medical electrical equipment. This series of standard updates covers products from pacemakers to medical robots.
The standards cover various aspects and may include any of the following:
- product characteristics
- safety and performance requirements
- explain which products they do not apply to
- terms, definitions test methods
- labelling and instruction manuals
- packaging, transportation and storage requirements.
Implications for medical device manufacturers
If your product is subject to any of the 8 mandatory standards, then the product must undergo a change of registration or filing as the Product Technical Requirement (PTR) has to specify the new standards which are applicable to the product. Type testing must be carried out again to demonstrate compliance with the new mandatory standard.
If your product is subject to any of the 12 recommended standards, then it is highly advisable to undertake the same actions as for mandatory standards to ensure best practice for the Chinese market.
Here below is a breakdown of the newly released standards for reference.
Mandatory industry standards for medical devices
- YY0499-2023 – Laryngoscope for Tracheal Intubation in Anesthesia and Respiratory Equipment
- YY 0970-2023 – Healthcare Products Sterilization Liquid Chemical Sterilizers for Disposable Use of Animal-Originated Medical Devices Characteristics, Development, Identification and Conventional Control Requirements for the Sterilization Process of Medical Devices
- YY9706.231-2023 – Medical electrical equipment Part 2-31：the basic safety and basic performance of external pacemakers with internal power supply special requirements
- YY9706.256-2023 – Medical Electrical Equipment Part 2-56: Basic Safety and Basic Performance Special Requirements for Clinical Thermometers for Temperature Measurement
- YY9706.278-2023 – Medical electrical equipment—Part 2-78: Particular requirements for basic safety and basic performance of medical robots for rehabilitation, assessment, compensation or mitigation
- YY9706.279-2023 – Medical electrical equipment—Part 2-79: Particular requirements for basic safety and basic performance of respiratory support equipment for respiratory dysfunction
- YY9706.280-2023 – Medical electrical equipment—Part 2-80: Particular requirements for basic safety and basic performance of respiratory support equipment for respiratory insufficiency
- YY9706.284-2023 – Medical electrical equipment—Part 2-84: Particular requirements for basic safety and basic performance of ventilators for emergency medical service environments.
Recommended industry standards for medical devices
- YY/T0128-2023 – Medical diagnostic X-ray radiation protection devices and appliances
- YY/T0688.1-2023 – Performance evaluation of equipment for susceptibility testing of infectious agents and antimicrobial drug susceptibility testing Part 1: Broth microdilution reference method for the in vitro activity testing of antimicrobials against fast-growing aerobic bacteria associated with infectious diseases
- YY/T0862-2023 – Ophthalmic optical intraocular filler
- YY/T0893-2023 – Medical gas mixer independent gas mixer
- YY/T1268-2023 – Product addition and process equivalence of ethylene oxide sterilization
- YY/T1411-2023 – Test method of aqueous biofilm treatment for dental treatment machines in dentistry
- YY/T1789.5-2023 – Performance evaluation method for in vitro diagnostic test system Part 5: Analytical Specificity
- YY/T1856-2023 – General requirements for safety of blood, intravenous fluids and irrigation fluid warmers
- YY/T1866-2023 – Disposable sterile anorectal ligation device rubber ring or elastic thread type
- YY/T1874-2023 – Electromagnetic compatibility test rules for active implantable medical devices implantable cardiac pacemakers, implantable cardioverter-defibrillators and cardiac resynchronization devices.
Industry standards for in vitro diagnostics (IVD)
- YY/T1882-2023 – Syphilis spirochete antibody test kit (luminescent immunoassay)
- YY/T1883-2023 – Rh blood group C, c, E, e antigen test card (column agglutination method)
Read our article on the upcoming China medical electrical equipment GB9706 standard which comes into effect on May 1, 2023.
Read the full announcement on the recent China medical device standards released in March 2023: