回击医疗器械注册管理办法英文(四号令)

2021年1月22日发(作者：tremendous)
Provisions for Medical Device Registration

Chapter I

General Provisions

Article 1

The Provisions are formulated in accordance with the Regulations for the Supervision
and Administration of Medical Devices with a view to standardizing the registration
and filing administration of medical device and guarantee the safety and
effectiveness of medical devices.

Article 2
All medical devices sold and used within the territory of the People's Republic of
China shall comply with the Provisions to apply for registration or conduct filing.

Article 3
Medical device registration refers to approval process conducted by the food and
drug regulatory authority upon an application submitted by the registration applicant,
follows the legal procedure to decide whether the medical device to be marked can
be approved or not based on a comprehensive assessment on research and its result
of medical device’s safety and effectiveness.

Medical device filing refers to the food and drug regulatory authority files filing
materials submitted by the filing applicant for future reference.

Article 4
Registration and filing shall follow the principle of publicity, justice, and equity.


Article 5

Filing administration shall be implemented for Class I medical devices. Registration
administration shall be implemented for Class II and Class III medical devices.
Filing for Class I domestic medical device, the filing applicant shall submit the filing to
the food and drug regulatory authority of the municipality consisting of districts.
Class II domestic medical devices shall be inspected by the food and drug regulatory
authority of the provinces, autonomous regions, municipalities directly under the
central government, and the Registration Certificate for Medical Device will be
granted after approval.
Class III domestic medical devices shall be inspected by the China Food and Drug
Administration (hereinafter referred to as CFDA), and the Registration Certificate for
Medical Device will be granted after approval.
Filing for Class I imported medical device, the filing applicant shall submit the filing to
CFDA.
Class II and Class III imported medical devices shall be inspected by the CFDA, and the
Registration Certificate for Medical Device will be granted after approval.
The medical devices from Hong Kong, Macau and Taiwan shall be registered or filed
refer to the imported medical devices.

Article 6
The registration applicant and filing applicant shall launch product to the market in
its own name and hold legal liability for the product.

Article 7
The food and drug regulatory authority shall publicize information of medical device
registration and filing according to the regulations. The applicant can inquiry the
approval process and results, the public can look up approval results.

Article 8
China encourages research and development and innovation of medical devices,
conducts special approval procedures for innovative medical devices, contributes to
promotion and application for new technology of medical devices and boosts the
development of medical device industry.


Chapter II

Basic Requirement

Article 9




The applicant or the filing applicant shall establish quality management system
related to R&D and manufacture of product, implement it and keep it operates
effectively.

For domestic products approved by the special approval procedures for innovative
medical device apply for the registration application and samples entrusted other
manufacturers to produce, the entrusted manufacturers shall have corresponding
manufacturing scope; for domestic products not approved by the special approval
procedures for innovative medical device apply for registration application, their
samples cannot entrust other manufacturers to produce.

Article 10

The person that apply for registration or conduct filing for medical device shall have
the corresponding professional knowledge and be familiar with laws, regulations,
normative documents and technical requirements regarding to medical device
registration or filing administration.

Article 11
The applicants or the filing applicants shall follow the basic requirement for safety
and effectiveness of medical device, ensure R&D process are being truthful and
standardized , and all the data is true, complete and traceable when they conduct
filing or apply for registration.


Article 12
The materials for registration application shall use Chinese.

When the application
documents are translated from a foreign language, the original documents shall also
be provided at the same time. When referring to unpublished literature, the
applicant shall provide evidence of owner’s permission to use the information.

The applicant shall take fully responsibility for the authenticity of the registration
application documents.

Article 13

For imported medical device intended to apply for registration or conduct filing, the
applicant or the filing applicant shall get market clearance of the country or region
where their registration or manufacturing place located for the medical device.
If country or region where the applicant
’
s or the filing applicant
’
s registration or
manufacturing places located does not administer the products as medical device,
the applicant or the filing applicant shall provide relevant supporting documents,
including the approval of legal sales issued by the country or region where their
registration or manufacturing place located.

Article 14





The overseas applicant or the filing applicant shall conduct relevant business through
their representative office located within the territory of China or designate an
enterprise located within the territory of China as agent.
Besides conduct registration and filing related work, the agent shall be liable for:

(1)
Contact with corresponding food and drug regulatory authority and the overseas
applicant or the filing applicant;

(2)
Deliver related laws, regulations and technical requirement to the applicant or
the filing applicant truly and faithfully;

(3)
Collect post-market adverse event information of medical devices and feed back
to the overseas applicant or the filing applicant , meanwhile, report to relevant food
and drug regulatory authority;

(4)
Collaborate the recall for post-market medical devices, and report to relevant
food and drug regulatory authority;
(5)
Undertake other joint liabilities related to product quality and after-sales service.


Chapter III

Product technical requirement and Registration Testing
Article 15

The applicant or the filing applicant shall prepare the product technical requirement
of the medical device to be registered or filed. The product technical requirement of
Class I medical device shall be submitted to the food and drug authorities during the
applicant conducts filing. The product technical requirement of Class II or Class III
medical devices shall be checked and approved by the food and drug authorities at
the time of registration approval.
The product technical requirement mainly includes the performance indices and
testing method of the completed medical device, and the performance indices refer
to the objective determination of product functionality, security index and other
indicators of quality control.
The medical device launched in China shall comply with its product technical
requirement which was checked and approved for registration or filed already.

Article 16
The registration testing shall be conducted to apply registration for Class II and Class
III medical device. The testing institutes of medical device shall conduct registration
testing according to product technical requirement.

The manufacture of samples for registration testing shall comply with related
requirements of quality management system; products tested to be qualified in
registration testing can be used for clinical trial or registration application.

The filing applicant can submit self-testing report of the product to conduct filing.

Article 17
To apply for registration testing, the applicant shall provide samples, product
technical requirement and other technical materials required by the registration
testing to the testing institutes.

Article 18
Testing institutes of medical device shall have certain qualifications, perform testing
within their specified testing scope and conduct pre-evaluation on the product
technical requirement. The testing institutes shall issue the pre-evaluation opinions
and the registration testing report of medical device together to the applicant.


For the medical devices that have not been included in testing scope of any medical
device testing institutes, the related registration authority shall designate a capable
testing institute to conduct the testing.

Article 19

The testing products in a same registration unit shall represent the safety and
effectiveness of the rest products in this registration unit.



Chapter IV


Clinical Evaluation

Article 20

Clinical evaluation of medical device refers to the process that the applicant or the
filing applicant validates whether a product can meet the operating requirements or
scope of application or not through clinical literature, clinical practice data, clinical
trial and other information.

Article 21
Clinical evaluation materials refer to the documents formed by the applicant or the
filing applicant during the clinical evaluation.
For those required clinical trial, the clinical evaluation materials to be submitted shall
include the protocol and the report of clinical trial.

Article 22
It is not necessary to conduct clinical trial for filing Class I medical devices. It is
necessary to conduct clinical trial for registration application of Class II and Class III
medical devices; however, in any of the following circumstances, the clinical trial
could be exempted.
(1) With definite operating principle, established design, mature manufacture
process; no record for serious adverse event of substantially equivalent medical
devices which have been marketed and clinically applied for years; and without
changing the conventional purpose of use;
(2)
The safety and effectiveness of the medical devices can be proven through
non-clinical evaluation;

(3)
The safety and effectiveness of the medical devices can be demonstrated
through analyzing and evaluating the data obtained from clinical trial or clinical
application of the substantially equivalent medical devices.

The clinical trial exemption list of medical device shall be formulated, adjusted and
published by the CFDA. For products that not listed in the clinical trial exemption list
of medical device and can prove themselves to be safe and effective through
analyzing and evaluating the data obtained from clinical trial or clinical application of
the substantially equivalent medical devices, the applicant can made an explanation
at the time of registration application and provide relevant supporting materials.

Article 23

The clinical trial of medical device shall be conducted in a qualified clinical trial
institutes according to the requirements of the Good Clinical Practice (GCP) for
medical devices. The manufacture of samples for clinical trial shall comply with the
quality management system of medical device.

Article 24

The clinical trial of Class III medical devices with higher risk to human body shall be
approved by CFDA before execution. The list for Class III medical devices which
required getting an approval for conducting clinical trial shall be formulated, adjusted,
and published by CFDA.

Article 25
The approval of clinical trial refer to the process that CFDA

decides whether the
clinical trial can be conducted by making comprehensive analysis on risk level, clinical
trial protocol, clinical benefits, risk analysis report and others of medical device to be
conducted clinical trial according to the applicant
’
s application.

Article26
For applicants need to process the approval of medical device clinical trial,
application materials shall be submitted to the CFDA by following the relevant
requirements.

Article 27

CFDA shall pass the application materials to the technical evaluation department for
medical device in 3 workdays after they accepted the application for the approval of
medical device clinical trial.
The technical evaluation department shall complete technical evaluation in 40
workdays and CFDA shall make decision in 20 days afterwards. For those approved to
conduct clinical trial, the Permission for Medical Device Clinical Trial shall be issued;
for those not approved to conduct clinical trial, the reason shall be stated in written.


Article 28
If supplementary documents are required during the technical evaluation, the
applicant shall be informed once of all the supplements and amendments to be
made. The applicant shall submit all necessary supplementary materials once within
1 year according to the notice of supplements and amendments. The technical
evaluation department shall complete the technical evaluation within 40 workdays
from the date of receiving the materials supplemented or amended. Time required
by the applicant for supplementing such materials shall not be calculated in the
overall evaluation timeline.
The technical evaluation department shall terminate evaluation and come up with
disapproval suggestion to the food and drug regulatory authority if the applicant fails
to submit the supplementary materials within the specified time, and the decision
for disapproval shall be made by the food and drug regulatory authority after
checked.

Article 29

Under any of the following circumstances, the food and drug regulatory authorities
shall revoke the acquired Permission for Medical Device Clinical Trial
：

(1) There is false content in clinical trial applications;

(2) The original approved clinical trial is verified by the latest research for ethical and
scientific problems;

(3) Other circumstances shall be revoked.

Article 30
The medical device clinical trial shall be implemented within 3 year after its approval.
For those overdue, the original approved document shall be invalidated automatically.
For those that are still need to conduct clinical trial, they shall re-submit the
application.

Chapter V



Product Registration

Article 31

To apply for medical device registration, the applicant shall submit and deliver
application documents to the food and drug regulatory authority based on relevant
requirements.

Article 32
The food and drug regulatory authority shall conduct administrative review on
application materials after they received applications for medical device registration,
and shall take actions respectively according to the following circumstances:
(1)

Accept registration applications when the application item is within their
function and the application materials are complete and comply with the
requirements of administrative review;
(2)

Allow the applicant to correct the application documents on site if possible;
(3)
Inform the applicants all the content correction to be made for once within five
workdays when found the application materials are incomplete or do not meet the
requirement of administrative review; if no information are given by 5 workdays, the
application shall be deemed as being accepted since the acceptance date of
application materials;
(4)
Reject the application and notify the applicant immediately if the application is
not within their functions
；

The food and drug regulatory authority shall grant the dated acceptance or
non-acceptance notice affixed with its special seal to indicate them accepting or
rejecting to accept the medical device registration application.

Article 33

The administrative department of the food and drug regulatory authority shall
forward the registration application to the technical evaluation department within 3
workdays from the date of document acceptance.

The technical evaluation department of the food and drug regulatory authority shall
complete the technical evaluation within 60 workdays for Class II medical device
registration and complete the technical evaluation within 90 workdays for Class III
medical device registration.
For those technical evaluations need to hire outside experts, hold joint technical
evaluation with drug evaluation department for drug-device combination products,
the extra time shall not be calculated in the overall review timeline, and the technical
evaluation department shall give a written notice to applicant for needed extra time.

Article 34
The food and drug regulatory authority can retrieve original research materials, and
organize inspection for quality management system regarding to product R&D and
manufacture during the technical evaluation.
The food and drug regulatory authority of the province, autonomous region, and
municipality directly under the central government shall conduct the inspection for
quality management system of Class II and Class III domestic medical device
registration; for Class III domestic medical device, CFDA shall inform the
corresponding food and drug regulatory authority of the province, autonomous
region, and municipality directly under the central government to conduct the
inspection, and get itself involved if necessary. The food and drug regulatory
authority of the province, autonomous region, and municipality directly under the
central government shall complete the inspection within 30 workdays according to
relevant requirement.
During the technical evaluation for Class II and Class III imported medical device
registration, the technical evaluation department of CFDA can inform technical
institute of quality management system of CFDA to conduct the inspection when
they deem it is necessary, and the technical evaluation department will also
participate in the inspection if necessary.

The inspection time for quality management system shall not be calculated in
technical evaluation time.



Article 35

If supplementary materials are required during the technical evaluation, the
applicant shall be informed once of all the supplementary contents to be made by
the technical evaluation department. The applicant shall submit supplementary
materials once within 1 year according to the requirements of supplement notice;
the technical evaluation department shall complete the technical evaluation within
60 workdays from the date of receiving the supplementary materials. Time required
by applicant for supplementing such materials shall not be calculated in overall
evaluation timeline.

If the applicant has any objection to the content of supplement notice, they can
propose written suggestion to the technical evaluation department, explain the
reason and provide corresponding technical supporting materials.
The technical evaluation department shall terminate evaluation and come up with
disapproval suggestion if the applicant failed to supplement materials within the
specified timeframe, and the disapproval decision shall be made by the food and
drug regulatory authority.

Article 36

The food and drug regulatory authority accepting the registration application shall
make decisions within 20 workdays after technical evaluation. Where requirements
concerning safety and effectiveness are met, registration shall be approved and the
Registration Certificate for Medical Device shall be granted within 10 workdays after
the date in which approval decision has been made, and the checked and approved
product technical requirement shall be provided to the applicant as attachment. For