Technical Guideline for Acceptance of Data Derived from Overseas Clinical Trials of Medical Devices
In order to better meet the public's clinical needs for medical devices and promote technological innovation in medical devices, according to the Opinions on Deepening the Reform of Review and Approval System and Encouraging Innovation of Drugs and Medical Devices (Office  No. 42) issued by General Office of the CPC Central Committee and General Office of the State Council as well as the national requirements for medical device registration management, this Guideline is hereby formulated. This Guideline is intended to provide technical guidance for applicants to apply for registration using data derived from overseas clinical trials of medical devices and for supervision authorities to review such clinical trial data, to avoid or reduce repetitive clinical trials and speed up marketing of medical devices in China.
This Guideline is applicable to guiding the acceptance of data derived from overseas clinical trials of a medical device (including IVD reagent) as the materials for clinical evaluation, when the applicant applies for registering the medical device in China.
The overseas clinical trial data involved in this Guideline refer to the research data generated during the validation of the safety and effectiveness of the medical device intended for registration in China under normal use conditions, by qualified clinical trial institutions in the country (region) where the clinical trial is carried out in the whole or same period.