On 31 March 2014, Chinese government released the revised
Regulations on the Supervision and Administration of Medical
Devices ("Revised Regulations"). The Revised Regulations
will come into effective on 1 June 2014, presenting following major
Classification and Supervision System
According to the Revised Regulations, medical devices are still
supervised and managed under a Class I, Class II and Class III
system based on the risk to the users. However, the supervisory
system has been changed with below highlights.
Class I medical devices no longer need a prior registration and
a record-filing with the relevant municipal FDA is sufficient.
Class II and III medical devices still require a prior registration
but for subsequent changes, only a record-filing instead of
previous registration modification is required if such changes are
Clinic Trials Approval
Clinic trials of Class II medical devices no longer need a prior
approval as required before. For clinic trials of Class III medical
devices, the prior approval is required only for the ones
accompanying high risk to human body.
Class I medical device distribution company does not need to
complete a record-filing as required before. Class II distribution
company no longer needs a prior approval and a record-filing with
the relevant municipal FDA is sufficient. Class III distribution
company still needs to go through examination and approval
procedures and obtain the Medical Device Distribution License.
Other main modifications include the cancellation of the
approval for medical devices research and development by medical
institutions, the cancellation of the compulsory safety
certification requirement previously implemented for part of Class
III medical devices and etc.
Manufacturing Supervision Adjustment
Medical Device Registration before Manufacturer
According to the Revised Regulations, manufacturers shall submit
the medical device registration certificate when applying for the
Although not expressly provided in the Revised Regulations,
according to explanations from CDFA officials, medical device
manufacturers are allowed to complete medical device registration
before obtaining the manufacturing license, which means medical
device manufacturers might speed up manufacturing process with a
prior completed medical device registration.
However, according to the Revised Regulations, Good
Manufacturing Practice ("GMP") documents with respect to
product research and development and manufacturing is required for
medical device registration, it is likely that at least a
preliminary GMP system shall be established at the time of
GMP Compliance Requirement
GMP compliance requirement of medical device manufacturers is
expressly provided in the Revised Regulations and medical device
manufacturers must establish and operate the system, and
periodically report self-evaluation results to the relevant
Contract Manufacturing Provision
The Revised Regulations explicitly set forth an article with
respect to contract manufacturing, according to which, entrusting
party shall be responsible for the quality of the medical device
and entrusted party shall be a medical device manufacturer that is
in full conformity with the Revised Regulations and is equipped
with corresponding manufacturing conditions. In addition,
implantable medical device with high risks are prohibited to be
produced under a contract manufacturing model.
In addition, the Revised Regulations impose more obligations on
institutions using the medical devices by imposing obligation of
safety management of medical devices, enhance control over daily
administration and regulate supervisory activities by establishing
a monitoring system of adverse event of medical devices and a
re-evaluation system of registered medical devices (and etc.),
emphasize liabilities by refining the penalties, adjusting the
range, and increasing types and intensity of penalties for
After the promulgation of the Revised Regulations, Chinese
government has promulgated a series of draft of relevant rules and
regulations soliciting comments from public, which covers various
perspectives of the supervisory system of medical devices, e.g. the
management of registration and filing, supervision of production,
operation and quality of use, the classification rules and etc.
Together with the Revised Regulations, they will establish a new
legal regime of China's supervision of medical devices upon
effectiveness. KWM lawyers will keep close attention to relevant
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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