CFDA Announcement No. 13 in 2018, Issued on Jan. 18, 2018
Outline:
To fulfill the clinical need of public for medical devices, improve the innovation of medical device technology, this guideline is made according to the “Opinions on reforming the review and approval system to encourage the innovation of drugs and medical devices” by the General Office of the Central Committee of the CPC and the General Office of the State Council (GO [2017] No.42), and the relevant regulatory requirements of medical devices in China. This guideline is to provide technical guidance for applicants using overseas clinical trial data for registration and for authorities reviewing these data, to avoid or reduce redundancy of clinical trials and to facilitate medical devices marketing process in China.
I. Scope
This guideline is applicable to guide the work that applicants use overseas clinical trial data as clinical evaluation material during medical device (including in vitro diagnostic reagents) registration in China.
The overseas clinical trial data in this guideline refers to the research data generated completely or simultaneously in the overseas clinical trial sites fulfilling the requirements of the countries (regions), in the verification process for the safety and effectiveness of the medical device to be registered in China.
II. Principles of acceptance of overseas clinical trial data
III. Requirements for the submission and the acceptance of overseas clinical trial data
IV. Factors and technical requirements to accept overseas clinical trial material
Download the full text here:
Guidelines for Acceptance of Overseas Clinical Trial Data
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