Thirty-six newly established or revised industry standards were released by NMPA on July 10, 2024, to guide manufacturers for type testing, pre-clinical, clinical studies, and regulatory submissions.
Significance of Compliance
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.
Mandatory Standards
- YY 0117.1—2024 Surgical implants – Forgings and castings for bone and joint prostheses – Part 1: Ti6Al4V titanium alloy forgings
- YY 0117.2—2024 Surgical implants – Forgings and castings for bone and joint prostheses – Part 2: ZTi6Al4V titanium alloy castings
- YY 0117.3—2024 Surgical implants – Forgings and castings for bone and joint prostheses – Part 3: Cobalt-chromium-molybdenum alloy castings
- YY 0329—2024 Disposable leukocyte reduction filters
- YY 0580—2024 Cardiovascular implants and artificial organs – Cardiopulmonary bypass systems – Arterial blood filters
- YY 0585.4—2024 Disposable liquid paths and accessories for pressure infusion devices – Part 4: Anti-reflux valves
- YY 0599—2024 Laser treatment equipment – Excimer laser refractive surgery system
- YY 0603—2024 Cardiopulmonary bypass systems – Hard shell reservoirs, venous reservoirs (with or without filters), and venous blood bags for cardiac surgery
- YY 0789—2024 Laser treatment equipment – Q-switched ophthalmic laser treatment system
- YY 0792—2024 Ophthalmic instruments – Intraocular illuminators
- YY 0861—2024 Ophthalmic optics – Ophthalmic viscoelastic devices
Recommended Standards
- YY/T 0063—2024 Medical electrical equipment – Medical diagnostic X-ray tube assemblies – Focal spot dimensions and related characteristics
- YY/T 0282—2024 Hypodermic needles
- YY/T 0810.1—2024 Joint replacement implants – Total knee joint prostheses – Part 1: Determination of tibial tray fatigue performance
- YY/T 0865.1—2024 Ultrasound – Hydrophones – Part 1: Measurement and characterization of medical ultrasonic fields
- YY/T 0870.8—2024 Genetic toxicity tests for medical devices – Part 8: In vivo mammalian hepatocyte unscheduled DNA synthesis test
- YY/T 0916.7—2024 Small-bore connectors for liquids and gases in healthcare applications – Part 7: Connectors for intravascular or hypodermic applications
- YY/T 0923—2024 Test methods for microbial ingress into liquid and blood pathways
- YY/T 0924.2—2024 Joint replacement implants – Partial and total knee joint prosthesis components – Part 2: Metal, ceramic, and plastic bearing surfaces
- YY/T 1117—2024 Plaster bandages
- YY/T 1148—2024 Lumbar puncture needles
- YY/T 1306—2024 Fumigation therapy equipment
- YY/T 1307—2024 Detectors for digital mammography
- YY/T 1535—2024 Medical devices for assisted reproductive technology – Human sperm survival assay
- YY/T 1550.3—2024 Guidelines for compatibility testing of disposable infusion devices with pharmaceuticals – Part 3: Leachables study – Unknown substances
- YY/T 1754.4—2024 Preclinical animal research for medical devices – Part 4: Acute wound models for evaluating wound dressing promotion
- YY/T 1786—2024 Hepatitis B virus e antigen test kits (chemiluminescent immunoassay)
- YY/T 1922—2024 Sports medicine implants – Tendon and ligament fixation screws
- YY/T 1932—2024 Dentistry – Clear aligners
- YY/T 1933—2024 Technical specifications for magnetic resonance imaging injection devices
- YY/T 1935—2024 Safety requirements and test methods for implantable cardiac pacemakers and cardioverter defibrillators in the MRI environment
- YY/T 1936—2024 Custom-made fixed dental prostheses
- YY/T 1937—2024 Custom-made removable dental prostheses
- YY/T 1939—2024 Test methods for bacterial endotoxins in medical devices – Recombinant Factor C assay
- YY/T 1942—2024 Form and content of unique device identification for medical devices
- YY/T 1943—2024 Packaging implementation and application of unique device identification for medical devices
For English version of any standards above, please email info@ChinaMedDevice.com. We charge nominal fees for the translation.
