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CFDA Issues New Rules on Medical Device Clinical Trial Institutions

The Administrative Provisions on the Qualifications and Record Filing of Clinical Trial Institutions for Medical Devices jointly issued by the China Food and Drug Administration (CFDA) and the National Health and Family Planning Commission (NHFPC) will take effect on 1 January 2018. Under new provisions, qualified medical device clinical trial institutions must be above level 2A and have their own administrative department, staff and administrative system. The provisions also specify the record filing procedures and the information and documentation required for registration. Medical device clinical trial institutions may log on to the “medical device clinical trial institutions record filing system” on the CFDA website (www.cfda.gov.cn) to complete the required formalities.

For further details (in Chinese), please refer to the following link:

Announcement on the Issuance of Administrative Provisions on the Qualifications and Record Filing of Clinical Trial Institutions for Medical Devices (No. 145 [2017])

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