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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: www.cmdi.gov.cn. 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” . （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) |
