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• Posted May 27 , 2018

CFDA Announces Technical Guidance for Accepting Overseas Clinical Data of Medical Devices

Source: China Medical Science and Technology Network & China Food and Drug Administration (CFDA)

Note: Content may be edited for style and length

On 11th January, 2017, the CFDA issued the Notice on Issuing the Technical Guidance for Accepting Overseas Clinical Data of Medical Devices (Guiding Principles). The purpose is:

to provide the technical guidance for applicants who apply for the registration with clinical trial data of medical devices from overseas;

to provide the technical guidance for the regulatory authorities on the review of such clinical trials;

to avoid or reduce repetitive clinical trials;

to speed up the process of listing medical devices in China.

The Guiding Principles are used to guide the accepting overseas clinical trial data as clinical evaluation data when applicants apply for the registration of medical devices in China.

The Guiding Principles put forward the following: accepting the ethical principles, the principle of legality and the scientific principles of overseas clinical trial data and clarifying the data requirements and technical requirements of overseas clinical trial data.

The Guideline Principles set forth the considerations and technical requirements for accepting information from overseas clinical trials in terms of the technical review requirements, the population to be tested and the differences in clinical trial conditions, and also provide specific examples which illustrate impacts of different factors on clinical data and clinical significance.

Attachment: Technical guidelines for accepting overseas clinical trials data of medical devices 

In order to better meet public needs for medical devices and to promote technological innovation in medical devices, CFDA has formulated the Guiding Principles according to the opinions of the CPC Central Committee General Office and the General Office of the State Council on Deepening the Reformation of Examination and Approval System and Encouraging the Innovation of Medicine and Medical Devices (Office [2017] No. 42) and the registration management-related requirements of medical device in China.

1. Scope

The Guideline Principles are applicable to guide when applicants apply for the registration of medical device (including in vitro diagnostic reagents) in China, the clinical trial data from foreign clinical trials can be accepted as the clinical evaluation data. The clinical trial data referred to by theGuideline Principles are research data generated from clinical trials carried out by organisations with required clinical trial conditions in their countries (or regions) as well as research data which are produced under normal operations by those medical instruments which are to be registered in China and of which the safety and effectiveness are confirmed during the process.

2. The basic principles for accepting overseas clinical trial data 

(A) Ethical principles

Clinical trials abroad should be conducted following the codes of ethics that has been set in the Helsinki Declaration of World Medical Congress. Applicants also need to describe the ethics, laws, norms and standards, or international norms and standards in these countries/(regions), where clinical trials are carried out.

(B) The principle of law

Overseas clinical trials should be carried out in these countries/ (regions) that have quality control of clinical trials. It complies with the regulatory requirements for clinical trials of medical devices (including in vitro diagnostic reagents) in China. If a clinical trial is compliant with the quality management documents of clinical trial, but is different from the Clinical Trial of Medical Devices Differences in Quality Management Practices (GCPs), it should be described in details about the contents of the differences and demonstrated that the differences do not affect the authenticity, scientificity, reliability and traceability of research results and do have a guarantee to the rights and interests of the participants. Applicants and clinical trial institutions should be supervised and inspected by the State Food and Drug Administration.

(C) The principle of science

Overseas clinical trials data should be truthful, scientific, reliable and traceable. Applicants should provide complete experimental data and are not allowed to present selected data.

Applicants should ensure that purpose of a clinical trial abroad is appropriate, that the experimental design is scientific and reasonable and that the experimental conclusion is clear. The rights and interests of subjects are protected and the possible risks to other personnel are controlled.

3. The submission of overseas clinical trial data and acceptance requirements

Applicants should submit overseas clinical trial information that should at least include: clinical trial program, ethical advice and clinical trial reports. A clinical trial report should include analyses and conclusions of complete clinical trial data.

Based on the clinical evaluation paths selected by applicants for the registration of a medical device, data from overseas clinical trials can be used as clinical trial data and can also be used as verification data to prove that differences between the same types of instruments do not adversely affect the safety and efficacy of the device.

When applicants use multicentre clinical trial data which are carried out in China and overseas during a same period as the registration declaration data, they should clarify rationales for the distribution of the number of cases borne in China in order to further evaluate whether they meet the relevant requirements for the registration in China.

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