文胸英文医疗器械监督管理条例-英文

2021年1月22日发(作者：瘦骨嶙峋)
Regulations

Regulations for the Supervision and Administration of
Medical Devices
Regulations for the Supervision and Administration of Medical Devices

Chapter I 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
Peoples Republic of China shall comply with the Regulation.
Article 3

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
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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 II The Administration of Medical Devices

Article 7
The State encourages the research and development of new medical devices.
medical devices
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.
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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,
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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
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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 III 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;
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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.
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