CFDA Accept Medical Device Oversea Clinical Trial Data (Exposure Draft)

November 14th 2017, China Food and Drug Administration (CFDA) issued the regulation ‘Accept Medical Device Oversea Clinical Trial Data Technical Guideline (exposure draft)’. CFDA encourages public to make suggestions before December 13th 2017 through Email (jushan@cmde.org.cn).

Applicable subjects
This guideline can apply to the medical device that the applicant uses the oversea clinical trial data for the clinical evaluation during China registration application. The oversea clinical trial data in this guideline stands for the clinical trial data for confirming the safety and effectiveness of the medical device in normal operating situation.

Attachment : The original Chinese version regulation ‘Accept Medical Device Oversea Clinical Trial Data Technical Guideline (exposure draft)’.

*If you have any comments or questions, please contact us at md@cirs-group.com.

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