On March 23, 2016, the China Food and Drug Administration
(“CFDA”) and the National Health and Family Planning
Commission jointly promulgated the final revision to the 2004
Medical Device Clinical Studies Rules
(“MDCSR”), the first ever revision in almost 12 years.
The revision, titled Good Clinical Practice for Medical
Devices (“Device GCP”), will become effective as
of June 1, 2016.
A medical device clinical study defined in this Device GCP only
refers to registration studies intended for obtaining regulatory
approvals. Notably, this Device GCP does not apply to in vitro
diagnostic reagents that are classified as medical devices.
The revised Device GCP contains 11 chapters and 96 articles,
significantly expanding the current MDCSR’s 29 articles. It
sets forth general principles, as well as guidance regarding
preparation before the clinical study, protection of
subjects’ rights, the clinical trial protocol,
responsibilities of ethics committees/sponsors/investigators/sites,
retention and documentation of records and reports, management of
the study device, and source document management. Highlights of the
Device GCP are as follows:
Clarifying the Definition of Sponsors: A
sponsor refers to the party who is responsible for the initiation,
management and monitoring of a clinical study. The current MDCSR
defines a sponsor of a clinical study as the applicant who submits
the device registration application, while the Device GCP clarifies
that a sponsor shall be a device manufacturer. If the sponsor is a
foreign entity, such sponsor shall designate a Chinese company as
Strengthening the Responsibilities of
Sponsors: Sponsors are responsible for monitoring the
study and shall appoint qualified monitors to perform monitoring
activities. In addition, if there is any information affecting the
study, the sponsor is responsible for revising the investigator
brochure, and obtaining an approval from the ethics committee for
Detailing the Requirements for Seeking Informed
Consent: The Device GCP specifies what types of
information must be included in an informed consent form and how to
obtain informed consent from study subjects. Any revised informed
consent forms must be approved by the ethics committee prior to its
communication with study subjects. As long as the revision can
potentially affect the subjects’ willingness to participate
in the study, the sponsor must seek subjects’ further
Clarifying the Validity of the Registration Test
Report: The study device must pass the registration type
test conducted by a qualified testing center, and such type test
report must be issued within a year.
Specifying the Requirements for Multicenter
Studies: According to the Device GCP, a multicenter study
is defined as a study conducted according to a single protocol but
at more than three sites. The ethics committee of the lead site
shall conduct an ethics review of the protocol on behalf of all
study sites. The participating sites may review the feasibility of
conducting the study within the site, but generally will not
propose any revisions to the protocol. The principal investigator
of the lead site will become the coordinating investigator. In
addition, both the coordinating investigator and the sponsor are
responsible for the implementation of the entire study.
Imposing Stringent Records Retention
Requirements: The Device GCP stipulates that the study
sites must keep all clinical data and materials for a period of ten
years after the completion of the study. The sponsors must keep
records of the study until all of the devices are no longer in
Reiterating the Study Recordation
Requirements: Reinforcing the Regulations on the
Supervision and Management of the Medical Device (also known
as the Order #650), the Device GCP stipulates that sponsors shall
file for the recordation of their device studies with the local
FDAs at the provincial level prior to launching any studies.
The Device GCP will strengthen the administration of device
registration studies in China. Companies intended to launch new
devices in China are advised to review their current practices and
upgrade their compliance standards to the extent necessary.
The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
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