Home About Qualtech NEWS CHINA: NMPA Issues Judging Principles for On-site Inspection of Clinical Trials for Medical Devices – January 2019
CHINA: NMPA Issues Judging Principles for On-site Inspection of Clinical Trials for Medical Devices – January 2019

January 15, 2019

In order to facilitate the effective supervision of clinical trial processes for medical devices, the China National Medical Product Administration (NMPA) has officially passed on "The Judging Criteria for On-site Inspections of Clinical Trials for Medical Devices” which start to implement in the end of November 2018.

This notice was written in accordance with the core regulations which serve to regulate the on-site inspections of clinical trials for medical devices, namely: "Measures for the Administration of Medical Device Registration" and the "Quality Management Regulations for Medical Device Clinical Trials”.

The notice includes the following chapters:

I. Checkpoints of on-site inspection: This explains the checkpoints to be noted at each stage of clinical trial, and proposes the specific details of the inspection which manufacturers should pay attention to, including “pre-clinical trial preparation”, “protection of subject’s rights”, “clinical trial protocol”, “conducting clinical trials”, “records and reports”, and “management of medical device for clinical trials”.

II. Judging Principles: In this chapter, several principles are listed to determine which case falls on the authenticity issue and which case falls on the compliance issue.

 

Reference:

Official press

 

 

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Home About Qualtech NEWS CHINA: NMPA Issues Judging Principles for On-site Inspection of Clinical Trials for Medical Devices – January 2019