China medical device standards management 2022 annual report issued

China medical device standards management 2022 annual report was issued by the NMPA (National Medical Products Administration) on February 8, 2023, to provide a comprehensive overview of the standards development in 2022.

Highlights

• A total of 1,919 medical device standards have been recorded in China in 2022:
  • 260 National Standards:
    • 96 GB Standards
    • 164 GB/T Standards
  • 1,659 Industry Standards
    • 188 YY Standards
    • 1,471 YY/T Standards
• 154 new medical device standards were officially released in 2022, consisting of 40 new national standards and 114 new industrial standards.
• Among all medical device standards, the top 5 fields with the most standards distributed are:
  1. C44 medical laboratory equipment (14%)
  2. C35 orthopedic instruments (11%)
  3. C31 general and microsurgical instruments (11%)
  4. C30 comprehensive medical device (10%)
  5. C33 dental devices, equipment and materials (9%)
• Among the 154 new medical standards issued in 2022, the top 3 fields with the most standards distributed are:
  • C30 comprehensive medical device
  • C33 dental devices, equipment and materials
  • C35 orthopedic instruments
• According to the report, China focused on the development of 64 industry standards covering high-end innovative products such as artificial intelligence (AI) medical devices, new biomedical materials, products utilizing new diagnostic technologies, etc.
• Led by China, three international standards were official released in 2022:
  • Part 15: Single-use light-proof infusion set of the ISO 8536-15 standard was officially released on March 8, 2022. Working together with Germany, the United States and many other countries, the China Standard Administration of China (SAC) TC106 committee took four years to finalize the international standard and the testing methods for light-proof infusion sets.
  • China took the initiative to develop the ISO/TS 5798:2022 to sets out the requirements and recommendations for in vitro diagnostic test systems for the detection of novel coronavirus (SARS-CoV-2) with nucleic acid amplification. The standard was officially released on April 19, 2022.
  • The China SAC TC110/SC3 committee led the implementation of ISO/TS 24560-1:2022 to standardize the magnetic resonance imaging assessment of regenerated articular cartilage tissue-engineered medical products clinical with the clinical application of dGEMRIC and T2-mapping. The standard was officially released in July 2022.

Further information

Refer to NMPA’s original China medical device standards management 2022 annual report.

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