The NMPA published twenty industry standards on October 17, 2022, to guide manufacturers for local type testing and regulatory approval.

Mandatory NMPA Standards October 2022

• YY 0719.2-2022 Ophthalmic optics – Contact lens care products – Part 2: Basic requirements
• YY 0290.8-2022 Ophthalmic optics – Intraocular lenses – Part 8: Basic requirements
• YY 0650-2022 General technical requirements for radiofrequency ablation equipment
• YY 1289-2022 Laser Therapy Equipment Ophthalmic Laser Photocoagulation Apparatus

Recommended Standards

• YY/T 0633-2022 Ophthalmic instruments Indirect ophthalmoscope
• YY/T 0698.2-2022 Packaging materials for terminally sterilized medical devices – Part 2: Sterilization packaging materials – Requirements and test methods
• YY/T 0719.10-2022 Ophthalmic optics-Contact lens care products-Part 10: Determination of moisturizing lubricants
• YY/T 0952-2022 Medical temperature controller
• YY/T 0989.5-2022 Surgical Implants Active Implantable Medical Devices Part 5: Circulatory Support Devices
• YY/T 1043.1-2022 Dentistry-Non-mobile dental treatment machines and dental patient chairs-Part 1: General requirements
• YY/T 1293.2-2022 Contact wound dressings-Part 2: Polyurethane foam dressings
• YY/T 1464-2022 Sterilization of health care products – Low temperature steam formaldehyde – Requirements for the development, validation, and routine control of medical device sterilization processes
• YY/T 1844-2022 Anesthesia and respiratory equipment – General requirements for airway and related equipment
• YY/T 1855-2022 Test method for fatigue performance of combined ceramic femoral head
• YY/T 1857-2022 Dentistry Digging spoons and bone curettes
• YY/T 1859-2022 Anti-calcification evaluation of animal-derived cardiovascular implants Subcutaneous implantation test in rats
• YY/T 1865-2022 General technical requirements for BRCA gene mutation detection kits and databases (high-throughput sequencing method)
• YY/T 1877-2022 Method for the determination of bisphenol-based propane (BPA) residues in extracorporeal circulation devices
• YY/T 1880-2022 Serum Amyloid A Assay Kit
• YY/T 1064-2022 Dentistry – General requirements for drills for dental implant surgery

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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