TX Medical - China Sets New Benchmarks in Medical Device Industry with Ambitious 2023 Standardization Initiatives

China Sets New Benchmarks in Medical Device Industry with Ambitious 2023 Standardization Initiatives

23 02 2024

In 2023, China significantly advanced its medical device industry by approving and publishing a wide range of national and industry standards, establishing key standardization technical organizations, and reinforcing its commitment to safety, innovation, and global competitiveness.

In 2023, China has made significant strides in the standardization of medical devices, with the approval and issuance of new standards aimed at enhancing the industry's regulatory framework and promoting innovation. The National Standardization Committee approved 52 new national standard projects for medical devices, focusing on both the creation of new standards (34 items, 65.4%) and the revision of existing ones (18 items, 34.6%). Of these, four are mandatory standards (7.7%), while the majority are recommended (46 items, 88.5%) and two are guidance technical documents (3.8%). Additionally, the National Medical Products Administration approved 117 industry standard projects, with a balance between new standards (57 items, 48.7%) and revisions (60 items, 51.3%), including 15 mandatory standards (12.8%) and 102 recommended standards (87.2%).

The year also saw the approval and publication of 28 national standards and 131 industry standards for medical devices, with a notable distribution between new standards and revisions, highlighting the commitment to both innovation and updating existing regulations. As of December 31, 2023, there are 1,974 effective medical device standards in China, encompassing national standards (271 items) and industry standards (1,703 items), covering various technical fields within the medical device sector.

Significantly, 2023 marked the establishment of specialized standardization technical organizations, including the National Medical Protective Devices Standardization Working Group (SAC/SWG30), and the approval for the establishment of standardization technical committees focused on medical device reliability, maintenance, and digital dental devices. By the end of the year, there were 38 standardization technical organizations dedicated to medical devices, indicating a robust framework for the development and oversight of medical device standards in China. This progress underscores China's efforts to align with global standards, ensuring the safety, efficacy, and quality of medical devices in the market.

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China Sets New Benchmarks in Medical Device Industry with Ambitious 2023 Standardization Initiatives

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