A. The Direction for the Application Form of
Registration
1.
All the contents filled in shall be in both Chinese and
English；
2.
Upon the application, the form shall be printed
；
3. All
the items must be completely filled in, and as for the
vacant items, “/” shall be used to show inapplicability；
4.
The Name of Devices and Model, Name and Address of
Manufacturer must be unanimously the same as the
contents carried in the documents approved by the
government of the Country (Region) of Origin, and must
be consistent with the contents concerned carried in the
test reports, operation manual of the product, and so
on;
5.
Any enterprise shall not set up the format for the
Application Form for Registration without authorization.
The Application Form may be downloaded from the website:
http://www.sda.gov.cn/ylqjzc/setup.exe
B. About the Application Documents
1.
The certificate of the legal production
qualification of the Manufacturer.
1)
The certificate issued by the government agency
of the Country (Region)of Origin to authorize the
Manufacturer to engage in the production and
distribution of medical devices（equivalent
to the business certificate or manufacturing enterprise
license）.
2)
The certificates may be submitted in the form of the
copy thereof, subject to the seal by the original
issuing agency or the notarization by the local
notarization agency.
2.
The qualification certificate of the applicant
1)
Business certificate of the Applicant；
2)
The certificate of commission given by the
Manufacturer to the agent for registration
3.
The certificate recognized or approved by the government
of the Country (Region) of Origin to authorize the
products as medical devices to enter into the market of
the country.
1)
The certificate recognized or approved by the
government of the Country (Region) of Origin to
authorize the products as medical devices to enter into
the market of the country.
(1)
In case of any special authorization documents specified
by the government of Country (Region) of Origin for
medical devices to be put into the market of the Country
(Region) of Origin, such formal authorization documents
as 510 K or PMA of the U.S. FDA, and the CE certificate
of the EU shall be submitted.
(2)
In case of one of the following circumstances:
a. That no special authorization documents are required
to handle by the government of the Country of Origin；
b. That in case of any change to the Products on the
basis of the Products specified in the original special
authorization documents, due to the difference in the
partition of registration elements, no re-application is
required by the government of the Country of Origin, the
enterprise shall give a statement, and provide the
following certificates:
①The free sale certificate issued by the government; or
②the certificate to the foreign government; and
③the enterprise self-guarantee declaration in
conformance with the provisions concerned of local
regulations
2)
In case of no document issued by the government
of Country of Origin to authorize the medical devices to
be put into market
(1)
If the products shall be regulated as medical devices in
the Country of Origin, but they have not been authorized
by the government of Country of Origin to be put into
market, the Standards of the Products to be Registered
authorized by the competent department shall be
submitted; in case of Products of Class II or Class III,
the full-performance test report, Clinical Trial
Reports, risk analysis reports within the territory of
China and other documents necessary for the registration
of import products shall be submitted, subject to which,
the application may be accepted and after the
acceptance, the on-site inspection of the production
quality system will be arranged.
(2)
If the products shall be regulated as medical devices in
the Country of Origin，but
need not be authorized by the government of Country of
Origin to put in the market because they are produced
specifically for China , the first paragraph of this
Article shall be applied.
(3)
If the products fail to be regulated as medical devices
in the Country of Origin but the Products are defined as
medical devices in China in accordance with the
definition of medical devices, the first paragraph of
this Article shall be applied.
3)
the certificates may be submitted in the form of
the copy thereof, subject to the seal by the original
issuing agency or the notarization by the local
notarization agency.
4.
The Standards of the Products to be Registered shall
apply the Provisions for the Management of the Medical
Devices Standards
1)
The methods for the implementation of “Only the
Original of the Standards Sealed or Signed by the Legal
Representative may be submitted”:
(1) Standards of the Products to be
Registered may be sealed through the following
three methods:
a. to be sealed by the Manufacturer;
b. to be sealed by the office or
representative office of the Manufacturer in China；
c. to be sealed by the unit in charge of
the conclusion, arrangement, drafting of the
Standards of the Products to be
Registered commissioned by the Manufacturer.
And in the certificate of commission, it
shall be clearly indicated that “the ×××
Unit is commissioned to be responsible
for the completion of the Standards of the
Products to be Registered in China, and
the Manufacturer shall be responsible for
the quality of the Products” .
( (2) the Definition of the Legal Representative：in
accordance with the international
practices, " the signature and seal of
the Legal Representative” of the
Manufacturer abroad may be signed and
sealed by the senior official in charge of
the corresponding business activities.
2)
The Standards of the Products to be Registered
reviewed, codified, and recorded by SDA Standard and
Technical Committee；
3)
As for the Products with national standard and
industrial standards, the manufacturer shall, with the
implementation of the standards mentioned above, based
on its own specialties, supplement and add corresponding
requirements, formulate the Standards of the Products to
be Registered，and
assure the safety and effectiveness of the operation of
the Products；
if the enterprise thinks that no requirements on safety
need to be added, and that the direct adoption of
national standard and industrial standards as the
manufacturer Standards of the Products to be Registered
is sufficient for the assurance of the safety and
effectiveness of the products, the manufacturer shall
submit a statement justifying that without any increase
and improvement in the standard index on the basis of
national standard and industrial standards, the safety
and effectiveness of the products for application can be
assured, declaring to bear the quality liabilities after
the launching of the products and carrying the model,
specification of the Products. As for the products with
ISO or IEC standards, the manufacturer shall convert the
standards to the Standards for the Products to be
Registered.
5. Operation Manual of the Products
1)
The methods for the implementation of “Only the
Original of the Operation Manual Sealed or Signed by the
Legal Representative may be submitted”:
(1)
The Operation Manual of the Products of Class II or
Class III shall be sealed by the Manufacturer；the
Operation manual of the Products of Class I shall not be
sealed.
(2)
The Definition of the Legal Representative：in
accordance with the international practices, " the
signature and seal of the Legal Representative” of the
Manufacturer abroad may be signed and sealed by the
person in charge of the corresponding business
activities.
2)
Implementation of the “Administrative Provisions
on the Operation Manual of Medical Devices” .
The operation manual of medical devices shall implement
the national standards provided in “Operation Manual for
Industrial Products--General provisions”. In accordance
with the specialty of the medical devices , the
following contents shall be included:
（1）
Name of Product, Name, Address, Postal Code and Tel. of
the Manufacturer；
（2）
Registration number of the products;
（3）
Applied product standards；
（4）
The main structure, performance, specification of the
Products；the
usage, scope of application, contraindication ,
precautions, cautions and suggestions of the Products;
（5）
Interpretation of the figures, logos, abbreviations,
etc. of the labels and marks；
（6）
Illustration and graphic expression of the Installation
and Operation;
（7）
The Maintenance methods, special storage methods and
length of life of the Products；
（8）
other necessary contents specified in the Product
Standards.
6. The Type test Report
presented by the medical devices quality test
agency
recognized by the State Drug Administration within
the recent one year
（Applied
to
the Products of Class II and Class III）
1)
About Test-after-Registration of import products
The following import products may apply to
Test-after-Registration
：
（1）X-Ray
Computerized Topography（C
T）；
（2）Positron
Emission Computerized Topography
（PET）；
（3）Single
Photon Emission Computerized Topography
（SPECT）；
（4）Extraneous
Shock Wave Crusher；
（5）Color
Ultrasonic Diagnostic Scanner；
（6）Large
Laser Therapy Apparatus；
（7）Large
X-Ray Diagnostic Equipment；
（8）Automatic
Biochemical Analyzer；
（9）Cobalt
60 Therapy Unit；
（10）Gamma
Knife；
（11）Medico-
electronic Linear Accelerator；
（12）Simulated
Positioner；
（13）Magnetic
Resonance Imaging System
To apply Test-after-Registration of import products，the
Manufacturer shall submit an application for the Test
and that the Products shall commit to complete the Test
at first, as the product gets into the Chinese market.
If the product fails to pass the following test, the
registration certificate shall be cancelled by the
original issuing agency.
2)
About the Scope of Acceptance for Examination of
the Examination Center
The test on placing the Products under the competent
unit shall be determined in accordance with the
“government certified Scope of Acceptance for
Examination of the Examination Center”. The enterprise
may at its option select one among the qualified
examination centers. In case of any ambiguity on the
catalog of the Scope of Acceptance for Examination of
the Examination Center, a written report shall be
submitted to the office of acceptance, and the office
will deliver the case to the competent department to
designate one center for test.
3)
Under the following Circumstances, no test is
required：
(1)
Among the laboratory equipment, the electrophoresis
apparatus、centrifuge、Ultra
Low temperature refrigerator，paraffin
slicing machine，paraffin
embedding machine, cell centrifuge smearing machine, and
full automatic dying machine no clinical trial reports
and Product Type Test Reports issued by the medical
devices quality test agency and recognized by the State
Drug Administration are required to be provided .
(2)
The Products of Class I in accordance with catalog of
classification of the medical devices Products of China.
4)
As for the medical devices in conformance with
both of the following conditions the application for
exemption from test may be made：
(1)
The domestic enterprise has received the authentication
certificate of GB/T19001+YY/T0287 or GB/T19002+YY/T0288
issued by the quality system authentication agency
recognized by the State Drug Administration, and the
quality system concerned has covered the Products for
application.
The Products abroad has received the authorization of
launching from the competent department of the Country
of Origin, and the certificate is still valid, and the
enterprise has been authenticated in accordance with the
ISO 9000 Serial Standards (or equivalent).
(2)
the difference between the structure and performance of
the Products for application and those of the registered
products of a kind is insignificant in terms of safety
and effectiveness.
(3)
the Products for application are not implantable device.
(4)
no radioactive sources exist in the Products for
application.
(5)
In case of any malfunction，no
grave injury accidents such as death of and body injury
of the user or operator will be caused.
7. The clinical trial report of medical devices, the
methods on the provisions of the report should be
applied in accordance with the “Provisions for the
‘Subitem of Clinical Reports’ for the Registration of
Medical Devices”. The clinical trial shall be
implemented in accordance with the “Provisions for the
Clinical Trial Management of Medical Devices”.
1)
Prior to the promulgation of the new Clinical
Trial Management Methods, the quantity and trial period
of the Clinical Trial shall be implemented in accordance
with the “Interim Provisions for the Clinical
Verifications of Medical Devices” issued by the State
Drug Administration in 1997.
If in accordance with the requirements for sub-item
concerned, the provisions for Clinical Reports are not
necessary, the enterprise may make a statement upon the
application.
2)
Clinical Reports of Import Products in the Country of
Origin may be provided through the following two methods：
(1)
in case that clinical reports are required to submit
upon the authorization of launching by the Country of
Origin, the clinical reports upon the authorization of
launching by the Country of Origin shall be provided；
(2)
in case that no clinical reports are required to submit
upon the authorization of launching by the Country of
Origin, the Manufacturer shall make a statement that no
clinical reports are required to submit upon the
authorization of launching by the Country of Origin，and
guarantee the authenticity thereof. In the event, the
enterprise may submit the Clinical Trial Reports and
documents after the launching of the Products.
3)
Under the following Circumstances, no clinical reports
are required.
(1)
In accordance with the clear division of work in the
State Drug Administration, Among the IVD reagent
approved and registered by Department of Medical Devices，in
case of those for the diagnosis of hepatitis and AIDS,
the Clinical Trials shall be carried out in designated
medical institutions (quantity and statistical methods
undetermined); as for other types of IVD reagent,
generally no Clinical Reports are required to be
provided.
(2)
As for condom Products, no Clinical Reports are required
to be provided.
(3)
Among the laboratory equipment, the electrophoresis
apparatus、centrifuge、Ultra
Low temperature refrigerator，paraffin
slicing machine，paraffin
embedding machine, cell centrifuge smearing machine, and
full automatic dying machine no clinical trial reports
and Product Type Test Reports issued by the medical
devices quality test agency and recognized by the State
Drug Administration are required to be provided.
(4)
The Products of Class I in accordance with the catalog
of classification of the medical devices Products of
China.
8. The Product Quality Guaranty presented by the
Manufacturer, to promise that the quality of the
products registered and sold in China are unanimously
the same as that of the identical products put into
market in the Country (Region) of Origin.
9. The certificate of commission for the After-Sale
Service Agency designated in China, the letter of
commitment and business certificate of the commissioned
agency.
1)
Certificate of commission of After-Sale Services
(1) Presented by the Manufacturer;
(2) The name of the Products shall be indicated
clearly in the certificate of
commission;
(3) In case of multilevel commissioning, the
consignor at every level shall provide
the certified documents of the
Manufacturer.
2)
The letter of commitment
(1) The contents promised in the letter of commitment
shall be consistent with the matters consigned in the
certificate of commission;
(2) The letter of commitment shall also contain：
a. Liabilities for reporting the Product quality
accidents；
b. Liabilities for actively contacting with the State
competent department in charge of the registration of
medical devices；
3)
The qualification certificate of after-sale
service units
Business certificate（the
scope of business shall contain corresponding technical
service items）or
the registration certificate of the representative
agency in China of the manufacture.
10. The Self-Guarantee Declaration on the authenticity
of the materials submitted.
" The Self-Guarantee Declaration on the authenticity of
the materials submitted " shall be presented by the
manufacturer.
1)
Presented by the manufacturer or the office
thereof in China；
2)
A list of the materials submitted
；
3)
Commitment on the Liabilities.
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