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CHINA: CFDA publishes the notice on examination of medical device - January 2018

CHINA: CFDA publishes the notice on examination of medical device - January 2018

  • 2020-02-14 14:54:11

Before undergoing registration application in China, medical devices shall be sent to medical device inspection agencies for examination to ensure that the products meet national standards. CFDA has issued a notice on the examination work to ensure the efficiency of registration of medical devices. The details of the notice are as follows:

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China: CFDA releases the interpretation of the basic requirements of the clinical evaluation for IVD reagents exempt from the clinical trials - December 2017

China: CFDA releases the interpretation of the basic requirements of the clinical evaluation for IVD reagents exempt from the clinical trials - December 2017

  • 2020-02-14 15:22:02

The Clause 29th of "The Guidance of Registration for In-vitro Diagnostic Reagent” clarifies that for in-vitro diagnostic (IVD) reagents exempt from clinical trial, the applicant is responsible for the evaluation of the clinical performance of the IVD reagents by means of evaluating the clinical samples from the intended use, interference factors, comprehensive literatures and other pre-clinical data.

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