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State Food and Drug Administration
Decree of the State Food and Drug Administration
No. 16
The “Measures for the Administration of Medical Device Registration”, which were deliberated and adopted at the working meeting of
the State Food and Drug Administration on May 28, 2004, are hereby promulgated, and shall come into force as of the date of promulgation.
Zheng Xiaoyu, Director General
August 9, 2004
Measures for the Administration of Medical Device Registration
Chapter I General Provisions
Article 1
These Measures are formulated in accordance with the “Regulations on the Supervision and Administration of Medical Devices” in order
to regulate the administration of medical device registration, and ensure the security and utility of medical devices.
Article 2
Whoever sells or uses medical devices inside the People’s Republic of China shall apply for registration in accordance with these
Measures, and no medical device shall be sold or used without being approved for registration.
Article 3
Medical device registration means the process of carrying out systematic appraisal pursuant to legal procedures on the security and
utility of the medical devices to be sold on the market and to be used, so as to decide whether or not to approve their sale and
use.
Article 4
The State administers medical devices by classified registration.
The medical devices on Category I inside China shall be examined by the (food) drug administration at the level of a city divided
into districts, and upon approval, a medical device registration certificate shall be issued to the party concerned.
The medical devices on Category II inside China shall be examined by the (food) drug administration of the province, autonomous region,
or municipality directly under the Central Government, and upon approval, a medical device registration certificate shall be issued
to the party concerned.
The medical devices on Category III inside China shall be examined by the State Food and Drug Administration, and upon approval, a
medical device registration certificate shall be issued to the party concerned.
The medical devices from abroad shall be examined by the State Food and Drug Administration, and upon approval, a medical device registration
certificate shall be issued to the party concerned.
The registration of medical devices from the regions of Taiwan, Hong Kong and Macao shall, unless otherwise prescribed by these Measures,
be handled with reference to that for medical devices from abroad.
The validity period for a medical device registration certificate is 4 years.
Article 5
The medical device registration certificate shall be uniformly printed and made by State Food and Drug Administration, with the corresponding
contents to be filled in by the (food) drug administration responsible for examination, approval and registration.
The registration number shall be laid out as follows:
1 (shi) yao jian xie () zi aaa No. aaaa. Among which,
shall be the shortened form of the locality of the registration and approval organ:
For the medical devices on Category III inside China, medical devices from abroad and those from the regions of Taiwan, Hong Kong
and Macao, such shortened form shall be indicated as the character of “Guo”, which means national;
For the medical devices on Category II inside China, such shortened form shall be indicated as that of the province, autonomous region,
or municipality directly under the Central Government where the registration and approval organ is located;
For the medical devices on Category I inside China, such shortened form shall be indicated as that of the province, autonomous region,
or municipality directly under the Central Government where the registration and approval organ is located, plus that of the administrative
area at the level of city divided into districts, namely, a (if there is no corresponding administrative area at the level of
city divided into districts, it shall only be the shortened form of the province, autonomous region, or municipality directly under
the Central Government);
shall be the registration form (whether approved [zhun], imported [jin] or permitted [xu]):
The form of being “Approved” shall apply to the medical devices inside China;
The form of being “Imported” shall apply to the medical devices from abroad;
The form of being “Permitted” shall apply to the medical devices from the regions of Taiwan, Hong Kong and Macao;
aaa shall be the year in which the registration is approved;
shall be the category of product administration;
a shall be the number of the product variety;
aaa shall be the registration sequence number.
A medical device registration certificate shall be attached with a “Medical Device Registration Form” (see Appendix 1 of these Measures),
which shall be used simultaneously with the medical device registration certificate.
Article 6
A manufacturing enterprise may obtain a medical device registration certificate after its application for medical device registration
has been approved, and shall bear the corresponding legal obligations.
A person handling an application for medical device registration shall be entrusted by a manufacturing enterprise, have the corresponding
professional expertise, and be familiar with the laws, regulations, rules and technical requirements on medical device registration
and administration.
A manufacturing enterprise outside China shall, when applying for the registration of medical devices from abroad, appoint an institution
inside China as its agent, which shall assume legal liabilities accordingly; in addition, the manufacturing enterprise outside China
shall entrust a legal entity inside China with corresponding qualification or entrust its office in China to undertake after-sale
services for the medical devices.
Article 7
With respect to the medical devices under application for registration, there shall be applicable product standards. For this purpose,
national standards or industry standards may be adopted or standards for registered products may be formulated, however the standards
for registered products may not be lower than national standards or industry standards.
The standards for registered products shall be compiled in accordance with the requirements prescribed by the State Food and Drug
Administration for standard administration of medical devices.
Article 8
A manufacturing enterprise applying for registration of medical devices on Category II or Category III shall meet the production conditions
prescribed by the State Food and Drug Administration or the relevant quality system requirements.
Chapter II Medical Device Registration Test
Article 9
For the medical devices on Categories II and III, registration test shall be carried out by a medical device testing institution accredited
by the State Food and Drug Administration jointly with the State General Administration of Quality Supervision, Inspection and Quarantine,
and only after the medical devices have been tested as meeting the applicable product standards may they be used for clinical trial
or apply for registration.
The catalogue of the medical device testing institutions accredited by the State Food and Drug Administration jointly with the State
General Administration of Quality Supervision, Inspection and Quarantine (hereinafter referred to as medical device testing institutions)
shall be separately promulgated.
Article 10
A medical device testing institution shall, within the testing scope recognized by the State Food and Drug Administration and the
State General Administration of Quality Supervision, Inspection and Quarantine, and according to the applicable product standards
for manufacturing enterprises (including applicable national standards, industry standards, or standards made by the manufacturing
enterprise for registered products), carry out registration test for the products under application, and issue a testing report.
The medical devices which have not been included into the scope of authorized test by medical device testing institutions shall be
tested by a capable testing unit appointed by a corresponding registration and approval organ.
The registration test of medical devices from abroad shall apply the “Provisions on Registration Test of Medical Devices from Abroad”.
Article 11
The products tested within one registration unit shall be the typical products which can represent security and utility of other products
within this same registration unit.
Article 12
With respect to the products of the same category which are produced by one manufacturing enterprise with the same raw materials,
if the production techniques and anticipated purposes remain unchanged, no biocompatibility trial needs to be carried out during
the biological evaluation of the products at the time of re-registration.
With respect to the products of the same category which are produced by one manufacturing enterprise with raw materials having passed
biological evaluation, if the production process or anticipated purpose remains unchanged, or if there is no new potential biological
risks, no biocompatibility trial needs to be carried out during the biological evaluation of the products at the time of application
for registration.
Article 13
Those applying for medical device registration under Category II or Category III may, when meeting the following conditions simultaneously,
be exempted from registration test:
(1)
The basic theory, main functions and structure, materials used, and anticipated purposes of the medical devices under application
for registration and those of the medical devices already approved for registration from the same enterprise fall in the same category;
(2)
The manufacturing enterprise has already passed the inspection on the quality management standards for the production of medical devices
or has obtained the quality system certification for medical devices, and is able to provide the testing report accredited by the
original institution which has examined the production conditions of the enterprise;
(3)
When compared with products on the same category which have been approved for registration and have passed registration test, if there
is no change in the security or utility with the medical devices under application for registration, or although there is change
in the security or utility, both the changed part and the part causing other relevant changes in the security or utility of the products
have passed the test carried out by the medical device testing institution;
(4)
No serious ill incident is found with the products which have been approved for registration on the same category by the same enterprise
under the monitoring conducted as prescribed;
(5)
No records of disqualification are kept on its products of the same category which have been approved for registration within 1 year
from the selective supervision and inspection by the (food) drug administration on the quality of the product; and
(6)
The medical devices from abroad have been approved by the corresponding governmental medical device authority to be put on market.
Article 14
Those applying for re-registration of medical devices or products on Category II or Category III may, when meeting the following conditions
simultaneously, be exempted from registration test:
(1)
The basic theory, main functions and structure, materials used, and anticipated purpose of the medical devices under application for
re-registration and those of its medical devices approved for registration fall in the same category;
(2)
The manufacturing enterprise has passed the inspection on its quality management rules for production of medical devices or has obtained
the quality system certification for medical devices, and is able to provide the testing report accredited by the original institution
for examination of enterprise production conditions;
(3)
When compared with the original registered products which have passed registration test, there is no change in the security or utility
with the medical devices under application for re-registration, or although there is change in security or utility, both the changed
part and the part causing other relevant changes in the security or utility of the products have passed the test carried out by the
medical device testing institution;
(4)
No serious ill incident is found under the monitoring conducted as prescribed upon the medical devices under application for re-registration
within the original validity period for the medical device registration certificate; and
(5)
No records of disqualification are kept on its originally registered medical devices within 1 year from the selective product quality
supervision and inspection made by the (food) drug administration.
Article 15
With respect to large medical devices which have been approved by the medical device authority of a foreign government to be put on
the market, but whose installation place is under particular requirements and whose testing is difficult, the manufacturing enterprise
may apply for temporary delay of testing, and apply for supplementary testing after obtaining the medical device registration certificate.
With respect to the products whose testing is temporarily delayed according to the preceding paragraph and which are approved for
registration, the manufacturing enterprise must complete the registration test after the first medical device enters into China and
before it is put into use. Only after they have been tested as qualified may they be put into use.
Chapter III Clinical Trial of Medical Devices
Article 16
Those manufacturing enterprises applying for registration of medical devices on Category II or Category III shall submit clinical
trial documents.
The method of submitting clinical trial documents shall be in accordance with the “Provisions on Itemization of Clinical Trial Documents
for Medical Device Registration” (see Appendix 12 of these Measures).
Article 17
Those enterprises carrying out clinical trial of medical devices inside China shall strictly implement the “Provisions on Clinical
Trial of Medical Devices”.
Article 18
For the medical devices whose clinical trial is carried out inside China, the clinical trial documents shall include clinical trial
contract, clinical trial program and clinical trial report.
When deeming it as necessary, a (food) drug administration may require the manufacturing enterprise to submit the directions for clinical
trial, a consent letter indicating the knowledge about the information, and the original clinical trial records.
Chapter IV Application for, Examination and Approval of Medical Device Registration
Article 19
When applying for medical device registration, the applicant shall, according to the classification of medical devices, file an application
to the corresponding (food) drug administration as prescribed in Article 4 of these Measures, and shall fill out the application
form for medical device registration, and submit the application documents pursuant to the corresponding requirements in Appendix
2, Appendix 3, Appendix 6, Appendix 8 or Appendix 9 of these Measures. The application documents shall be in Chinese. When submitting
the application documents translated from a foreign language, the original text shall be provided at the same tome.
The medical device directions submitted by the applicant shall conform to the “Provisions on the Administration of Medical Device
Directions, Labels and Packing Marks”.
The applicant shall be responsible for the authenticity of all contents in the application documents.
Article 20
The (food) drug administration shall, after receipt of an application, deal with the application in light of the following circumstances:
(1)
If the matters in application do not fall in the scope of its powers in accordance with the law, it shall immediately make a decision
on not accepting the application, and inform the applicant to apply to other relevant administrative organ;
(2)
If any error which may be corrected on site exists in the application documents, it shall permit the applicant to make corrections
on site;
(3)
If the application documents are incomplete or do not meet the requirements for formal examination, it shall issue a “Notice on Supplementing
Documents” to the applicant on site or within 5 working days, and inform the applicant once and for all the contents to be supplemented.
If it fails to inform the applicant within the time limit, it shall be regarded as having accepted the application as of the date
when the application documents are received;
(4)
If the application documents are complete and meet the requirements for formal examination, or the applicant has submitted all the
supplemented application documents as required, the application shall be regarded as having been accepted.
The (food) drug administration shall, whether or not accepting the application for medical device registration, issue a “Notice on
Accepting the Application” or “Notice on Not Accepting the Application” affixed with its special stamp and indicated with the date.
Article 21
A (food) drug administration shall, after accepting the application for medical device registration, make substantive examination
on the application within the time limit prescribed in Article 22 of these Measures, and make a written decision on whether to approve
the registration. If the application is examined as conforming to the provisions and the registration is approved, the (food) drug
administration shall issue the medical device registration certificate within 10 working days as of approving the decision in writing.
If the application is examined as not conforming to the provisions, the (food) drug administration shall make a written decision
on not approving the registration, state the reason, and meanwhile inform the applicant of the right to lawfully apply for administrative
reconsideration or to bring an administrative lawsuit.
Article 22
The (food) drug administration at the level of a city divided into districts shall, within 30 working days as of accepting an application,
make a decision on whether to approve the registration.
The (food) drug administration of a province, autonomous region, or municipality directly under the Central Government shall, within
60 working days as of accepting an application, make a decision on whether to approve the registration.
The State Food and Drug Administration shall, within 90 working days as of accepting an application, make a decision on whether to
approve the registration.
If, in the process of examination of an application for registration, it is necessary to hold a test, expert appraisal or hearing,
the time needed for it shall not be calculated into the time limit prescribed in this Article. The (food) drug administration shall
inform the applicant in writing of the time needed.
Article 23
With respect to the medical devices from abroad which are not permitted to be put on market, the applicant may apply for registration
with reference to the requirements for technical examination for registration of products of the same category inside China (see
Appendix 8 and Appendix 9 of these Measures for necessary documents to be submitted).
Article 24
A (food) drug administration shall, when making technical examination on the application documents for medical device registration,
send a one-time written notice on supplementing documents, if the manufacturing enterprise needs to supplement documents.
A manufacturing enterprise shall, within 60 working days, supplement all the documents as required by the notice for once, and the
time for supplementing documents shall not be calculated into the time limit for the (food) drug administration to make substantive
examination. If the manufacturing enterprise fails to supplement the documents within the prescribed time limit and has no justifiable
reason, the examination shall be terminated.
Article 25
Where the examination of an application for registration is terminated, the applicant may not file a second application within 6 months
as of the termination of the examination.
Article 26
Where a manufacturing enterprise has any objections to the contents in the notice on supplementing documents, it may, within the prescribed
time limit, propose written opinions to the (food) drug administration, state the reasons, and provide technical support documents,
so that the (food) drug administration may make a decision from examination.
Article 27
The registration units of medical device products shall, in principle, be divided on the basis of technical structure, performance
index and anticipated purpose.
Article 28
With respect to the medical devices registered as components, the applicant shall state the recommended product to be used along with
such components, as well as the name, model and specifications of such components.
For a whole machine assembled with components approved for registration, the whole machine registration procedures must be fulfilled.
With respect to the medical devices registered as a whole machine, the enterprise involved shall, when applying for registration,
list the main configurations. In the event that the performance or specifications of the components of a certain main configuration
are changed, the manufacturing enterprise involved shall make re-registration of the whole machine.
With respect to the medical devices registered as a whole machine, if the combined components listed in the column of “Product Performance,
Structure and Composition” in the attached schedule of the medical device registration certificate are sold independently on the
condition that neither the form of combination nor the anticipated purpose is changed, specific registration may be exempted.
Article 29
A (food) drug administration shall announce the conditions, procedures and time limit for the medical device registration, a catalogue
of all documents to be submitted, and a sample version of the application letter, etc. on the administrative organ’s website as well
as in the work place for medical device registration.
Article 30
A (food) drug administration shall, when examining an application for medical device registration, announce the process of the examination
and result of approval. The applicant and an interested party may submit its/his written opinions on the matters directly related
to its/his major benefits, make statements and contentions.
Article 31
The State Food and Drug Administration shall regularly publish on its governmental website the catalogue of the medical devices which
have been approved for registration, for the public’s reference.
Article 32
Where an application for medical device registration is directly involved with the major benefit relationship between the applicant
and others, the (food) drug administration shall inform the applicant and the interested party that it/he may, in accordance with
the laws, regulations, and other provisions of the State Food and Drug Administration, have the right to apply for a hearing. When
examining an application for medical device registration, the (food) drug administration shall announce to the public the major issues
for permission which it deems to be involved with public benefits, and shall hold a hearing.
Chapter V Re-registration of Medical Devices
Article 33
When the validity period of a medical device registration certificate has expired, and the manufacturing enterprise needs to continue
selling or using the medical devices, it shall, within 6 months prior to the expiry of the validity period of the medical device
registration certificate, apply for re-registration. If it fails to do so within the time limit, registration test on the products
shall be made at the time of re-registration.
Article 34
In the event of any change in the following contents on a medical device registration certificate, the manufacturing enterprise shall
apply for modification and re-registration within 30 days as of the change:
(1)
model and specifications;
(2)
address of production;
(3)
product standards;
(4)
product performance, structure and composition;
(5)
scope of application of the products.
Article 35
If, within the validity period of a medical device registration certificate, the category for administration of the product is changed,
the manufacturing enterprise shall, within 6 months, apply to the corresponding (food) drug administration for modification and re-registration
on the basis of the modified class.
Article 36
Whichever manufacturing enterprise applies for re-registration of medical devices shall fill out the medical device registration application
form, and shall, pursuant to the requirements in Appendix 4, Appendix 5 or Appendix 7 of these Measures, submit application documents
to the (food) drug administration.
The procedures for acceptance, examination and approval of applications for re-registration shall, in case of no relevant provisions
in this Chapter, be governed by the relevant provisions of Chapter IV of these Measures.
Article 37
Medical devices under any of the following circumstances shall not be re-registered:
(1)
The requirements proposed according to the relevant provisions of the State Food and Drug Administration by the (food) drug administration
at the time of approval of being put on market have not been fulfilled;
(2)
The medical devices are re-appraised by the State Food and Drug Administration to be eliminated;
(3)
The medical device registration certificate has been revoked in accordance with the “Regulations on the Supervision and Administration
of Medical Devices”.
Chapter VI Modification and Re-issuance of Medical Device Registration Certificates
Article 38
Where the contents of a medical device registration certificate has any of the following changes, the manufacturing enterprise shall,
within 30 days as of the occurrence of the change, apply for modification of the medical device registration certificate:
(1)
change of the name of the manufacturing enterprise, but without any change with the entity;
(2)
change of the registered address of the manufacturing enterprise;
(3)
literal change of the production address;
(4)
literal change of the product name or commodity name;
(5)
literal change of the model or specifications;
(6)
literal change of the post_title or code of the product standards;
(7)
change of the agent; or
(8)
change of the after-sale service office.
Article 39
Those manufacturing enterprises applying for the modification of a medical device registration certificate shall fill out the application
form for modification of the medical device registration certificate, and shall, pursuant to the requirements in Appendix 10 of these
Measures, submit the relevant documents and statements to the original registration and approval organ. The original registration
and approval organ shall carry out a formal examination on the application documents, inform once and for all either on site or within
5 working days the applicant of all the contents to be supplemented, and issue the “Notice on Accepting the Application” to the applicant
who meets the requirements.
Article 40
The original registration and approval organ shall, within 20 working days after accepting the application for modification, make
a written decision on whether to approve the modification or not. If the application is examined as qualified for modification, the
original registration and approval organ shall issue a modified medical device registration certificate, and write off the original
medical device registration certificate. If, however, the application is examined as unqualified, the original registration and approval
organ shall make a written decision on not approving the modification, state the reasons, and meanwhile inform the applicant of the
right to lawfully apply for administrative reconsideration or to bring an administrative lawsuit.
A modified medical device registration certificate shall have the original number as its number, followed by the word “modified” in
brackets.
The expiry date of the validity period for a modified medical device registration certificate shall be the same as that for the original
medical device registration certificate. The enterprise concerned shall apply for re-registration at the expiry of the validity period.
Article 41
Where a medical device registration certificate is lost or damaged, the manufacturing enterprise shall, pursuant to the requirements
in Appendix 11 of these Measures, submit the relevant documents and statements, and apply to the original registration and approval
organ for re-issuance of the certificate.
Chapter VII Supervision and Administration
Article 42
The (food) drug administration responsible for examination and approval of medical device registration shall carry out examination
and grant approval pursuant to the prescribed procedures, and make a decision on whether to approve the registration or not. Any
(food) drug administration examining and approving the registration in violation of provisions shall be lawfully investigated for
administrative liabilities.
Article 43
Where a local (food) drug administration at the level of city divided into districts or above approves medical device registration
by violating these Measures, the (food) drug administration at the higher level shall order it to make a correction within a time
limit. If it fails to make a correction within the time limit, the (food) drug administration at the higher level may directly revoke
the medical device registration certificate by announcement. The medical devices whose medical device registration certificate has
been revoked may not be sold or used any longer. If they have been sold or used, they shall be treated by the enterprise under the
supervision of the local (food) drug administration at the county level or above.
Article 44
A (food) drug administration at the provincial level or above shall make technical re-appraisal on the medical devices on market,
and shall, on the basis of the result from technical appraisal, make a decision on revoking the medical device registration certificate
of the medical devices which cannot achieve the anticipated purpose of use and whose security and validity can not be guaranteed.
In addition, the said (food) drug administration shall announce the revocation to the public. The medical devices whose medical device
registration certificate has been revoked may not be sold or used any longer. If they have been sold or used, they shall be treated
by the enterprise under the supervision of the local (food) drug administration at the county level or above.
Article 45
In case of any of the circumstances in Article 70 of the “Administrative License Law of the People’s Republic of China”, the original
registration and approval organ shall lawfully write off the medical device registration certificate.
Chapter VIII Legal Liabilities
Article 46
If any enterprise tries to obtain a medical device registration cert
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