Decree 13 Guideline For Acceptance Of Overseas Clinical Trial Data

CFDA Announcement No. 13 in 2018, Issued on Jan 18, 2018
Guideline for Acceptance of Overseas Clinical Trial Data
To fulfill the clinical need of publics for medical devices, and to 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 (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
The guideline is applicable to guide to work that applicants use clinical trial data as clinical evaluation
material during medical device (including in vitro diagnostic reagents) registrations in China.
The overseas clinical trial data in this guideline refers to the research data generated completely or
simultaneously in the overseas clinical trials filling 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 clinical trial data
A. Ethic principle
Overseas clinical data shall follow the ethical principles of the “Declaration of Helsinki”. The applicants
shall describe the norms and standards of the ethics, laws and regulations in the countries (regions)
where the clinical trials are conducted, or the international norms and standards.
B. Legal principle
The overseas clinical trial should be conducted in the countries (regions) that have the quality
management of clinical trials and meets the regulatory requirements for clinical trials of medical devices
(including IVD reagents) in China. If the quality management regulations that the clinical; trial complies
are different from Medical Device Good Clinical Practices (GCP) in China, the differences shall be
described in detail, and it shall be fully proved that the differences do not affect the authenticity,
scientificity, reliability and traceability of trial data, and can guarantee the rights and interests of the
subjects. The applicant and the clinical trial sites shall be supervised by the CFDA.
C. Scientific principle