Comments on the CFDA's "Modification of Administrative Approval"

2017-02-06 | Beijing

The Healthcare Equipment Working Group submitted comments to the CFDA's draft "Modification of Administrative Approval for Medical Devices"

The working groups welcomes this modification and expects that they will lead to an accelerated market approval of medical devices.

The working groups recommends that administrative approval by the CMDE is extended to additional approvals, e.g. modification of instructions for use. 

The working group recommends that the final regulation should include a definite timeframe for administrative approvals.

More information: http://www.cfda.gov.cn/WS01/CL0783/168140.html