Measures for the Supervision and Management of Medical Device Operation
Chapter I
General Principles
Article 1
These measures are specially formulated to strengthen the supervision and
management
of
medical
device
operation,
standardize
the
operating
behaviors
of
medical
devices,
and
guarantee
the
safety
and
validity
of
medical
devices
in
accordance
with
the
Regulations
on
the
Supervision
and
Administration
of
Medical
Devices
.
Article
2
The
operating
activities
and
their
supervision
and
management
of
the
medical
devices
dealt
with
within
the
territory
of
the
People's
Republic
of
China
should be governed by these measures.
Article 3
China Food and Drug Administration shall be in charge of the supervision
and
management
of
the
medical
device
operation
nationwide.
The
food
and
drug
administration department above county level shall be responsible for the supervision
and management on the medical device operation within respective jurisdiction.
Higher-level
food
and
drug
administration
department
shall
be
responsible
for
directing
and
supervising
the
supervision
and
management
on
the
medical
device
operation conducted by lower-level food and drug administration department.
Article 4
Classified management shall be implemented for medical device operation
according to the risk level of medical device.
The operation of Class I medical devices may be exempted from licensing and filing;
filing management shall be implemented for the operation of Class II medical devices;
and licensing management shall be implemented for the operation of Class III medical
devices.
Article
5
China
Food
and
Drug
Administration
shall
formulate
the
good
supply
practice for medical devices and supervise the implementation.
Article
6
Food
and
drug
administration
department
should
timely
publish
the
information on the licensing and filing for medical device operation according to law.
Applicant may inquire about the progress and results of examination and approval and
the public may look up the examination and approval results.
Chapter II Operation Licensing and Filing Management
Article
7
Applicant
dealing
with
medical
device
operation
should
meet
the
following conditions:
(I)
Possess
the
quality
management
institution
or
quality
management
personnel
appropriate
to
the
operating
scale
and
business
scope;
the
quality
management
personnel
should
have
the
professional
educational
background
or
technical
title
in
relevant disciplines recognized by the state;