Eighteen newly-established or revised industry standards were released by NMPA on November 24, 2023, to guide manufacturers for type testing, pre-clinical, clinical studies, and regulatory submissions.
Mandatory Standards
- YY 0315—2023 Titanium and titanium alloy dental implants
- YY 0469-2023 Medical surgical mask
- YY 0793.2—2023 Preparation and quality management of liquids for hemodialysis and related treatments Part 2: Water for hemodialysis and related treatments
- YY 1042—2023 Dentistry Polymer-based restorative materials
Recommended Standards
- YY/T 0003—2023 Manual hospital bed
- YY/T 0127.4—2023 Biological evaluation of oral medical devices Part 4: Bone implant test
- YY/T 0127.19—2023 Biological evaluation of oral medical devices Part 19: Subacute and subchronic systemic toxicity test: Implantation route
- YY/T 0489—2023 Disposable sterile drainage catheters and auxiliary devices
- YY/T 0929.3—2023 Medicinal fluid filters for infusion Part 3: Liquid bacterial retention test method for medicinal fluid filters with nominal pore size 0.22 μm
- YY/T 0969—2023 Disposable medical masks
- YY/T 1842.3—2023 Medical Devices – Connectors for Medical Liquid Storage Container Delivery Systems Part 3: Gastrointestinal Application
- YY/T 0951—2015 Interfering electrical therapy equipment
- YY/T 0919—2014 Passive surgical implants, joint replacement implants, special requirements for knee replacement implants
- YY/T 0966—2014 Surgical implants, metal materials, pure tantalum
- YY/T 1426.1—2016 Surgical implants wear of total knee prostheses Part 1: Load and displacement parameters of load-controlled wear testing machines and related test environmental conditions
- YY/T 1426.2—2016 Surgical implants Wear of total knee prostheses Part 2: Measurement methods
- YY/T 1426.3—2017 Surgical Implants Wear of total knee prostheses Part 3: Load and displacement parameters of displacement-controlled wear testing machines and related test environmental conditions
- YY/T 1447—2016 Surgical implants In vitro evaluation of apatite-forming ability of implant materials
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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