China's NMPA Announces 34 New Medical Device Industry Standards
On October 8, 2024, the National Medical Products Administration (NMPA) of China announced the publication of 34 new medical device industry standards. These standards, which cover a wide range of medical devices and technologies, were approved on September 29, 2024, and will come into effect on various dates between 2025 and 2027.
Key highlights of the new standards include:
1. Dental Science: The YY 0271.2-2024 standard for resin-modified water-based cements in dentistry will be implemented on October 15, 2027. This standard specifies requirements for resin-modified cements used in dental procedures.
2. Artificial Intelligence in Medical Devices: Several standards address the growing field of AI in healthcare, including YY/T 1833.5-2024 for pre-trained models in AI medical devices, and YY/T 1949-2024 for dataset requirements for AI devices used in diabetic retinopathy detection.
3. Surgical Implants: New standards have been introduced for implant coatings (YY/T 1860.1-2024) and spinal implants (YY/T 1926.2-2024), focusing on mechanical performance evaluation and special requirements.
4. Robotic Surgery: The standard YY/T 1941-2024 sets requirements for robotic laparoscopic surgery systems, reflecting the increasing use of robotics in medical procedures.
5. Genetic Testing: YY/T 1946-2024 establishes standards for tumor tissue gene mutation detection kits using high-throughput sequencing methods.
6. Tissue Engineering: Standards for silk fibroin protein (YY/T 1950-2024) and biological peripheral nerve repair implants (YY/T 1951-2024) have been introduced, addressing the growing field of tissue engineering in medical devices.
These new standards demonstrate China's commitment to advancing its medical device industry and ensuring the safety and efficacy of a wide range of healthcare technologies. The standards cover traditional medical devices as well as cutting-edge technologies like AI and robotics, indicating the country's focus on innovation in the healthcare sector.
Medical device manufacturers and healthcare providers operating in China will need to familiarize themselves with these new standards and ensure compliance by their respective implementation dates. The NMPA's announcement marks an important step in the ongoing development and regulation of China's medical device industry.