CFDA and NHFPC jointly issue the Good Clinical Practice for medical devices 

2016-03-24

Chapter 1 General

Article 1. The practices are established according to the Regulations for the Supervision and Administration of Medical Devices, in order to strengthen the management of medical devices clinical trials, safeguard the rights and interests of the subjects during medical devices clinical trials, as well as to ensure the standardization of the process of medical devices clinical trials, the authenticity, scientificity, reliability and traceability of the test results.

Article 2. For all the medical devices clinical trials carried out within the territory of the people's Republic of China , the practices should be followed.

The practices cover the whole process of medical devices clinical trials, including designing, implementing, monitoring, verifying, inspecting, as well as data collecting, recording, analyzing and summarizing and reporting.

Article 3. The medical devices clinical trials mentioned in the practices refers to the process that the medical device applied for registration is carried out safety and efficacy validation and verification in an accredited clinical trial institution.

Article  4.  The  medical  devices  clinical  trials  shall  comply  with  the  legal

administration principles, ethical principles and scientific principles.

Article 5. The provincial level or above Food and Drug Administration Departments shall be in charge of the supervision and management of medical devices clinical trials.

The related Health and Family Planning Departments shall strengthen, within their responsibilities, the management of medical devices clinical trials.

The Food and Drug Administration Departments and the Health and Family Planning Departments should establish an information reporting mechanism for medical devices clinical trials quality management, so as to strengthen the information reporting on the approval of clinical trials of class III medical devices and those included in National Large Medical Equipment Management Items List, as well as the related supervision and administration information on clinical trials.

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