China Medical Device Standardization 2019

By October 2019, China has established 549 technical committees SAC / TC, 754 technical committees SAC / SC, 11 standardization working groups SAC / SWG, and 1314 existing standard committees. The measures for the administration of medical device standards stipulates that the State Drug Administration shall, according to the needs of medical device standardization, establish a medical device Standard Committee upon approval. For the professional technical fields that the existing medical device standard committee cannot cover, the State Drug Administration may, according to the regulatory needs, determine the centralized technical unit for Medical Device Standardization (hereinafter referred to as the centralized unit-CU). Now China has formed the organizational structure composed of the technical Committee, the sub Technical Committee and the centralized unit.

Contact for detailed info and statistics of:

  • TC, SC, CU
  • Membership
  • Voting process