The National Medical Products Administration (NMPA) has unveiled the “2024 Medical Device Industry Standard Revision Plan Project,” calling for the participation of medical products administration bureaus from key provinces and cities, including Beijing, Tianjin, Liaoning, Shanghai, Jiangsu, Zhejiang, Shandong, Hubei, and Guangdong, as well as Guangzhou city. The National Institutes for Food and Drug Control, the Center for Medical Device Standardization Administration NMPA, the Center for Medical Device Evaluation, NMPA, Dental Medical Devices Testing Center of Peking University School of Stomatology, and Instrumentation Technology And Economy Institute are also set to take part in this initiative.
The project encompasses eight mandatory revisions, with a particular focus on the development of the “Special Requirements for Basic Safety and Basic Performance of Respiratory Equipment Infant Cardiopulmonary Monitor.” The other seven items involve mandatory revisions primarily for equipment related to joint replacement, dentistry, and extracorporeal cardiopulmonary support. Additionally, there are 90 recommended revisions, comprising 53 recommended development revisions and 37 recommended updates. – Flcube.com
