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CFDA Adjusts Administrative Approval Procedures for Medical Devices

In a bid to optimise the workflow and efficiency of the evaluation and approval of medical devices, the Decision of the China Food and Administration (CFDA) on Adjusting Some Administrative Approval Procedures for Medical Devices (CFDA Order No.32) will take effect on 1 July 2017.

After the adjustment, the following administrative approval decisions for medical devices now made by CFDA shall be made by the Center for Medical Device Evaluation (CMDE) under CFDA on behalf of CFDA:

  1. Decision on granting approval to clinical trials for class III high-risk medical devices;
  2. Decision on granting approval to change of permission items for China-made class III medical devices and imported medical devices; and
  3. Decision on granting approval to registration renewal for China-made class III medical devices and imported medical devices.

For other medical devices, the decision to approve application for registration is made by CFDA under existing procedures.

After the adjustment, approval decisions will be issued by the person in charge of the CMDE.

See website of CFDA for details in Chinese.


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