NMPA Announces 10 New Medical Device Industry Standards
February 28, 2025 - The National Medical Products Administration (NMPA) of China has announced the publication of 10 new medical device industry standards, which will come into effect between March 2026 and March 2028.
Among the key standards is YY 0267-2025, which updates the requirements for extracorporeal circulation blood/fluid pathways used in blood purification systems, including hemodialyzers, hemodiafiltration filters, hemofiltration devices, and hemoconcentrators. This revised standard will replace the 2016 version and takes effect on March 1, 2028.
Other significant standards include:
- YY 0459-2025: A revised standard for surgical implants and acrylic bone cement
- YY 9706.287-2025: New requirements for high-frequency ventilators' basic safety and performance
- Several new standards (YY/T series) covering various medical devices such as:
- Nickel-titanium shape memory alloy cables for surgical implants
- Human factors design requirements for orthopedic implants
- Recombinant collagen dressings
- Clinical trial terminology for in vitro diagnostic reagents
These standards aim to enhance the quality and safety of medical devices in China's healthcare system. Most of the newly established standards (YY/T series) will be implemented starting March 1, 2026, while the revised standards will take effect on March 1, 2028.
The announcement demonstrates China's ongoing commitment to updating and improving its medical device regulations to meet evolving healthcare needs and technological advances in the industry.