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B. SFDA Registration Services in China
- Registration procedure table
- Product Registration Process Chart
- Service content of medical devices registration more info. >>>
- Budget & Timetable more info. >>>
- Initial registration of import products more info. >>>
China Marketing research and analysis services
AdvancedMedicals® is also working as a domestic and international(China) marketing research and consulting firm specializing in
global medical device and equipment fields. AdvancedMedicals® focuses on providing comprehensive research and valuable
market insight in "hot" areas which are identified by our clients.
Recognizing the convergent nature of today's medical equipment markets, AdvancedMedicals® has gathered together a team of
industry leading experts who are able to work across traditional boundaries and provide businesses with the strategic competitive
intelligence needed to make long-term business decisions. We are focusing on the following subjects:
• Investigate and evaluate all potential markets.
• Collect first-hand market information
• Interview Treating Physicians
• Vocational/Rehabilitation Counseling and Assessment
• Economic Assessment of Future Costs
• Clinical Trial Exhibits
Our expertise covers a broad spectrum of medical equipments ranging from large diagnostic and therapeutic machines to delicate
surgical instruments used in minimally invasive surgery.
By incorporating published research with supplemental primary and secondary data drawn either from our own database or from
extensive external sources, AdvancedMedicals® analysts have the ability to react in "real time" to a Customer's request for
customized research.
AdvancedMedicals® analysts work closely with the Client's appointed representatives to scope out a project, plan the milestones
and deliverables, and most importantly, establish a clear and open channel of communication to report progress and receive
feedback so as to meet the deadline of the service.
Registration procedure table
Product Registration Process Chart
Budget & Timetable
(MEDICAL DEVICE CLASS II & CLASS III)
1. Cost of medical device registration agency service taken by AdvancedMedicals®: $ 5,500.00.
2. Cost of professional medical literature translation taken by AdvancedMedicals®: $90 per thousand English wards.
3. Cost of drawing technical specification of product taken by the statutory medical device testing institutions of China: 7,000-12,000
RMB/$853 - $1462 (30 working days).
4. Cost of medical device test taken by the statutory medical device testing institutions of China: 7,000-12,000RMB /$853 - $1462(45
working days);
5. Cost of medical device registration taken by SFDA: 3,000 RMB/$366 per Certificate (90 working days).
The registration time is 4.5 months since all documents including the technical specification and medical device test report issued by
the statutory medical device testing institutions of China are provided; the registration time is 7.5 months since the client designates
AdvancedMedicals® to do registration in SFDA; the registration time is shorter than 4.5month in Medical device Class I
registration; the certificate is valid for 4 years.
The above budget and timetable of registration is just for the general medical device, perhaps the budget or timetable of particular
medical device registration is over or below the above. All other cost or fee except for fee of attorney is taken directly by the SFDA
and its statutory medical device testing institutions. This is only the evaluation of the attorney and is not the guarantee of the
attorney; this is not the precondition of the contract.
Service content of medical devices registration
1. Preparation work before registration
a. documents assessment and sorting
b. products classification: classify the products according to the regulation and product anticipated
function and make concrete registration procedure.
C document translation: translate all the necessary documents into Chinese. The time needed will depend
on the amount of the documents and language classification.
2. Product specification and relevant documents compiling
The product specification should be provided before product type testing. When required by the clients, we
will compile the product specification. It will take 1-2 weeks/ product.
3. Products type testing
We will assist you with the product type testing in the testing center correspondent to product type. There
are ten more authorized testing center with different testing scope. Time and cost will depend on the actual
needs.
4. Clinical documents assessment and clinical trial
Some home-made and foreign products need clinical trial in China. We will help the clients to choose at least
two qualified hospitals according to the requirements of SFDA to do clinical trial. First, to make clinical
agreement and then clinical plan, and to track the course of the registration. Time and cost will depend on
the clinical agreement and statistic result of the product.
5. Product registration
90 working days according to the official regulation
6. Information feedback
Complement necessary documents, and help the clients to do the expert examining.
7. Certificate issuing and delivery
After verifying the relevant fee, we will delivery the certificate within 1 week.
Initial registration of import products
A. The Direction for the Application Form of Registration
a. All the contents filled in shall be in both Chinese and English
b. Upon the application, the form shall be printed
c. All the items must be completely filled in, and as for the vacant items, “/” shall be used to show inapplicability
d. 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;
e. 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” .
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:
a. X-Ray Computerized Topography C T
b. Positron Emission Computerized Topography PET
c. Single Photon Emission Computerized Topography SPECT
d. Extraneous Shock Wave Crusher
e. Color Ultrasonic Diagnostic Scanner
f. Large Laser Therapy Apparatus
g. Large X-Ray Diagnostic Equipment
h. Automatic Biochemical Analyzer
i. Cobalt 60 Therapy Unit
j. Gamma Knife
k. Medico- electronic Linear Accelerator
l. Simulated Positioner
m. 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 with 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.
