Provisions for Medical Device Registration
Content
Chapter I General Provisions .................................................................................... 2
Chapter II Basic Requirement ........................................................................................ 3
Chapter III Product Technical Requirement and Registration Testing .......................... 5
Chapter IV Clinical Evaluation ...................................................................................... 6
Chapter V Product Registration ..................................................................................... 8
Chapter VI Change Registration .................................................................................. 13
Chapter VII Registration Extension ............................................................................. 15
Chapter VIII Product Filing ......................................................................................... 15
Chapter IX supervision and Administration ................................................................ 16
Chapter X Legal Responsibilities ................................................................................ 18
Chapter XI Supplementary Provisions......................................................................... 19
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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 refer to the prescribed procedures conducted by the food
and drug regulatory authority upon an application submitted by the registration
applicant to decide whether the medical device to be marked can be sold based on a
comprehensive assessment of the research and results of its safety and effectiveness
Medical device filing refer to the food and drug regulatory authority files Class I
medical device filing materials submitted by the filing applicant for the future
reference.
Article 4
Approval for medical device registration and filing shall follow the principle of justice,
equity and publicity.
Article 5
Filing administration shall implement for Class I medical devices. Registration
administration shall implement for Class II and Class III medical devices.
Class I domestic medical device shall be filed by 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.
Class I imported medical devices shall be filed by CFDA.
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Class II and Class III imported medical devices shall be inspected by CFDA, and the
Registration Certificate for Medical Device will be granted after approval.
The medical devices from Taiwan, Hong Kong and Macau shall be registered or filed
refer to the imported medical devices.
Article 6
A medical device registration applicant (hereinafter referred to as the applicant)
launches the product to the market in its own name and being held ultimately legal
liability for the product.
A medical device filing applicant (hereinafter referred to as the filing applicant)
launches the product to the market in its own name and being held ultimately legal
liability for the product.
The person apply for registration (conducting filing) for medical device shall have the
corresponding professional knowledge and be familiar with laws, regulations,
normative documents and technical requirements on the administration of medical
device registration (filing).
Article 7
Food and drug supervision and administration authority should publish the
registration and filing information timely in accordance with law. Applicant can
inquire the registration and filing progress and approval result. The public can inquire
the approval result.
Article 8
China encourages research and development as well as innovation of medical devices,
contributes to promotion and application of new technology of medical devices and
boosts the development of medical device industry. Special approval procedures for
innovative medical devices shall be formulated by CFDA separately.
Chapter II Basic Requirement
Article 9
The applicant (filing applicant) shall establish quality management system according to the Good
Manufacturing Practice (GMP) for Medical Devices, form it to documents and records, and
implement it and keep effective operation.
Applicant of innovative medical devices which should undertake special approval procedure can
entrust other enterprises to manufacture product samples, and the entrusted enterprise should be
qualified to have the product range. Applicant of innovative medical devices which shouldn’t
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undertake special approval procedure cannot entrust other enterprises to manufacture product
samples.
Article 10
Staff who manages the registration or filing should have the corresponding expertise, and be
familiar with corresponding registration laws, regulations, rules, and technical requirement.
Article 11
Applicant or filing applicant should ensure the medical devices are safe and effective, the research
and development process is normative and all the data are authentic, complete and traceable.
Article 12
Documents for applying registration or filing should be in Chinese. If the original copy of
documents is in foreign language, the Chinese version and the original version should both be
provided. When the unpublished documents are quoted, the permit to quote issued by document
owners should be also provided.
Applicant or filing applicant is liable for the authenticity of documents.
Article 13
To apply registration (or conduct filing) for imported medical device, the applicant
(filing applicant) shall get market permit for medical device in their home country or
region where their company is registered or the country or region where the
manufacturing site is located.
If home country or region of the applicant (filing applicant) do not administer the
products as medical device, the applicant (filing applicant) shall provide relevant
supporting documents, including market permit for legal sales in their home country
or region.
Article 14
The overseas applicant (filing applicant) shall entrust its representative office located
within the territory of China or designate an enterprise located within the territory of
China as its agent to conduct CFDA registration or filing for imported medical
devices.
The agent of the oversea applicant (filing applicant) that located within the territory of
China for shall be liable for:
(1)
Contact with corresponding food and drug regulatory authority and overseas
applicant (or filing applicant);
(2)
Deliver related laws, regulations and technical requirements to the applicant
(or filing applicant) truly and faithfully;
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(3)
Collect post-market adverse event information of medical devices and feed
back to overseas applicant (or filing applicant) , meanwhile, report to relevant
food and drug regulatory authority;
(4)
Coordinate the recall of 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
Applicant or filing applicant should draft the technical document of products to be
marketed. Filing applicant of class I product should submit the product technical
document to corresponding food and drug regulatory authority. Applicant of class II
and III product should submit the product technical document.
Technical document includes function index and test method. Function index includes
measurable function index and safety index and other index related to quality control.
Medical devices to be marketed in China should comply with technical requirements
for filing or registration.
Article 16
To apply registration for Class II and Class III medical device, the registration testing
shall be conducted. Medical device testing institute should conduct testing according
to product technical requirement.
The tested samples should comply with the requirement of medical device quality
management system. Only the products tested to be qulified can be used for clinical
trial or registration application.
To apply filing for Class I medical device, filing applicant should submit self-test
report.
Article 17
For the registration testing, the applicant shall provide registration testing institute
related technical materials, samples for registration testing, and product technical
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requirement required by the registration testing.
Article 18
Medical device testing institutes shall have certain qualifications, perform testing
within their specified testing scope and pre-evaluate the testing items. The testing
institutes shall grant the pre-evaluation opinions and the registration testing report of
medical device together to the registration 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 registration unit shall be the typical product that can
represent the safety and effectiveness of the other products in this registration unit.
Chapter IV Clinical Evaluation
Article 20
Clinical evaluation of medical device refers to the process that the applicant (filing
applicant) validates whether the medical devices satisfy the operation requirement or
indications by conducting clinical trial and/or getting clinical practice data or
literature.
Article 21
Clinical evaluation materials refer to the documents formed by the applicant (filing
applicant) through clinical evaluation.
For those required clinical trial, the clinical evaluation materials to be submitted shall
include clinical trial method and clinical trial report.
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:
(I) With definite operating principle, established design, mature manufacture process,
have no record for serious adverse event of substantially equivalent medical devices
which have been marketed and clinically applied for years; and without changing the
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conventional purpose of use;
(II) The safety and effectiveness of the medical devices can be proven through
non-clinical evaluation;
(III) The safety and effectiveness of the medical devices can be demonstrated
through the analysis and evaluation on the data obtained from clinical trials or clinical
application of the substantially equivalent medical devices.
The catalogue of the medical devices exempted from clinical trial shall be formulated,
adjusted and published by CFDA. Medical devices that are not included in the
exemption list can demonstrate the safety and effectiveness by analyzing the clinical
data obtained from substantially equivalent medical devices or clinical application
data. Applicant can specify the aforementioned statement and submit supporting
documents.
Article 23
The clinical trial of the medical device shall be conducted in a qualified clinical trial
institutes according to the requirements of the Good Clinical Practice (GCP) for
medical devices and medical device sample to be clinical tested should comply with
Good Clinical Practice requirements.
Article 24
The clinical trial of Class III medical devices with higher risk to human body shall be
approved by CFDA before execution. The clinical trial pre-approval catalogue of
Class III medical devices shall be formulated, adjusted, and published by CFDA.
Article 25
Clinical trial approval refers to the comprehensive analysis conducted by CFDA on
the risk level, clinical trial method, contrastive analysis report of clinical benefit and
risk and to determine whether approves executing clinical trial.
Article 26
For clinical trial executing needs to be approved, applicant needs to submit the
required documents to CFDA.
Article 27
When the application for clinical trial approval is accepted, CFDA should transfer the
application document to technical evaluation department within three workdays since
the day the application is accepted.
The medical device evaluation should be finished within 40 workdays by technical
evaluation department. CFDA should make the decision within 20 workdays since the
day the medical device evaluation is finished. If the clinical trial application is
approved, the approval letter shall be granted by CFDA; if not, reasons should be
stated in written document.
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Article 28
If supplementary documents are needed by technical evaluation department, applicant
should be informed of all the supplementary documents in one time and provide all of
the required supplementary documents within one year. Technical evaluation
department should finish the evaluation within 40 workdays since they receive the
supplementary documents. The time for preparing the supplementary documents is
not included in the evaluation time.
If the supplementary documents are not submitted by applicant within the required
time, technical evaluation department will terminate the evaluation and suggest to
disapprove and CFDA will make the decision of disapproval after examination.
Article 29
In one of the following situation, CFDA will withdraw the approval:
(1)
(2)
The application document for clinical trial is false.
New research validates the previous clinical trial which has been approved
by CFDA is of ethical and scientific problem.
(3)
Other circumstances that approval should be withdraw.
Article 30
Clinical trial shall be executed within three years after approval. Approval document
will be terminated automatically if the clinical trial is not executed within required
time. Applicant shall reapply if the clinical trial is still needed.
Chapter V Product Registration
Article 31
To apply for medical device registration, the applicant shall submit and deliver
application documents to the related food and drug regulatory authority
Article 32
The food and drug regulatory authority conduct administrative review 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, or the applicant has submitted all the
content correction according to the requirements.
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（2）
Reject the application and notify the applicant immediately if the application
is not within their functions；
（3）
Allow the applicant to correct the application documents on site if possible;
（4）
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;
The food and drug regulatory authority shall grant the dated acceptance notice 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 technical evaluation department within 3 workdays
from the date of document acceptance.
The technical review department of the food and drug regulatory authority shall
complete the technical review within 60 workdays for Class II medical device and
complete the technical review within 90 workdays for Class III medical device.
During the review process, the technical review department shall notify the applicant
in writing when they need to consult experts or hold a hearing, or hold joint
technical review with drug reviewer for drug-device combination products. The time
for consulting experts or holding a hearing shall not be calculated in the overall
review timeline.
Article 34
The technical review department of the food and drug regulatory authority shall
conduct technical review for application documents submitted and retrieve original
research materials when necessary. The food and drug regulatory authority shall carry
out inspection on quality management system based on the GMP for medical devices,
focus on inspecting applicant’s design control procedure and manufacturing.
The food and drug regulatory authority of the province (autonomous region, and
municipality directly under the central government) shall conduct inspection on
quality management system for domestic medical devices of class I and class II. The
inspection on quality management system of domestic medical device of class III
shall be conducted by the food and drug regulatory authority of the province
(autonomous region, and municipality directly under the central government) which
are infomed by CFDA when it deems necessary. The inspection on quality
management system shall be completed within 30 workdays.
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CFDA shall organize inspection on quality management system if they deem it is
necessary during technical evaluation for imported medical devices of class II and
class III. CFDA shall inform of quality management system inspection department to
conduct inspection on quality managemtn system of applicant. Technical department
shall participate in inspection when necessary.
The inspection time shall not be calculated in the overall evaluation timeline.
Article 35
If supplementary documents are required during the technical review, the applicant
shall be informed once of all the supplements and amendments to be made by the
technical review department. The applicant shall submit all necessary supplement or
correction materials once within one year from the date of receiving the notice
according to the requirements of the technical review department; the technical
review department shall complete the technical review within 60 workdays from the
date of receiving the materials supplemented or corrected. Time required by applicant
for supplementing and correcting such materials shall not be calculated in the overall
review timeline.
The technical review department shall come up with review termination suggestion to
the food and drug regulatory authority once the applicant fail to supplement or correct
the materials within the specified timeframe, and the decision for returning
application and terminating review shall be made by the food and drug regulatory
authority.
Applicant holding opposition about the supplement or correction can file a written
suggestion stating reasons and providing supporting technical documents.
Article 36
The Food and drug regulatory authority accepting the registration application shall
make decisions within twenty workdays after technical review. When requirements
concerning safety and effectiveness are met, and registration shall be approved and
the Registration Certificate for Medical Device shall be granted within ten workdays
since the date on which approval decision has been made; For those registration are
not approved, the authorities shall state the reasons in written and inform the applicant
that they have right to re-evealuate or apply for administrative reconsideration or
bring up to administrative litigation in accordance with laws and regulations.
The validity term of the Registration Certificate for Medical Device is five years.
Article 37
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Medical device registration includes approval matters and administrative matters.
Approval matters include product name, product model, product standard, product
structure and composition, indications, technical requirement as well as
manufacturing address of imported medical devices. Administrative matters include
applicant name and registered address, agent name and registered address,
manufacturing address of domestic medical devices.
Article 38
For medical device required for the treatment of rare disease and dealing with
unexpected public health events, the food and drug regulatory authority shall require
applicant to further complete relevant work, recorded in the Registration Certificate
for Medical Device after the product launch.
Article 39
If the accepted registration application has one of the following circumstances, the
food and drug regulatory authority shall decide to reject the application and notify the
applicant:
（1） The research and its result conducted by the applicant cannot approve the
safety and effectiveness of medical device to be sold;
（2） The registration application documents have forged or false contents;
（3） The registration application documents have confused or inconsistent contents;
（4） The registration application documents have clearly inconsistent contents with
those of application items;
（5） The form of registration cannot meet the requirements after the technical
review; or
（6） Other circumstances that the registration application shall be refused.
Article 40
For the accepted registration application, the applicant may, prior to the administrative
decision is made, withdraw the registration application and give reason to the food
and drug regulatory authority who accept the application.
Article 41
For the accepted registration application, if there are evidences providing that the
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registration application documents have forged or false contents, the food and drug
regulatory authority shall suspend the review. After verification, the food and drug
regulatory authority shall determine to continue review or to reject the registration
application in accordance with the verification conclusion.
Article 42
If the applicant has any objection to the decision of disapproval by the food and drug
regulatory authority, the applicant may put forth re-evaluation application to the food
and drug regulatory authority that makes the decision within 20 workdays after the
receipt of the notice of disapproval for registration application.
The contents applied for re-evaluation shall be limited to original application and
original application documents.
Article 43
The food and drug regulatory authority shall make the re-evaluation decision within
30 workdays after accepting the application for re-evaluation and inform the applicant
of the conclusion. In case the original judgment is affirmed, the food and drug
regulatory authority will not accept the secondary application for re-evaluation by the
applicant.
Article 44
If the applicant has any objection to the decision of disapproval by the food and drug
regulatory authority and has applied for administrative reconsideration or
administrative litigation, the food and drug regulatory authority will not accept the
re-evaluation application raised by the applicant.
Article 45
In case of lost of the Registration Certificate for Medical Device, the applicant of
medical device shall publish lost declaration at the media specified by original
certificate-issuing authority, and apply to original certificate-issuing authority for
re-issuing such certificate after 1 month of declaration. Original certificate-issuing
authority shall re-grant the Registration Certificate for Medical Device within 20
workdays.
Article 46
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When major interest relationship between the applicant and others is directly involved
in the application for medical device registration, the food and drug regulatory
authority shall inform the applicant and interest party of right to apply for hearing in
accordance with laws, regulations and other provisions of CFDA; during the process
of reviewing the application for medical device registration, the food and drug
regulatory authority shall publicize major approval matters that are deemed to have
been involved in public interests and hold a hearing.
Article 47
Newly developed and researched medical devices which have not been classified into
any classes, can apply for registration as class III directly, or determine its
classification according to its classsifying principle and submit to CFDA for
confirmation. When the classfication is confirmed by CFDA, registration or filing can
be started.
CFDA determines the classification based on risk level of medical devices. Domestic
medical devices being determined into class II, CFDA shall transfer corresponding
documents to the food and drug authority of provinces, automonous region,
municipality directly under the control of central government for review and approval.
Domestic medical devices being classified into class I, CFDA shall transfer
corresponding documents to the food and drug authority of municipal level for filing.
Article 48
Disputes regarding patent right occurred during the registration application and
evaluation process or after the registration approval shall be settled in accordance with
relevant laws and regulations.
Chapter VI Change Registration
Article 49
For registered Class II or Class III medical device, to change the content in their
Registration Certificate for Medical Device and its appendixes, the applicant shall
apply to the original registration authority for change registration and submit the
application materials.
For changing product name, model, standard, structure, composition, indications,
product technical requirement, manufacturing address of imported medical devices,
the applicant shall apply to original registration department for Change of Approval
Matters
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For changing the name or registered address of the applicant, manufacturing address
(literal change), or name and registered address of the agent, the applicant shall apply
to original registration department for Change of Administrative Matters; for changing
the registered address of domestic medical devices, applicant shall apply to original
registration department for Change of Approval Matters then apply for Change of
Administrative Matters.
Article 50
The food and drug regulatory authority shall approve Change of Administrative
Matters when it meet the requirements, and grant the Permission of change to the
Registration of Medical Device with 10 workdays. The food and drug regulatory
authorities shall inform the applicants all the materials needed to be supplemented and
corrected when the materials for Change of Administrative Matters are not complete
or not meet the requirements through the administrative review.
Article 51
For the Change of Approval Matters, technical review department shall focus on
reviewing the changed parts and evaluate the product safety and effectiveness after
the change.
The food and drug regulatory authority accepting the application for Change of
Approval Matters shall organize technical review within the period specified in
Chapter VI of the Provision
Article 52
The Permission of Change to the Registration of Medical Device shall be used in
conjunction with the original Registration Certificate for Medical Device and its
validity period shall be the same with that of the original registration certificate. The
applicants shall revise IFU by themselves according to the approved content of the
permission of change.
Article 53
Where provisions concerning acceptance and approval procedures of the Change of
Approval Matters application are not available in this chapter, Chapter VI of the
Provision shall prevail.
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Chapter VII Registration Extension
Article 54
Where it is required to extent validity period of the Registration Certificate for
Medical Device granted by food and drug regulatory authority, the applicant shall
apply extension to corresponding food and drug regulatory authority based on the
classification of products, six months prior to the expiration date and submit
application documents according to corresponding requirements.
The food and drug authority receiving application for extension shall make the
decision for extension prior to the validity date of original registration certificate.
Where the decision has not made before the deadline, it is deemed the application for
extension is approved. The circumstances in Article 55 are excluded.
Article 55
The registration extension shall not be granted in any of the following circumstances:
(I) The applicant fails to submit the application for registration extension within the
specified period;
(II) Mandatory standards of medical device have been revised, and the medical
device fails to meet requirement of the new standards;
(III) For medical device required for the treatment of rare disease and dealing with
unexpected public health emergencies, the applicant failed to complete matters stated
in Registration Certificate for Medical Device in a specified time when registration
department approving such registration and put forward this requirement.
Article 56
Where provisions concerning acceptance and approval procedures of application for
registration extension of medical device are not outlined in this Chapter, Chapter V
hereof shall prevail.
Chapter VIII Product Filing
Article 57
Filing applicant should apply for filing to corresponding food and drug regulatory
authority before manufacturing medical device of class I.
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Article 58
For Class I medical device filing, the applicant shall submit the filing materials in
accordance with corresponding requirements in the Article IX of Medical Device
Supervision and Management Provision.
The food and drug regulatory authority shall file a record on-site when the filing
material meets the requirements. The applicant shall be informed of all the
supplements and amendments to be made once and for all when the filing material are
not complete or cannot meet the filing requirements.
The food and drug regulatory authority shall make the filing certificate according to
the format and grant to the filing applicant, and publish the information from the
Filing Information Form for Class I Medical Device on their website.
Article 59
For filed Class I medical device, when the contents set forth in the Filing Information
Form for Class I Medical Device changed, the filing applicant shall submit a
description of the changes and related supporting documents to the original filing
department apply for change of filing. Where filing materials meet the formal
requirements, the food and drug regulatory authority shall file a record and update
corresponding filing information and publicized on its website.
Article 60
In case that classification management of filed Class I medical device is adjusted to be
Class II or Class III medical device, the filing applicant shall apply to corresponding
food and drug regulatory authority initiatively for the cancellation of original filing
information and apply for registration according to the Provisions.
Chapter IX supervision and Administration
Article 61
CFDA shall be responsible for supervision and administration of registration (filing)
of medical device in China, organize supervision and inspection, and timely inform
the inspected situation.
Article 62
The provincial, autonomous region and municipality directly under the central
government food and drug regulatory authorities shall be responsible for supervision
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and administration of registration (filing) of medical device within their
administration area, and define the regulatory responsibilities of provincial, municipal
or county food and drug regulatory authority organize supervision and inspection and
report relevant conditions to CFDA.
Article 63
The provincial, autonomous region and municipality directly under the central
government food and drug regulatory authorities shall conduct supervision and
management of registration (filing) for imported medical devices in their
administration territory.
Article 64
The food and drug regulatory authorities of the municipality consisting of districts
shall perform the self-inspection of their filing work regularly and submit related
information to provincial food and drug regulatory authorities timely.
Article 65
Where registration certificate for registered medical devices should be canceled
according to laws and regulations or applicant does not apply for extension prior to
the validity date of registration certificate, the food and drug authority will cancel the
original registration certificate and publicize it.
Article 66
Where classification management of registered medical device is adjusted from higher
class to lower class, the Registration Certificate for Medical Device within the period
of validity shall continue to be effective. The applicant shall apply for registration
extension or filing based on changed classification to corresponding food and drug
regulatory authority six months prior to the expiration of validity period of the
registration certificate.
Where classification management of registered medical device is adjusted from lower
class to higher class, the applicant shall follow the Provisions in Chapter VI and apply
for registration to the food and drug regulatory authority according to the
requirements on the changed classification. CFDA shall make provisions on
validation period of the original Registration Certificate for Medical Device when
publish the notice for classification adjustment.
Article 67
In case that the food and drug regulatory authorities of province, autonomous region
and the municipality consisting of districts conduct medical device filing by
violating the Provisions, CFDA shall order them to make corrections with a deadline;
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in case they fail to make corrections before the deadline, CFDA can cancel those
Registration Certificates for Medical device.
Article 68
The food and drug regulatory authorities, relevant technical institutions and their
employees shall keep confidential for all the testing data and technical secrets
submitted by the applicant (filing applicant).
Chapter X Legal Responsibilities
Article 69
In case that the Registration Certificate for Medical Device, are obtained by providing
spurious materials or by other deception means, the license or permit already obtained
shall be revoked by original issuing authority and punishment shall be made
according to the Article 64 of the Regulations for the Supervision and Administration
of Medical Devices.
In case that the filing for Medical Device, are obtained by providing spurious
materials or by other deception means, the license or permit already obtained shall be
revoked by original issuing authority and punishment shall be made according to the
Article 64 of the Regulations for the Supervision and Administration of Medical
Devices.
Article 70
In case of falsifying, altering, buying or selling, leasing, and lending relevant the
Registration Certificate for Medical Device, the certificate shall be taken back or
revoked by the original issuing authority and punishment shall be made according to
the Article 64 of the Regulations for the Supervision and Administration of Medical
Devices.
Article 71
For those violate the Provisions and sell and use the Class II or Class III medical
device failed to register Change of Administrative Matters according to this
provisions, the food and drug regulatory authority at county level and above shall
make punishment according to the Provisions related to those failing to get the
Registration Certificate for Medical Device of the Regulations for the Supervision
and Administration of Medical Devices.
Article 72
For those violate the Provisions and sell and use the Class II or Class III medical
device failed to register Change of Approval Matters according to this provisions, the
food and drug regulatory authority at county level and above shall make punishment
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according to the Provisions related to those failing to get the Registration Certificate
for Medical Device of the Regulations for the Supervision and Administration of
Medical Devices.
Article 73
For those fail to conduct clinical trial according to this provisions and Supervision and
Administration of Medical Device, the food and drug regulatory authority at county
level and above shall order them to make corrections with a deadline and punish them
with maximum 30,000 Yuan penalty. In serious circumstance, the clinical trial should
be terminated and the approval for clinical trial should also be cancelled.
Chapter XI Supplementary Provisions
Article 74
Registration (filing) unit is divided based on technical principle, structure,
performance index, and indications.
Article 75
The specified composable parts on Structure and Composition on registration
certificate shall be used for changing consumbles, after-service and maintenance. The
one used for applying for registration certificate can be sold solely.
Article 76
The form of Registration Certificate for Medical Device shall be formulated by
CFDA.
The registration numbers shall be arranged in the following form:
×1 XZ ×2××××3 ×4 ××5 ××××6. Among which:
×1 shall be the abbreviation of the place where the registration authority is located:
The letter “G” shall be adopted for domestic Class III medical device, imported Class
II medical device, or imported Class III medical device;
The abbreviation of the province, autonomous region or municipality where the
registration authority is located shall be adopted for Class II medical devices;
×2 shall indicate the form of registration:
“N” is applicable to domestic medical devices;
“I” is applicable to imported medical devices;
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“X” is applicable to medical devices from Taiwan, Hong Kong and Macao;
××××3 shall indicate the year of initial registration;
×4 shall indicate the classification;
××5 shall indicate the product classification code;
××××6 shall indicate the serial number of initial registration.
For the registration extension, ××××3 and ××××6 shall remain the same. In case of the
change of classification, a new registration number shall be granted.
Article 77
The registration numbers of Class I medical device shall be arranged in the following
form:
×1 XB××××2 ××××3, among which:
×1 shall be the abbreviation of the place where the filing authority is located:
The letter “G” shall be adopted for imported Class I medical device;
The abbreviation of province, autonomous region or municipality directly under the
central government combines the abbreviation of municipality consisting of districts
where filing authority is located (if there is no corresponding municipality consisting
of districts, use the abbreviation of province, autonomous region or municipality
directly under the central government only) shall be adopted for domestic Class I
medical device;
××××2 shall indicate the year of filing;
××××3 shall indicate the serial number of initial filing.
Article 78
Registration (filing) administration requirements of in vitro diagnostic administered as
medical device is applicable to Provision for In vitro Diagnostic Registration.
Article 79
Emergent approval procedure for medical devices and special approval procedure for
innovative medical devices shall be formulated by CFDA additionally.
Article 80
When necessary, CFDA can entrust food and drug authority of provinces, autonomous
region and municipality directly under control of central government or technical
institute, and corresponding social institute to do some work of dealing with
registration.
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Article 81
Charges item and charging standard for medical device registration comply with the
regulation of finance department of State Council and Price Administration
Department
Article 82
The Provisions shall come into force by Oct. 1, 2014. The Provisions for Medical
Device Registration promulgated by SFDA on August 9, 2004 shall be abolished at
the same time.
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