MEDTECH NEWS
China's NMPA Announces 34 New Medical Device Industry Standards
11 10 2024China's National Medical Products Administration announced 34 new medical device industry standards on October 8, 2024. These standards cover various areas including dental materials, blood purification equipment, ophthalmology instruments, surgical implants, AI in medical devices, robotic surgical systems, genetic testing kits, and tissue engineering materials. The standards aim to regulate performance, safety, and quality requirements, reflecting technological advancements in China's medical device industry. Implementation dates range from 2025 to 2027.
NMPA Releases 48 New Guidelines for Medical Device Registration Review
28 05 2024On May 27, 2024, the Center for Medical Device Evaluation (CMDE) of the National Medical Products Administration (NMPA) released 48 new guidelines for the registration review of various medical devices, including electric photography beds. The guidelines cover a wide range of medical device categories, such as diagnostic equipment, therapeutic devices, auxiliary equipment, rehabilitation tools, and in vitro diagnostic reagents. These guidelines aim to standardize the registration process, enhance industry standards, and ensure the safety and effectiveness of medical devices. Detailed guidelines for specific devices, including medical gas alarm systems, air-oxygen blenders, radiotherapy laser positioning devices, and various testing reagents, are provided to support manufacturers in meeting regulatory standards. The full texts of these guidelines are available on the NMPA's official CMDE website.