|
Regulations
for the Supervision and Administration of Medical Devices
Chapter
1 General Provisions
Article
1 These
Regulations are hereby formulated with a view to strengthening
the supervision and administration of medical devices,
ensuring their safety and effectiveness and protecting human
health and life safety.
Article
2 All
units or individuals engaged in the research and development,
production, distribution, use, supervision and administration
of medical devices within the territory of the People's
Republic of China shall comply with the Regulation.
Article
3 "Medical
devices" as defined by these regulations refers to: any
instrument, apparatus, appliance, material, or other article
whether used alone or in combination, including the software
necessary for its proper application. It does not achieve its
principal action in or on the human body by means of
pharmacology, immunology or metabolism, but which may be
assisted in its function by such means; the use of which is to
achieve the following intended objectives:
1. Diagnosis,
prevention, monitoring, treatment or alleviation of disease;
2. Diagnosis,
monitoring, treatment, alleviation of or compensation for an
injury or handicap conditions;
3. Investigation,
replacement or modification for anatomy or a physiological
process;
4. Control
of conception.
Article
4 The
drug regulatory authority under the State Council is
responsible for supervision and administration of medical
devices nationwide. The drug administration of the local
government at county level and above is responsible for
supervision and administration of medical devices in each
administrative region. The drug regulatory authority under the
State Council shall coordinate with other departments under
the State Council, responsible for comprehensive economic
administration, in the implementation of policies for the
medical device industry.
Article
5 The
State shall classify medical devices and administer them based
on this classification
Class
I Medical Devices are those for which safety and effectiveness
can be ensured through routine administration;
Class
II Medical Devices are those for which further control is
required to ensure their safety and effectiveness
Class
III Medical Devices are those which are implanted into the
human body, or used for life support or sustenance, or pose
potential risk to the human body and thus must be strictly
controlled in respect to safety and effectiveness.
The
classification catalogue for medical devices shall be
stipulated, adjusted and promulgated by the drug regulatory
authority under the State Council, in accordance with
classification principles after consulting with health
authority under the State Council.
Article
6 Medical
devices produced and used for the purpose of providing
concrete measuring values shall comply with the requirements
of the metering law. The detailed product list shall be
formulated and promulgated by the drug regulatory authority
under the State Council, jointly with the metering authority.
Chapter
2 The Administration of Medical Devices
Article
7 The
State encourages the research and development of new medical
devices. "New medical devices" refer to the kind of
brand new product varieties which have not been available in
the domestic market, or for which the safety, effectiveness
and product mechanism have not been recognized domestically.
The
clinical trials of new medical devices of Class II and Class
III can be conducted only after clinical trial approval by the
relevant authority in accordance with the rules of the drug
regulatory authority under State Council.
New
medical devices that have completed clinical trials and passed
experts' evaluation and review organized by the drug
regulatory authority under State Council, shall receive a new
product certificate after being approved by the same
organization.
Article
8 The
State shall implement a product registration system for the
manufacturing of medical devices.
Class
I medical devices shall be inspected, approved and granted
with a registration certificate by the drug regulatory
authority of the government of the municipalities consisting
of districts.
Class
II medical devices shall be inspected, approved and granted
with registration certificates by the drug regulatory
authorities of provinces, autonomous regions and
municipalities directly under the central government.
Class
III medical devices shall be inspected, approved and granted
with registration certificates by the drug regulatory
authority directly under the State Council.
Clinical
evaluation must be conducted for Class II and Class III
medical devices before they are put into production.
Article
9 The
drug regulatory authorities of provinces, autonomous regions
and municipalities directly under the central government are
responsible for the inspection and approval of the clinical
trial or verification of class II medical devices in their own
administrative regions. The drug regulatory authority under
the State Council is responsible for the inspection and
approval of clinical trial or verification of class III
medical devices.
Clinical
trial or verification shall be conducted in the medical
institutions designated by the drug regulatory authorities of
the government at provincial level and above. The medical
institutions shall conduct the clinical trial or verification,
in accordance with the related provisions of the drug
regulatory authority under the State Council.
The
qualification of medical institutions engaged in the clinical
trial or verification shall be certified by the drug
regulatory authority, jointly with the health authority under
the State Council.
Article
10 Medical
institutions may develop medical devices to serve their own
clinical needs, and use them within their own institution
under the guidance of licensed medical practitioners.
Class
II medical devices developed by medical institutions shall be
inspected and approved by the drug regulatory authority of the
government at provincial level and above. Class III medical
devices developed by medical institutions shall be inspected
and approved by the drug regulatory authority under the State
Council.
Article
11 When
importing medical devices into China for the first time, the
agent of the imported device, should submit the instruction
for use, quality standards, testing methods, other relevant
information, product samples, and marketing authorization
certificates issued by the manufacturing countries (regions),
for inspection and approval by the drug regulatory authority
under the State Council, and receive an import product
registration certificate before applying for customs
formalities.
Article
12 When
applying for registration of medical devices, technical
standards, testing report and other relevant information shall
be submitted according to provisions of the drug regulatory
authority under the State Council.
The
drug regulatory authority of the government of the
municipality consisting of districts shall decide within 30
working days if the product can be registered, counting from
the date of acceptance of the application. For those not
approved for registration, a written explanation shall be
given to the applicant.
The
drug regulatory authority of governments of provinces,
autonomous regions and municipalities directly under central
government shall decide within 60 working days if the product
can be registered, counting from the date of acceptance of the
application. For those not approved for registration, a
written explanation shall be given to the applicant.
The
drug regulatory authority under the State Council shall decide
within 90 working days if the product can be registered,
counting from the date of acceptance of the application. For
those not approved for registration, a written explanation
shall be given to the applicant.
Article
13 In
case any situation reflected in the content of the
registration certificate is changed, the holder of the
certificate shall apply for an amendment of the certificate
accordingly, or for re-registration within 30 working days
from the change.
Article
14 The
term of validity for the registration certificate of medical
devices is four years. The holder of the certificate shall
apply for re-registration within six months before the
certificate expires.
When
the manufacturing of a medical device is stopped continuously
for more than 2 years, its registration certificate is
automatically invalidated.
Article
15 Medical
devices manufactured shall meet the national standard, or
professional standards when there are no relevant national
standards available.
National
standards of medical devices shall be formulated jointly by
the standardization authority and the drug regulatory
authority under the State Council. Professional standards of
medical devices shall be formulated by the drug regulatory
authority under the State Council.
Article
16 The
instruction for use, label and package of medical devices
shall comply with relevant standards or provisions in China.
Article
17 The
registration number of a medical device shall be marked on the
product itself and the external package according to the
provisions of the drug regulatory authority under the State
Council.
Article
18 The
State implements a system of re-evaluation and obsolescence
for medical devices, the details of which shall be formulated
by drug regulatory authority under the State Council after
consulting with other related authorities under the State
Council.
Chapter
3 Administration of Production, Distribution and Use
of
Medical Devices
Article
19 Enterprises
manufacturing medical devices shall meet the following
conditions:
1.
Possess professional technical personnel required for the
manufacture of its medical devices;
2.
Possess facility and environment required for the manufacture
of its medical devices;
3.
Possess equipment required for the manufacture of its medical
devices;
4.
Possess an establishment or personnel and equipment for
quality testing required for the manufacture of its medical
devices.
Article
20 Establishment
of manufacturing of class I medical devices, requires that the
enterprise file a record with the drug regulatory authority of
provinces, autonomous regions or municipalities directly under
the central government.
Establishing
manufacturing of class II and/or class III medical devices,
requires inspection and approval by the drug regulatory
authorities of the provinces, autonomous regions and
municipalities directly under the central government, who will
then issue a Medical Device Manufacturing Enterprise License.
The industrial and commercial authority shall not issue a
business license to enterprises which have not received a
Medical Device Manufacturing Enterprise License.
The
term of validity of the Medical Device Manufacturing
Enterprise License is 5 years. Upon expiration, re-inspection
and license renewal shall be conducted. Implementation details
shall be formulated by the drug regulatory authority under the
State Council.
Article
21 Medical
device manufacturing enterprises shall not start manufacturing
products before obtaining the manufacturing enterprise
license.
Article
22 The
State implements a mandatory safety certification system for
certain class III medical devices. A specific product list
shall be established by the drug regulatory authority under
the State Council, jointly with the quality and technology
supervision authority.
Article
23 Enterprises
distributing medical devices shall meet the following
conditions:
1.
Possess appropriate facility(s) and environment for the kind
of medical devices to be distributed;
2.
Possess appropriate quality inspection personnel for the kind
of medical devices to be distributed;
3.
Possess adequate ability for technical training, maintenance
and after-sales services for the kinds of medical devices to
be distributed;
Article
24 Establishing
of distribution of class II and/or class III medical devices,
requires that the enterprise file a record with the drug
regulatory authority of provinces, autonomous regions or
municipalities directly under the central government.
Establishing
an enterprise distributing class II and/or class III medical
devices, requires inspection and approval by the drug
regulatory authorities of the provinces, autonomous regions
and municipalities directly under the central government, who
will then issue a Medical Device Distributing Enterprise
License. The industrial and commercial authority shall not
issue a business license to enterprises which have not
received a Medical Device Distributing Enterprise License.
The
term of validity of the Medical Device Distribution Enterprise
License is 5 years. Upon expiration, re-inspection and license
renewal shall be conducted. Implementation details shall be
formulated by the drug regulatory authority under the State
Council.
Article
25 The
drug regulatory authority of governments of provinces,
autonomous regions and municipalities directly under central
government shall decide within 30 working days whether the
licenses for manufacturing or distributing enterprises of
medical devices can be issued, counting from the date of
acceptance of the application. When a license is not issued, a
written explanation shall be given to the applicant.
Article
26 Distribution
enterprises and medical institutions shall purchase qualified
medical devices from enterprises having a Medical Device
Manufacturing Enterprise License or Medical Device
Distribution Enterprise License, and shall verify the
certificates of qualified products.
Distribution
enterprises shall not distribute medical devices without
registration certificates or certificates for qualified
products, or medical devices which are beyond their expiry
dates, of compromised effectiveness, or obsolete.
Medical
institutions shall not use medical devices without
registration, or certificate for qualified products, or
medical devices which are beyond their expiry dates, of
compromised effectiveness, or obsolete.
Article
27 Medical
institutions shall not re-use medical devices labeled for
single use, shall destroy them after use and establish a
record, according to relevant provisions of the country.
Article
28 The
State shall establish a quality incident reporting system and
a warning system of medical devices. Implementation details
shall be stipulated by the drug regulatory authority under the
State Council, in conjunction with the health authority and
family planning authority under the State Council.
Chapter
IV Supervision of Medical Devices
Article
29 The
drug regulatory authorities of governments at county level and
above shall appoint medical device monitors within their
organization, who are responsible for the supervision and
inspection of medical device manufacturing enterprises,
distribution enterprises and medical institutions within their
own administrative regions. When necessary, monitors may take
product samples and ask for relevant materials according to
the provisions promulgated by the drug regulatory authority
under the State Council. Institutions and individuals
concerned shall not decline cooperation or be deceitful in the
monitoring process. The monitors shall be responsible to keep
collected samples and materials confidential.
Article
30 The
State implements an accreditation system for the qualification
of the testing institutions of medical devices. Only testing
institutions accredited by the drug regulatory authority in
conjunction with the quality and technical supervision
authority under the State Council may conduct medical device
test.
Medical
device testing institutions and their staff members shall keep
strictly confidential all technical information provided by
enterprises whose products are being tested, and shall not
conduct or be involved in research and development,
manufacture, distribution and technical consultation related
to the devices tested.
Article
31 For
products having caused or which may potentially cause quality
incidents, the drug regulatory authority of the governments at
county level and above shall have the right to check, seal up
and detain them together with materials related.
Article
32 The
drug regulatory authority of the governments at provincial
level and above shall revoke the registration certificates of
medical devices of which safety and effectiveness can not be
ensured. Medical devices whose registration certificates have
been revoked shall not be manufactured, distributed and used.
Those already produced or imported shall be dealt with by the
drug regulatory authority of government at county level and
above.
Article
33 The
drug regulatory authorities of the government of the
municipality consisting of districts and above, which perform
product registrations in violation of these regulations, shall
be ordered by the drug regulatory authority under the state
council to correct the violations within a defined period. For
those not corrected within the period, the product
registration certificates may be revoked and the events may be
made public.
Article
34 Advertisements
of medical devices shall be reviewed and approved by the drug
regulatory authority of governments at provincial level and
above, and shall not be published, broadcasted, circulated or
posted before the approval.
The
contents of the advertisements shall be based on the
instruction for use approved by the drug regulatory authority
under the State Council or the drug regulatory authority of
the governments of provinces, autonomous regions and
municipalities directly under the Central Government.
Chapter
V Penalties
Article
35 In
cases of manufacturing medical devices without product
registration certificates, in violation of provisions of these
Regulations, the drug regulatory authority of governments at
county level and above shall issue an order to stop the
production, confiscate all of the illegally manufactured
products and related illegal income. Additionally, in case the
illegal incomes exceed RMB10 thousand yuan, a fine of 3 to 5
times the total sum of the illegal income shall be imposed; in
case there are no illegal incomes or the illegal incomes do
not exceed RMB10 thousand yuan, a fine of RMB10 thousand yuan
to RMB30 thousand yuan shall be imposed; in serious cases, the
drug regulatory authorities of the governments at the
provinces, autonomous regions and municipalities directly
under the Central Government shall revoke the Medical Device
Manufacturing Enterprise License; and in case crimes are
committed, criminal liability shall be investigated and
handled according to the law.
Article
36
In cases of manufacturing class II and class III medical
devices without a Medical Device Manufacturing Enterprise
License, in violation of these regulations, the drug
regulatory authority of governments at county level and above
shall issue an order to stop the production, confiscate all of
the illegally manufactured products and their illegal incomes.
Additionally, in case the illegal incomes exceed RMB10
thousand yuan, a fine of 3 to 5 times of the total sum of the
illegal incomes shall be imposed; in case there are no illegal
incomes or the illegal incomes do not exceed RMB10 thousand
yuan, a fine of RMB10 thousand yuan to RMB30 thousand yuan
shall be imposed; and in case crimes are committed, criminal
liability shall be investigated and handled according to the
law.
Article
37 In
cases of manufacturing medical devices not in conformity with
national standards or professional standards for medical
devices, in violation of provisions of these Regulations, the
drug regulatory authority of governments at county level and
above shall issue an warning, followed with an order to stop
the production, confiscate all of the illegally manufactured
products and their illegal incomes. Additionally, in case the
illegal incomes exceed RMB 5 thousand yuan, a fine of 2 to 5
times of the total sum of the illegal incomes shall be
imposed; in case there are no illegal incomes or the illegal
incomes do not exceed RMB 5 thousand yuan, a fine of RMB 5
thousand to 20 thousand yuan shall be imposed; in serious
cases, the product registration certificates shall be revoked
by the authorities originally issued the certificates; and in
case crimes are committed, criminal liability shall be
investigated and handled according to the law.
Article
38 In
cases of Distribution of class II and class III medical
devices without a Medical Device Distributing Enterprise
License, which violates provisions of these Regulations, the
drug regulatory authority of governments at county level and
above shall issue an order to stop the production, confiscate
all of the illegally manufactured products and their illegal
incomes. Additionally, in case the illegal incomes exceed RMB
5 thousand yuan, a fine of 2 to 5 times of the total sum of
the illegal incomes shall be imposed; in case there are no
illegal incomes or the illegal incomes do not exceed RMB 5
thousand yuan, a fine of RMB 5 thousand yuan to RMB 20
thousand yuan shall be imposed; and in case crimes are
committed, criminal liability shall be investigated and
handled according to the law.
Article
39 In
cases of distributing medical devices without registration
certificates or certificate for qualified products, or medical
devices which are beyond their expiry dates, of compromised
effectiveness, or obsolete, or purchasing medical devices from
enterprises without Medical Device Manufacturing Enterprise
License or Medical Device Distributing Enterprise License,
which violates provisions of these Regulations, the drug
regulatory authority of governments at county level and above
shall issue an order to stop the distribution, confiscate all
of the illegally distributed products and their illegal
incomes. Additionally, in case the illegal incomes exceed RMB
5 thousand yuan, a fine of 2 to 5 times of the total sum of
the illegal incomes shall be imposed; in case there are no
illegal incomes or the illegal incomes do not exceed RMB 5
thousand yuan, a fine of RMB 5 thousand to 20 thousand yuan
shall be imposed; in serious cases, the Medical Device
Distributing Enterprise License shall be revoked by the
authorities which originally issued the license; and in case
crimes are committed, criminal liability shall be investigated
and handled according to the law.
Article
40 In
cases where false certificates, documents, materials, or
product samples are submitted in registration applications, or
obtaining medical device registration certificates are
obtained using other deceitful means, which violate provisions
of these Regulations, the product registration certificates
shall be revoked by the authorities which originally issued
the certificates, and within a period of two years, other
product registration applications of the violating enterprise
shall not be accepted. Additionally, a fine of RMB 10 thousand
to 30 thousand yuan shall be imposed; for enterprises already
started manufacturing, all of the illegally manufactured
products and their illegal incomes shall be confiscated; in
case the illegal incomes exceed RMB10 thousand yuan, a fine of
3 to 5 times of the total sum of the illegal incomes shall be
imposed; in case there are no illegal incomes or the illegal
incomes do not exceed RMB10 thousand yuan, a fine of RMB 10
thousand to 30 thousand yuan shall be imposed; and in case
crimes are committed, criminal liability shall be investigated
and handled according to the law.
Article
41 Violation
of Article 34 of these Regulations concerning provisions for
advertisement of medical devices shall be dealt with by the
industrial and commercial authority according to relevant laws
and regulations of the country.
Article
42 In
cases of Medical institutions using medical devices without
registration certificates or certificate for qualified
products, or medical devices which are beyond their expiry
dates, of compromised effectiveness, or obsolete, or
purchasing medical devices from enterprises without Medical
Device Manufacturing Enterprise License or Medical Device
Distributing Enterprise License, which violate provisions of
these Regulations, the drug regulatory authority of
governments at county level and above shall issue an order for
correction, launch a warning, and confiscate all of the
illegally used products and illegal incomes. Additionally, in
case the illegal incomes exceed RMB 5 thousand yuan, a fine of
2 to 5 times of the total sum of the illegal incomes shall be
imposed; in case there are no illegal incomes or the illegal
incomes do not exceed RMB 5 thousand yuan, a fine of RMB 5
thousand to 20 thousand yuan shall be imposed, and person(s)
in charge and other directly responsible personnel shall
receive disciplinary punishment; and in case crimes are
committed, criminal liability shall be investigated and
handled according to the law.
Article
43 In
cases of medical institutions re-using devices for single use,
or not destroying devices which should be destroyed, which
violates provisions of these Regulations, the drug regulatory
authority of governments at county level and above shall issue
an order for correction and launch a warning, and may impose a
fine of RMB 5 thousand to 30 thousand yuan; in serious cases,
the medical institutions may be applied with a fine of RMB 30
thousand to 50 thousand yuan, and person(s) in charge and
other directly responsible personnel be applied with
disciplinary punishment; and in case crimes are committed,
criminal liabilities shall be investigated and handled
according to the law.
Article
44 In
cases in which medical institutions undertake clinical trials
or clinical verifications of medical devices and provide false
reports, which violates provisions of these Regulations, the
drug regulatory authority of governments at provincial level
and above shall issue an order for correction and launch a
warning, and may impose a fine of RM B 10 thousand to 30
thousand yuan£»in
serious cases, the qualification for clinical trial or
clinical verification of medical devices shall be terminated,
person(s) in charge and other directly responsible personnel
shall receive disciplinary punishment; an d in case crimes are
committed, criminal liability shall be investigated and
handled according to the law.
Article
45 For
cases in which testing institutions and their personnel are
found to be conducting or involved in research and
development, manufacturing, distribution and technical
consultation of medical devices which are related to the
testing, or establishing false testing reports, which violates
provisions of these Regulations, the drug regulatory authority
of governments at provincial level and above shall issue an
order for correction and launch a warning, and may impose a
fine of RMB 10 thousand to 30 thousand yuan; in serious cases,
the qualification for testing shall be terminated by the drug
regulatory authority under the State Council, person(s) in
charge and other directly responsible personnel shall be
receive disciplinary punishment; and in case crimes are
committed, criminal liability shall be investigated and
handled according to law.
Article
46 In
cases where personnel engaged in supervision and
administration of medical devices abuse their power, pursue
personal benefits by deceiving, or neglecting their duties, in
violation of provisions of these Regulations, to the extent to
which crimes are committed, criminal liabilities shall be
investigated and handled according to the law. For those not
committing crimes, disciplinary punishment shall be applied
according to the relevant regulations.
Chapter
VI Supplementary Provisions
Article
47 Provisions
governing non-profitable contraceptive devices shall be
formulated separately by the drug regulatory authority in
conjunction with other relevant authorities under the State
Council.
Article
48 These
Regulations shall come into force from April 1, 2000.
BACK |
