Thirty-Two Industry Standards Issued in One Day (2024)

The NMPA published thirty-two industry standards on January 16, 2023, to guide manufacturers for local type testing, pre-clinical, clinical studies, and regulatory submissions.

NMPA Industry Standards January 2023

Mandatory Standards

• YY 0054-2023 Hemodialysis equipment
• YY 0777-2023 Radiofrequency hyperthermia equipment
• YY 9706.230-2023 Medical electrical equipment – Part 2-30: Specific requirements for basic safety and basic performance of automatic non-invasive blood pressure monitors
• YY 9706.246-2023 Medical electrical equipment – Part 2-46: Specific requirements for basic safety and basic performance of operating tables
• YY 9706.249-2023 Medical electrical equipment – Part 2-49: Specific requirements for basic safety and basic performance of multi-parameter patient monitors
• YY 9706.261-2023 Medical electrical equipment – Part 2-61: Specific requirements for basic safety and basic performance of pulse oximetry equipment
• YY 9706.277-2023 Medical electrical equipment – Part 2-77: Specific requirements for basic safety and essential performance of assisted surgical equipment using robotic technology

Recommended Standards

• YY/T 0606.15-2023 Medical products for tissue engineering – Test method for evaluating the immune response of matrix and scaffold: lymphocyte proliferation test
• YY/T 0720-2023 Single-use production kits General requirements
• YY/T 0730-2023 Cardiovascular surgical implants and artificial organs – Requirements for single-use tubing kits for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO) use
• YY/T 0870.7-2023 Genotoxicity test for medical devices – Part 7: Alkaline comet test in mammals
• YY/T 1199-2023 Triglyceride determination kit (enzymatic method)
• YY/T 1240-2023 D-dimer assay kit (immunoturbidimetric method)
• YY/T 1473-2023 Medical Device Standardization Work Guide Standard development involving safety content
• YY/T 1789.6-2023 In vitro diagnostic testing system Performance evaluation methods Part 6: Precision, diagnostic sensitivity and specificity of qualitative reagents
• YY/T 1842.7-2023 Medical devices: Connectors for medical storage container transport systems – Part 7: Connectors for intravascular infusion
• YY/T 1850-2023 Male condoms – Technical requirements and test methods for polyurethane condoms
• YY/T 1861-2023 Special technical conditions for medical image storage and transmission system software
• YY/T 1862-2023 Special technical conditions for coronary CT image processing software
• … …

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.

For English version of any standards above, please email info@ChinaMedDevice.com. We charge nominal fees for the translation.