The NMPA published 20 industry standards on March 17, 2023, to guide manufacturers for local type testing, pre-clinical, clinical studies, and regulatory submissions.
NMPA Industry Standards – Mandatory
- YY 0499-2023 Anesthesia and respiratory equipment Laryngoscope for endotracheal intubation
- YY 0970-2023 Sterilization of healthcare products – Liquid chemical sterilization agents for single-use animal-derived medical devices Requirements for the characterization, development, validation and routine control of the sterilization process of medical devices
- YY 9706.231-2023 Medical electrical equipment – Part 2-31: Specific requirements for basic safety and basic performance of extracorporeal pacemakers with internal power supply
- YY 9706.256-2023 Medical electrical equipment – Part 2-56: Specific requirements for basic safety and essential performance of clinical thermometers for body temperature measurement
- YY 9706.278-2023 Medical electrical equipment – Part 2-78: Specific requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or mitigation
- YY 9706.279-2023 Medical electrical equipment – Part 2-79: Specific requirements for basic safety and essential performance of respiratory support devices for respiratory dysfunction
- YY 9706.280-2023 Medical electrical equipment – Part 2-80: Specific requirements for basic safety and essential performance of respiratory support devices for respiratory insufficiency
- YY 9706.284-2023 Medical electrical equipment – Part 2-84: Specific requirements for basic safety and essential performance of ventilators for emergency medical service environments
NMPA Industry Standards – Recommended
- YY/T 0128-2023 Medical diagnostic X-ray radiation protection devices – Devices and appliances
- YY/T 0688.1-2023 Performance evaluation of infection pathogen susceptibility test and antimicrobial susceptibility test equipment Part 1: Reference method for microdilution of broth for in vitro activity detection of fast-growing aerobic bacteria associated with infectious diseases by antimicrobials
- YY/T 0862-2023 Ophthalmic Optics Intraocular fillers
- YY/T 0893-2023 Medical gas mixer stand-alone gas mixer
- YY/T 1268-2023 Ethylene oxide sterilized product addition and process equivalence
- YY/T 1411-2023 Dentistry: Test method for waterway biofilm treatment in dental treatment machines
- YY/T 1789.5-2023 In vitro diagnostic testing system Performance evaluation methods Part 5: Analysis of specificity
- YY/T 1856-2023 General requirements for the safety of blood, intravenous drug solution and lavage fluid warmers
- YY/T 1866-2023 Disposable sterile anorectal ligator rubber ring or elastic line type
- YY/T 1874-2023 Active implantable medical devices – electromagnetic compatibility – EMC test rules for implantable pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices
- YY/T 1882-2023 Treponema pallidum antibody detection kit (luminescence immunoassay)
- YY/T 1883-2023 Rh blood group C, C, E, E antigen detection card (column agglutination method)
Industry mandatory standards are legally enforced. Decree 739 Regulation on Supervision and Management of Medical Devices, the highest law governing medical device industry in China, mandates that “medical device shall meet the national mandatory standards; if there are no national mandatory standards, they shall comply with the industry mandatory standards”.
The industry recommended standards are not legally binding but recommended by regulatory authorities.
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