Good Clinical Practice (GCP) for Medical Device in China

In order to strengthen the management of clinical trial of medical device, guarantee the subjects’ rights and interests, and ensure that the process of clinical trial is standardized, and the result is authentic, reliable and traceable, CFDA has formulated and issued Good Clinical Practice for Medical Device with National Health and Family Planning Commission on Mar 23^th, 2016. This regulation will come into force from Jun 1^st, 2016.
It is generally known that clinical trial is one of the important ways to determine the safety and effectiveness of medical device. So CFDA has emphasized on the following content in GCP.
1. Define the duties and roles of the sponsor, clinical trial institutions and researchers, and administration department of clinical trial clearly. Emphasize that sponsor is responsible for clinical trial management, and detail the duties and responsibilities of clinical trial institution and researchers.
2. Strengthen the protection of right and interest for subjects, improve the related management system and requirement, and highlight the role of ethics committee and informed consent of subjects. If these are accidental injury or death in clinical trial, sponsor is required to pay the fee of treatment and relevant economic compensation.
3. Strengthen and stress the management of clinical trial risk, and define the clinical trial suspend and termination mechanism. Implement sponsor’s body responsibility to ensure the safety and controllability of clinical trial.
The main content of GCP
GCP is composed of nine chapters, or ninety six articles, which cover all process of medical device clinical trial, such as project design, implementation, supervision, inspection, examination, data collection, conclusion analysis and report, etc.

Chapter I General is composed of five articles, which defines the legislative intent and basis, application scope, and duties and responsibilities of administration departments.
Chapter II Pre-trial Preparation is composed of seven articles, which defines the hardware and software condition of medical device clinical trial launch, stipulates the requirements of institution review board (IRB), administration examination and approval, clinical trial possession record.
Chapter III Subjects’ right protection is composed of thirteen articles, which makes specific rules about subjects’ right protection.
Chapter IV Clinical trial project is composed of four articles, which makes specific rules about clinical trial project formulation, content and revision. Define that the sponsor is the organizer of clinical trial project formulation, as well as multi-center clinical trial definition and specific requirements.
Chapter V Ethics committee responsibility is composed of eight articles, which states the ethics committee composition, establishment, work procedure, duty and responsibility, etc. and makes a stipulation that ethics committee has the power to suspend or terminate clinical trial to protect subjects.
Chapter VI Sponsor responsibility is composed of twenty one articles, which makes specific rules about sponsor’s duties and responsibilities, and stipulate the clinical research associate and inspector selection, working scope and responsibilities. Sponsor is responsible for authenticity of clinical trial and safety of tested medical device.
Chapter VII Clinical trial institution and researcher responsibility is composed of twenty one articles, which makes specific requirements about clinical trial institution and researcher responsibility. Stipulating the researcher’s qualification, and define the responsibility of clinical trial institution and research.
Chapter VIII Record and report is composed of seven articles, which states the requirements of clinical trial record and report.
Chapter IX Tested medical device management is composed of three articles, which stipulates the requirements of tested medical device mark, record and use.
Chapter X Basic document management is composed of three articles, which stipulates the requirements of storage of related documents.
Chapter XI Supplementary is composed of four articles, which stipulates the definition of certain terms, and state the requirement of particular subjects.

Further information
The first batch of medical devices exempted from clinical trial in China.
The second batch medical devices exempted from clinical trial in China (Exposure draft).
Clinical trial application Fee of medical devices with very high risk level

If you need the English version of Good Clinical Practice for Medical Device, please contact us.

Ms. Windy Jin,
Medical Device Legislation Compliance Deportment, CIRS China;
11F Dongguan Building, 288 Qiuyi Road, Binjiang District, Hangzhou, China, 310020
Email: Windy@cirs-group.com

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