Laws & Regulations/
Initial registration of import products

A.The Direction for the Application Form of Registration

1. All the contents filled in shall be inboth Chinese and English;

2. Upon the application, the form shall beprinted;

3. All the items must be completely filledin, and as for the vacant items, / shall be used to show inapplicability;

4. The Name of Devices and Model, Name andAddress of Manufacturer must be unanimously the same as the contents carried inthe documents approved by the government of the Country (Region) of Origin, andmust 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 theformat for the Application Form for Registration without authorization. TheApplication 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 legalproduction qualification of the Manufacturer.

1.1 The certificate issued by thegovernment agency of the Country (Region)of Origin to authorize theManufacturer to engage in the production and distribution of medical devicesequivalentto the business certificate or manufacturing enterprise license.

1.2 The certificates may be submitted inthe form of the copy thereof, subject to the seal by the original issuingagency or the notarization by the local notarization agency.

2. The qualification certificate of theapplicant

2.1 Business certificate of the Applicant;

2.2 The certificate of commission given bythe Manufacturer to the agent for registration

3. The certificate recognized orapproved by the government of the Country (Region) of Origin to authorize theproducts as medical devices to enter into the market of the country.

3.1 The certificate recognized or approvedby the government of the Country (Region) of Origin to authorize the productsas medical devices to enter into the market of the country.

3.1.1 In case of any special authorizationdocuments specified by the government of Country (Region) of Origin for medicaldevices to be put into the market of the Country (Region) of Origin, suchformal authorization documents as 510 K or PMA of the U.S. FDA, and the CEcertificate of the EU shall be submitted.

3.1.2 In case of one of the followingcircumstances:

a. That no special authorization documentsare required to handle by the government of the Country of Origin;

b. That in case of any change to theProducts on the basis of the Products specified in the original specialauthorization documents, due to the difference in the partition of registrationelements, no re-application is required by the government of the Country ofOrigin, the enterprise shall give a statement, and provide the followingcertificates:

(1)  The free sale certificateissued by the government; or

(2)   The certificate to the foreigngovernment; and

(3)  The enterprise self-guaranteedeclaration in conformance with the provisions concerned of local regulations

3.2 In case of no document issued by thegovernment of Country of Origin to authorize the medical devices to be put intomarket

(1) If the products shall be regulatedas medical devices in the Country of Origin, but they have not been authorizedby the government of Country of Origin to be put into market, the Standards ofthe Products to be Registered authorized by the competent department shall besubmitted; in case of Products of Class II or Class III, the full-performancetest report, Clinical Trial Reports, risk analysis reports within the territoryof China and other documents necessary for the registration of import productsshall be submitted, subject to which, the application may be accepted and afterthe acceptance, the on-site inspection of the production quality system will bearranged.

(2)If the products shall beregulated as medical devices in the Country of Originbut need notbe authorized by the government of Country of Origin to put in the marketbecause they are produced specifically for China , the first paragraph of thisArticle shall be applied.

(3)If the products fail to beregulated as medical devices in the Country of Origin but the Products aredefined as medical devices in China in accordance with the definition ofmedical devices, the first paragraph of this Article shall be applied.

3.3 The certificates may be submitted inthe form of the copy thereof, subject to the seal by the original issuingagency or the notarization by the local notarization agency.

4. The Standards of the Products to beRegistered shall apply the Provisions for the Management of the Medical DevicesStandards

4.1 The methods for the implementation of“Only the Original of the Standards Sealed or Signed by the LegalRepresentative may be submitted”:

4.1.1 Standards of the Products to be registeredmay be sealed through the following three methods:

a.to be sealed by theManufacturer;

b.to be sealed by the office orrepresentative office of the Manufacturer in China;

c.To be sealed by the unit incharge of the conclusion, arrangement, drafting of the Standards of theProducts to be registered commissioned by the Manufacturer.  And in the certificate of commission, itshall be clearly indicated that “the ××× Unit is commissioned to be responsiblefor 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”.

4.1.2 The Definition of the LegalRepresentativein accordance with the international   practices, " the signature and seal ofthe Legal Representative of the Manufacturer abroad may be signed and sealed by the  senior official in charge of  the corresponding business activities.

4.2 The Standards of the Products to beRegistered reviewed, codified, and recorded by SDA Standard and TechnicalCommittee;

4.3 As for the Products with nationalstandard and industrial standards, the manufacturer shall, with theimplementation of the standards mentioned above, based on its own specialties,supplement and add corresponding requirements, formulate the Standards of theProducts to be Registeredand assure the safety and effectiveness of the operation of theProducts; if the enterprise thinks that no requirements on safety need to beadded, and that the direct adoption of national standard and industrialstandards as the manufacturer Standards of the Products to be Registered issufficient for the assurance of the safety and effectiveness of the products,the manufacturer shall submit a statement justifying that without any increaseand improvement in the standard index on the basis of national standard andindustrial standards, the safety and effectiveness of the products forapplication can be assured, declaring to bear the quality liabilities after thelaunching of the products and carrying the model, specification of theProducts. As for the products with ISO or IEC standards, the manufacturer shallconvert the standards to the Standards for the Products to be Registered.

5. Operation Manual of the Products

5.1 The methods for the implementation of“Only the Original of the Operation Manual Sealed or Signed by the LegalRepresentative may be submitted”:

(1) The Operation Manual of theProducts of Class II or Class III shall be sealed by the Manufacturer;theOperation manual of the Products of Class I shall not be sealed.

(2)The Definition of the LegalRepresentativein accordance with the international practices, " the signatureand seal of the Legal Representative of the Manufacturerabroad may be signed and sealed by the person in charge of the correspondingbusiness activities.

5.2 Implementation of the “AdministrativeProvisions on the Operation Manual of Medical Devices”. The operation manual ofmedical devices shall implement the national standards provided in “OperationManual for Industrial Products--General provisions”. In accordance with thespecialty 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 theproducts;

(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 graphicexpression of the Installation and Operation;

(7)    The Maintenance methods,special storage methods and length of life of the Products;

(8)    Other necessary contentsspecified in the Product Standards.

6. The Type test Report presented by themedical devices quality test agency recognized by the State Drug Administrationwithin the recent one year (Applied to the Products of Class II and Class III)

6.1 About Test-after-Registration of importproducts

The following import products may apply toTest-after-Registration

(1)    X-Ray Computerized Topography(CT);

(2)    Positron Emission ComputerizedTopography (PET);

(3)    Single Photon Emission ComputerizedTopography (SPECT);

(4)    Extraneous Shock Wave Crusher;

(5)    Color Ultrasonic DiagnosticScanner;

(6)    Large Laser Therapy Apparatus;

(7)    Large X-Ray DiagnosticEquipment;

(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 importproductsthe Manufacturer shall submit an application for the Test and thatthe Products shall commit to complete the Test at first, as the product getsinto the Chinese market. If the product fails to pass the following test, theregistration certificate shall be cancelled by the original issuing agency.

6.2 About the Scope of Acceptance forExamination of the Examination Center

The test on placing the Products under thecompetent unit shall be determined in accordance with the “government certifiedScope of Acceptance for Examination of the Examination Center”. The enterprisemay at its option select one among the qualified examination centers. In caseof any ambiguity on the catalog of the Scope of Acceptance for Examination ofthe Examination Center, a written report shall be submitted to the office ofacceptance, and the office will deliver the case to the competent department todesignate one center for test.

6.3 Under the following Circumstances, notest is required

(1) Among the laboratory equipment,the electrophoresis apparatuscentrifugeUltra Low temperature refrigeratorparaffin slicingmachineparaffin embedding machine, cell centrifuge smearing machine, andfull automatic dying machine  no clinicaltrial reports and Product Type Test Reports issued by the medical devicesquality test agency and recognized by the State Drug Administration arerequired to be provided .

(2)The Products of Class I inaccordance with catalog of classification of the medical devices Products ofChina.

6.4 As for the medical devices inconformance with both of the following conditions the application for exemptionfrom test may be made

(1)The domestic enterprise hasreceived the authentication certificate of GB/T19001+YY/T0287 orGB/T19002+YY/T0288 issued by the quality system authentication agencyrecognized by the State Drug Administration, and the quality system concernedhas covered the Products for application.

The Products abroad has received theauthorization of launching from the competent department of the Country ofOrigin, and the certificate is still valid, and the enterprise has beenauthenticated in accordance with the ISO 9000 Serial Standards (or equivalent).

(2) The difference between thestructure and performance of the Products for application and those of theregistered products of a kind is insignificant in terms of safety andeffectiveness.

(3)The Products for applicationare not implantable device.

(4)No radioactive sources exist inthe Products for application.

(5) In case of any malfunctionno graveinjury accidents such as death of and body injury of the user or operator willbe caused.

7. The clinical trial report of medicaldevices, the methods on the provisions of the report should be applied inaccordance with the “Provisions for the ‘Sub item of Clinical Reports’ for theRegistration of Medical Devices”. The clinical trial shall be implemented inaccordance with the “Provisions for the Clinical Trial Management of MedicalDevices”.

7.1 Prior to the promulgation of the newClinical Trial Management Methods, the quantity and trial period of theClinical Trial shall be implemented in accordance with the “Interim Provisionsfor the Clinical Verifications of Medical Devices” issued by the State DrugAdministration in 1997.

If in accordance with the requirements forsub-item concerned, the provisions for Clinical Reports are not necessary, theenterprise may make a statement upon the application.

7.2 Clinical Reports of Import Products inthe Country of Origin may be provided through the following two methods

(1) In case that clinical reportsare required to submit upon the authorization of launching by the Country ofOrigin, the clinical reports upon the authorization of launching by the Countryof Origin shall be provided;

(2)in case that no clinicalreports are required to submit upon the authorization of launching by theCountry of Origin, the Manufacturer shall make a statement that no clinicalreports are required to submit upon the authorization of launching by the Countryof Originand guarantee the authenticity thereof. In the event, the enterprisemay submit the Clinical Trial Reports and documents after the launching of theProducts.

7.3 Under the following Circumstances, noclinical reports are required.

(1)    In accordance with the cleardivision of work in the State Drug Administration, Among the IVD reagentapproved and registered by Department of Medical Devicesin case ofthose for the diagnosis of hepatitis and AIDS, the Clinical Trials shall becarried out in designated medical institutions (quantity and statisticalmethods undetermined); as for other types of IVD reagent, generally no ClinicalReports are required to be provided.

(2)    As for condom Products, noClinical Reports are required to be provided.

(3)    Among the laboratory equipment,the electrophoresis apparatuscentrifugeUltra Low temperature refrigeratorparaffin slicingmachineparaffin embedding machine, cell centrifuge smearing machine, andfull automatic dying machine no clinical trial reports and Product Type TestReports  issued by the medical devicesquality test agency and recognized by the State Drug Administration arerequired to be provided.

(4)    The Products of Class I inaccordance with the catalog of classification of the medical devices Productsof China.

8. The Product Quality Guarantypresented by the Manufacturer, to promise that the quality of the productsregistered and sold in China are unanimously the same as that of the identicalproducts put into market in the Country (Region) of Origin.

9. The certificate of commission for theAfter-Sale Service Agency designated in China, the letter of commitment andbusiness certificate of the commissioned agency.

9.1 Certificate of commission of After-SaleServices

(1) Presented by the Manufacturer;

(2) The name of the Products shall be indicated clearly in thecertificate of commission;

(3) In case ofmultilevel commissioning, the consignor at every level shall provide thecertified documents of the Manufacturer.

9.2 The letter of commitment

(1) Thecontents promised in the letter of commitment shall be consistent with thematters consigned in the certificate of commission;

(2) The letter of commitment shall alsocontain

   a. Liabilities for reporting the Product quality accidents;

   b. Liabilitiesfor actively contacting with the State competent department in charge of theregistration of medical devices;

9.3 The qualification certificate ofafter-sale service units

Business certificatethe scope ofbusiness shall contain corresponding technical service itemsor theregistration certificate of the representative agency in China of themanufacture.

10. The Self-Guarantee Declaration onthe authenticity of the materials submitted.

"The Self-Guarantee Declaration on theauthenticity of the materials submitted” shall be presented by themanufacturer.

(1) Presented by the manufacturer or the office thereof in China;

(2) A list of the materials submitted;

(3) Commitment on the Liabilities.