Decree 25 Good Clinical Practice For Medical Devices

Chapter 1 General provisions
Article 1 The Practice is formulated in accordance with the Regulations on the
Supervision and Administration of Medical Devices in order to further
strengthen the management of clinical trials of medical devices, protect the
rights and benefits of trial subjects and assure the clinical trial procedure
standard, truthful, scientific, reliable and traceable.
Article 2 All the clinical trials of medical devices within the territory of the
People’s Republic of China shall be conducted according to the practice. The
Practice covers the whole procedure of clinical trial of medical devices,
including the protocol design, conduction, monitoring, audit, inspection,
collection of data, record, analysis and summary and report of clinical trial, etc.
Article 3 Clinical trial of medical devices mentioned in this Practice refers to the
process of confirming and verifying the safety and efficacy of the medical
device intended to apply registration under normal condition in qualified
clinical trial institutions of medical devices.
Article 4 Clinical trials of medical devices shall comply with the principle of
legal, ethic and science.
Article 5 Food and drug regulatory authority above province level are
responsible for the supervision and management of clinical trails of medical
devices.
The competent department of National Health and Family Planning
Commission shall strengthen the management of clinical trails of medical
devices within the scope of its duties.
Food and drug regulatory authority and the competent department of NHFPC
shall establish the information notification system on quality management of
medical device clinical trials and strengthen the information notification on the
approval for conducting clinical trial of Class III medical devices and the medical
devices listed in the management catalog of large medical equipment
collocation in China and the data of the supervision and management on
relevant clinical trial.
Chapter II Preparation before clinical trials
Article 6 There should be sufficient scientific basis and clear trial purpose to
conduct clinical trials of medical devices, and the expected benefits and risks to
the health of subjects and public shall be weighed, the expected benefits
should exceed the possible damage.
Article 7 Before clinical trial, the sponsor shall complete the pre- clinical study
of investigational medical devices, including the design of products (structure
and composition, working principle and mechanism of action, intended use,
application scope and applicable technical requirements) and quality inspection,
animal trial and analysis report, etc, and the results shall support the clinical
trial. The results of quality inspection include report of self-inspection and the
qualified report for registration inspection issued by a qualified inspection
agency within one year.
Article 8 Before clinical trial, the sponsor shall prepare adequate investigational
medical devices. The development of investigational medical devices shall meet
relevant requirements of quality management system of medical devices.
Article 9 Clinical trials of medical devices shall be conducted in two or more
than two clinical trial institutions of medical devices. The selected trail
institution shall be qualified clinical trial institution of medical devices and the
facilities and conditions shall meet the requirements for conducting clinical
trials safely and effectively. The investigator should have the professional
expertise, qualifications and ability to undertake the clinical trial and should
have been trained.
Administrative measures for the qualification recognition of clinical trial
institutions of medical devices shall be formulated separately by China Food
and Drug Administration and National Health and Family Planning Commission
of China.
Article 10 Before clinical trial, the sponsor, clinical trial institution and
investigator shall make a written agreement on trial design, quality control of
trial, division of responsibilities in the trial, the cost of clinical trials undertaken
by the sponsor and the treatment principle of injuries that may occur in the
trial.
Article 11 Clinical trials should be approved by ethics committee of clinical trial
institutions. Medical devices listed in the directory of Class III medical device
clinical trial shall also be approved by CFDA.
Article 12 Before clinical trial, the sponsor should file to local food and drug
regulatory authority of the province, the autonomous region or the
municipality directly under the Central Government.
The food and drug regulatory authority accepting the filling should report the
filing situations to the food and drug regulatory authority and the competent
authority of NHFPC in the same level where the clinical trial institution is
located.
Chapter III Protection of rights and benefits of trial subjects
Article 13 Clinical trials of medical devices should be conducted in accordance
with the ethical principles in World Medical Association Declaration of Helsinki .
Article 14 Ethical review and informed consent are the main measures to
protect the rights and benefits of subjects. Each party involved in the clinical
trial shall undertake corresponding ethical responsibilities according to their
duties in the trial.
Article 15 The sponsor should avoid to cause undue influence or misleading to
subjects, clinical trial institutions and the investigator and other clinical trial
participants or related parties.
Clinical trial institution and the investigator should avoid to cause undue
influence and misleading to subjects, the sponsor and other clinical trial
participants or related parties.
Article 16 The sponsor, clinical trial institution and the investigator shall not
exaggerate the compensation measures for participating in clinical trials and
mislead the subjects to participate in clinical trials.
Article 17 Before clinical trial, the sponsor shall submit the following
documents to ethics committee through the investigator and the management
department of medical device clinical trial of clinical trial institution:
(1) Protocol of clinical trial;
(2) Investigator’s brochure;
(3) Text of informed consent form and any other written documents provided to
subjects;
(4) Procedural documents for recruiting subjects and publicity;
(5) Text of case report form;
(6) Self-inspection report and the inspection report for product registration;
(7) Resumes, professional expertise, ability, training of the investigator and
other documents to prove qualifications;
(8) Overview of the facilities and conditions of clinical trial institution meeting
trial;
(9) Declaration that the development of investigational medical devices meet
relevant requirements of applicable quality management system of medical
devices;
(10) Other documents related to ethical review.
Ethics committee should uphold the principles of ethics and science, review and
supervise the implementation of clinical trials.
Article 18 If one of the following cases occur during the clinical trial, the
investigator shall report in time to the management department of medical
device clinical trial of clinical trial institution, inform the sponsor and report the
ethics committee through the management department:
(1) Serious adverse events;
(2) Report of progress, including summary for safety and report of deviation;
(3) For any revise for the approved documents by ethics committee, the non
substantive changes that do not affect the rights and benefits, safety and health
of subjects or is not related to the purpose or endpoint of clinical trial don’t
need to be reported in advance, but shall be notified in written form afterwards.
(4) Suspension, termination or requiring for restoring the clinical trial after
suspension;
(5) deviation of clinical trial protocol affecting the rights and benefits, safety
and health of subjects or the scientific nature.
In order to protect the rights and benefits, safety and health of subjects, the
deviation in an emergency that can’t be reported in time shall be reported as
soon as possible in written form afterwards according to relevant provisions.
Article 19 In the process of clinical trial, in the cast that revising the clinical trial
protocol, informed consent form and other documents, requiring for deviation
and restoring the suspended clinical trial, the trial shall continue to be
implemented after being approved by the ethics committee.
Article 20 The minors, pregnant women, old people, persons with mental
disability, patients in danger and others shall be avoided to be chosen as
subjects; if they are needed to be chosen for some necessary reason, relevant
additional requirements provided by the ethics committee shall be complied
with, and the special design shall be conducted for their health conditions in
the clinical trial and it shall be helpful to their health.
Article 21 Before the subjects’ participating in the clinical trial, the
investigator shall explain the details of clinical trial to the subjects,
the guardians of persons without or with limited capacity for civil conduct,
including recognized, foreseeable risks and possible adverse events, etc.The
subjects and guardians shall sign their name and the date on the informed
consent form after sufficient and detained explanation, and the investigator
shall also need to sign his name and the date.