Thirty-four newly established or revised industry standards were released by NMPA on October 8, 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 0271.2—2024 Dentistry – Water-based cement – Part 2: Resin-modified cement
- YY 0790—2024 Blood perfusion equipment
- YY 1105—2024 Electric gastric lavage machine
Recommended Standards
- YY/T 0107—2024 Ophthalmic A-scan ultrasonometer
- YY/T 0109—2024 Medical ultrasonic nebulizer
- YY/T 0294.1—2024 Surgical instruments – Materials – Part 1: Metal materials
- YY/T 0339—2024 Suction catheters for respiratory tract use
- YY/T 0576—2024 Columbia blood agar medium
- YY/T 0581.2—2024 Infusion connectors – Part 2: Needle-free connectors
- YY/T 0688.2—2024 Clinical laboratory testing and in vitro diagnostic systems – Performance evaluation of susceptibility test devices for infectious pathogens and antimicrobial susceptibility – Part 2: Evaluation of antimicrobial susceptibility test devices compared to broth microdilution reference method
- YY/T 0787—2024 Ophthalmic instruments – Corneal topography devices
- YY/T 0802.1—2024 Processing of medical devices – Information provided by the manufacturer – Part 1: Medium to high-risk medical devices
- YY/T 0802.2—2024 Processing of medical devices – Information provided by the manufacturer – Part 2: Low-risk medical devices
- YY/T 0860—2024 Cardiac radiofrequency ablation treatment equipment
- YY/T 0866—2024 Medical protective masks total leakage rate testing method
- YY/T 1183—2024 Enzyme-linked immunosorbent assay (ELISA) test kits
- YY/T 1233—2024 Cardiac troponin test kits (labeled immunoassay)
- YY/T 1284—2024 Dentistry – Dental forceps
- YY/T 1529—2024 Enzyme-linked immunosorbent assay (ELISA) analyzer
- YY/T 1585—2024 25-Hydroxyvitamin D test kits
- YY/T 1686—2024 Medical electrical equipment using robotic technology – Terminology, definitions, classification
- YY/T 1833.5—2024 Artificial intelligence medical devices – Quality requirements and evaluation – Part 5: Pre-trained models
- YY/T 1860.1—2024 Passive surgical implants – Implant coatings – Part 1: General requirements
- YY/T 1926.2—2024 Spinal implant devices – Preclinical mechanical performance evaluation and special requirements – Part 2: Intervertebral fusion devices
- YY/T 1930—2024 Medical device clinical evaluation – Terminology and definitions
- YY/T 1938—2024 Medical-grade sodium hyaluronate dressing
- YY/T 1940—2024 Medical nickel-titanium alloy powder for additive manufacturing
- YY/T 1941—2024 Robotic-assisted laparoscopic surgical systems
- YY/T 1944—2024 Technical requirements for medical X-ray high voltage generators
- YY/T 1946—2024 Tumor tissue gene mutation test kits (high-throughput sequencing method)
- YY/T 1949—2024 Artificial intelligence medical devices – Dataset-specific requirements: Fundus color images for diabetic retinopathy
- YY/T 1950—2024 Tissue-engineered medical devices – Silk fibroin
- YY/T 1951—2024 General requirements for tissue-engineered medical devices – Bio-originated peripheral nerve repair implants
- YY/T 1952.1—2024 Dentistry – Materials for dental instruments – Part 1: Stainless steel
For English version of any standards above, please email info@ChinaMedDevice.com. We charge nominal fees for the translation.
