Laws & Regulations/
Measures for the Administration of Medical Device Registration (No.16)


The Measures forthe Administration of Medical Device Registration were passed by State Food andDrug Administration at the administration affairs meeting on May 28, 2004 andare hereby promulgated for implementation as of the date of promulgation.

Director general: Zheng Xiaoyu

Aug.9, 2004


Measures for the Administration of Medical Device Registration

Chapter 1. General Provisions

Article 1

These Measures are formulated in accordance with the Regulations on the Supervisionand Administration of Medical Devices to standardize the administration ofmedical device registration and guarantee the safety and effectiveness ofmedical devices.

Article 2

All the medical devices sold and used within the territory of the People's Republic of China shall be subject to application for registration in accordance with the provisions of these Measures. The medical devices whose registration fails to be approved shall not be sold or used.

Article 3

Medical device registration means the process of systematic evaluation of the safety and effectiveness of the medical devices to be sold and used in accordance withthe legal procedures to decide whether the sale and use of such medical devicescan be approved.

Article 4

China implements classified registration and administration of medical devices.

Category I domestic medical devices are subject to examination by municipal level (food) drug administration authorities of the administrative areas with districts, and medical device registration certificates will be issued after approval by such authorities.

Category II domestic medical devices are subject to examination by the (food) drugadministration authorities of provinces, autonomous regions and municipalities,and medical device registration certificates will be issued after approval bysuch authorities.

Category III domestic medical devices are subject to examination by the State Food andDrug Administration (SFDA), and medical device registration certificates willbe issued after approval by SFDA.

Foreignmedical devices are subject to examination by SFDA, and medical deviceregistration certificates will be issued after approval by SFDA.

Unlessotherwise specified hereunder, medical devices from Taiwan, Hong Kong and Macaoshall be registered by reference to the measures for the registration offoreign medical devices.

Thevalid period of each medical device registration certificate shall be fouryears.

Article5

Medicaldevice registration certificates shall be printed by SFDA in a centralized way,while the corresponding contents shall be completed by the (food) drugadministration authorities responsible for examination and registration.

Registrationnumbers shall be arranged in the following form:

×(×)1(S)YJX(×2)Z××××3No. ×4××5××××6, where,

×1shall mean the abbreviation of the place where the registration examination andapproval authority is located:

Theletter “G” shall be adopted for Category III domestic medical devices, foreignmedical devices and medical devices from Taiwan, Hong Kong and Macao;

Theabbreviation of the province, autonomous region or municipality where theregistration examination and approval authority is located shall be adopted forCategory II medical devices;

Theabbreviation of the province, autonomous region or municipality where the registrationexamination and approval authority is located plus the abbreviation of thelocal municipal level administrative area with districts shall be adopted inthe form of ××1 for Category I domestic medical devices (only the abbreviationsof the local province, autonomous region or municipality shall be adopted ifthere is no corresponding municipal level administrative area with districts);

×2shall indicate the form of registration (Z [approval], J [import] and X[permit]):

“Z”is applicable to domestic medical devices;

“J”is applicable to foreign medical devices;

“X”is applicable to medical devices from Taiwan, Hong Kong and Macao;

××××3shall indicate the year of approval for registration;

×4shall indicate the category of product administration;

××5shall indicate the type code of product; and

××××6shall indicate the serial number of registration.

Themedical device registration record (see Appendix 1 of these Measures) attachedto each medical device registration certificate shall be used together with themedical device registration certificate.

Article6

Amanufacturer applying for medical device registration shall undertake thecorresponding legal obligations and hold a medical device registrationcertificate after the application is approved.

Theperson handling the matters related to application for medical deviceregistration shall be subject to authorization by the manufacturer, have thecorresponding professional knowledge and be familiar with the laws, rules,regulations and technical requirements on the administration of medical deviceregistration.

Regardingapplication for the registration of foreign medical devices, the foreignmanufacturer shall designate an organization located within the territory ofChina to act as the foreign manufacturer’s agent, who shall undertake thecorresponding legal liability. The foreign manufacturer shall also entrust acorporate organization that is located within the territory of China and hasthe corresponding qualifications or entrust the manufacturer’s organ in Chinato undertake after-sale service for the medical devices.  

Article7

Themedical device under application for registration shall have an applicableproduct standard, which may adopt a national standard, a professional standardor a registered product standard formulated by the manufacturer, but theregistered product standard shall not be inferior to the relevant nationalstandard or professional standard.

Registeredproduct standards shall be formulated in accordance with the requirements ofSFDA for the administration of the standards of medical devices.

Article8

Whena manufacturer applies for the registration of a Category II or III medicaldevice, the manufacturer shall satisfy the production conditions specified bySFDA or meet the requirements of the relevant quality system.

Chapter 2. Test for Medical Device Registration

Article9

CategoriesII and III medical devices are subject to registration test by the medicaldevice test organizations recognized by SFDA and the General Administration ofQuality Supervision, Inspection and Quarantine. Such medical devices shall beproved conforming to the applicable product standards through test before themedical devices are used for clinical trial or an application is submitted forregistration.

Thelist of the medical device test organizations recognized by SFDA and theGeneral Administration of Quality Supervision, Inspection and Quarantine(hereinafter referred to “medical device test organizations”) will beseparately announced.

Article10

Themedical device test organizations shall conduct registration test to theproposed products and issue test reports within the scope of test approved bySFDA and the General Administration of Quality Supervision, Inspection andQuarantine and in accordance with the product standards proposed by themanufacturers (including the applicable national standards, professionalstandards or the registered product standards formulated by the manufacturers).

Forthe medical devices that have not been included in the authorized scope of testby the medical device test organizations, the corresponding registrationexamination and approval authority shall designate a test organization with thenecessary test capacity to test such medical devices.

Theregistration test of foreign medical devices shall be conducted in accordancewith the Regulations on the Registration Test of Foreign Medical Devices.

Article11

Thetested products in a same registration unit shall be typical products that canrepresent the safety and effectiveness of the other products in thisregistration unit.

Article12

Thesimilar products manufactured by a same manufacturer with the same rawmaterials may not be subject to biological compatibility test during thebiological evaluation of the products for re-registration, provided that theproduction technology and the expected purpose of the products remainunchanged.

Thesimilar products manufactured by a same manufacturer with raw materials thathave passed biological evaluation may not be subject to biologicalcompatibility test during the biological evaluation of the products forregistration, provided that the production technology and the expected purposeof the products remain unchanged or there are no new potential biologicalrisks.

Article13

Applicationfor the registration of a Category II or III medical device may be exemptedfrom registration test if this medical device can satisfy all the followingconditions:

(1)     Thebasic principle, main function, structure, material, material quality andexpected purpose of the medical device under application for registration aresame as those of the manufacturer’s medical device that has already beenapproved for registration;

(2)     Themanufacturer has passed the examination of quality management standard formedical device manufacturing or has passed the certification of quality systemfor medical devices, and the manufacturer can provide a test report recognizedby the original production condition examination authority;

(3)     Themedical device under application for registration has seen no changes relatedto safety and effectiveness as compared with the manufacturer’s similar productthat has already been approved for registration and has passed registrationtest, or though there are changes related to safety and effectiveness, thechanged parts and the other parts of the product with subsequent changesrelated to safety and effectiveness have passed test by a medical device testorganization;

(4)     Themanufacturer’s similar product that has already been approved for registrationhas seen no adverse events during the monitoring of the adverse events ofmedical devices in accordance with the relevant regulations;

(5)     Themanufacturer’s similar product that has already been approved for registrationhas no record of nonconformities as determined by the (food) drugadministration authority during selective examination for product qualitysupervision within one year; and

(6)     Ifthe medical device under application is a foreign medical device, the sale ofthe medical device has been approved by the medical device administrationauthority of the relevant foreign government.

Article14

Applicationfor the re-registration of a Category II or III medical device may be exemptedfrom registration test if this medical device can satisfy all the followingconditions:

(1)   Thebasic principle, main function, structure, material, material quality andexpected purpose of the medical device under application for registration aresame as those of the manufacturer’s medical device that has already beenapproved for registration;

(2)   Themanufacturer has passed the examination of quality management standard formedical device manufacturing or has passed the certification of quality systemfor medical devices, and the manufacturer can provide a test report recognizedby the original production condition examination authority;

(3)   Themedical device under application for re-registration has seen no changesrelated to safety and effectiveness as compared with the originally registeredproduct that has passed registration test, or though there are changes relatedto safety and effectiveness, the changed parts and the other parts of theproduct with subsequent changes related to safety and effectiveness have passedtest by a medical device test organization;

(4)   Themedical device under application for re-registration has seen no adverse eventsduring the monitoring of the adverse events of medical devices in accordancewith the relevant regulations within the valid period of the original medicaldevice registration certificate; and

(5)   Theoriginally registered medical device has no record of nonconformities asdetermined by the (food) drug administration authority during selectiveexamination for product quality supervision within one year.

Article15

Anapplication for the postponement of test may be submitted for large medicaldevices that have obtained sales approval from the medical deviceadministration authority of the relevant foreign government, have specialrequirements for the site of installation and are difficult to be tested, andsupplementary test shall be conducted for such medical devices after a medicaldevice registration certificate is obtained.

Fora product that is under application for the postponement of test and has beenapproved for registration in accordance with the provision of the aboveparagraph, the manufacturer must complete registration test after the firstmedical device is imported and before the medical device is put into use. Themedical device shall not be used until the end of satisfactory test.

Chapter 3. Clinical Trial of Medical Devices

Article16

Clinicaltrial documents shall be submitted for application for the registration ofCategories II and III medical devices.

Clinicaltrial documents shall be submitted in the manner specified in the ClassifiedRegulations on Clinical Trial Documents for Medical Device Registration (seeAppendix 12 of these Measures).

Article17

TheRegulations on the Clinical Trial of Medical Devices shall be strictly followedfor the medical devices whose clinical trial is conducted within the territoryof China.

Article18

Theclinical trial documents for a medical device whose clinical trial is conductedwithin the territory of China shall include a contract for clinical trial, aplan of clinical trial and a report of clinical trial.

Whenit’s necessary at the (food) drug administration authority’s discretion, the(food) drug administration authority may ask the manufacturer to submit theinstructions on clinical trial, the letter of consent to clinical trial and theoriginal record of clinical trial.

Chapter 4. Application for and Examination andApproval of

Medical Device Registration

Article19

Toapply for medical device registration, the applicant shall, according to theclassification of medical devices, submit an application to the corresponding(food) drug administration authority in accordance with the provisions ofArticle 4 of these Measures. The applicant shall complete a written applicationfor medical device registration and submit application documents in accordancewith the corresponding requirements of Appendix 2, 3, 6, 8 or 9 of theseMeasures. The application documents shall be made in Chinese; and theapplication documents translated on the basis of foreign documents shall beaccompanied by the original documents.

Themanual of medical device submitted by the applicant shall conform to theRegulations on the Administration of the Manuals, Labels and Packing Marks ofMedical Devices.

Theapplicant shall be responsible for the truthfulness of all the contents of theapplication documents submitted by it.

Article20

Aftera (food) drug administration authority receives an application, this authorityshall dispose of the application respectively according to the followingcircumstances:

(1)      Ifthe matter under application is beyond the limits of the (food) drugadministration authority’s functions and powers, the (food) drug administrationauthority shall immediately decide to reject the application and notify theapplicant to apply to the relevant administration authority;

(2)      Ifthe application documents have mistakes that can be corrected on the spot, the(food) drug administration authority shall allow the applicant to correct themistakes on the spot;

(3)      Ifthe application documents are incomplete or do not meet the requirements offormal examination, the (food) drug administration authority shall issue anotice for the supplementation or correction of documents to the applicant onthe spot or within five working days to inform the applicant of all thecontents that need to be supplemented or corrected once and for all; theapplication documents shall be deemed to have been accepted from the date ofreceipt if the (food) drug administration authority fails to inform theapplicant of the contents that need supplementation or correction within thetime limit; or

(4)      The(food) drug administration authority shall accept the application documents ifthe application documents are complete and meet the requirements of formalexamination or the applicant has submitted all the necessary supplementary orcorrective documents in accordance with the requirements.

Afteraccepting or rejecting an application for medical device registration, the(food) drug administration authority shall issue a notice of acceptance or anotice of rejection that is affixed with the (food) drug administrationauthority’s special seal and dated.

Article21

Aftera (food) drug administration authority accepts an application for medicaldevice registration, the (food) drug administration authority shall conductsubstantive examination of the application and make a written decision onwhether to register the medical device under application for medical deviceregistration. If the application is proved conforming to the regulationsthrough examination and registration is approved, the (food) drugadministration authority shall issue a medical device registration certificateto the applicant within 10 working days after the written decision of approvalis made. If the application is proved nonconforming to the regulations, the(food) drug administration authority shall make a written decision of noregistration, indicate the reason and inform the applicant of its right toapply for administrative reconsideration or bring an administrative lawsuitaccording to law.

Article22

Themunicipal level (food) drug administration authority of an administrative areawith districts shall decide to approve registration or not within 30 workingdays after accepting an application.

The(food) drug administration authority of a province, autonomous region ormunicipality shall decide whether to approve registration or not within 60working days after accepting an application.

SFDAshall decide whether to approve registration or not within 90 working days afteraccepting an application.

Iftest, expert evaluation or hearing is needed during the examination of anapplication for registration, the period of test, expert evaluation or hearingshall not be included in the time limit specified in this Article. The (food)drug administration authority shall notify the applicant of the said periodneeded by writing.

Article23

Applicationfor the registration of a foreign medical device that has obtained no foreignsales license for medical devices shall be examined in accordance with therequirements of technical examination for the registration of similar domesticproducts (See Appendixes 8 and 9 of these Measures for the documents that needto be submitted).

Article24

Duringthe technical examination of application documents for medical deviceregistration, if the (food) drug administration authority finds that themanufacturer needs to supplement documents, the (food) drug administrationauthority shall issue a notice for the supplementation of documents once andfor all.

Themanufacturer shall fully supplement the necessary documents once and for allwithin 60 working days in accordance with the requirements of the notice. Theperiod used for supplementing materials shall not be included in the time limitfor substantive examination by the (food) drug administration authority. Theexamination shall be terminated if the manufacturer fails to submitsupplementary documents within the specified time limit without justifiedreasons.

Article25

Incase the examination of application for registration is terminated, themanufacturer shall put forth no new application within six months after thetermination.

Article26

Ifthe manufacturer has any objection to the content of the notice forsupplementing documents, the manufacturer may put forth its written opinions tothe (food) drug administration authority within the specified time limit,indicate the reason of objection and provide technical support documents. The(food) drug administration authority shall make a decision after examining thedocuments submitted by the manufacturer.

Article27

Theregistration units of medical devices shall be divided according to technicalstructures, performance indexes and expected purposes in principle.

Article28

Fora medical device that is registered as a component, the applicant shallindicate the name, model and specifications of the product or componentrecommended for use together with the medical device.

Theprocedures of complete device registration must be gone through for a completedevice that is composed of components that have been approved for registration.

Fora medical device that is registered as a complete device, a list of its majorcomponents shall be provided during application for registration. The completedevice shall be registered anew after the performance and specifications of amajor component are changed.

Amedical device that is registered as a complete device may be exempted fromseparate registration provided that the medical device’s components set forthin the column “Performance, Structure and Components of the Product” in theattached table of the registration certificate for the medical device can beseparately sold on the condition of no changes in the form of assembly and theexpected purpose.

Article29

A(food) drug administration authority shall make public the necessaryconditions, procedure and time limit for the corresponding medical deviceregistration, a list of all the documents that need to be submitted and ademonstrative text of application in the administration authority’s website andthe medical device registration office.

Article30

A(food) drug administration authority shall make public the process and theresult of examination and approval during the examination of an application formedical device registration. The applicant and the interested party may presenttheir opinions and defend themselves on the matters directly related to theirmajor interests.  

Article31

SFDAshall regularly announce in its website the catalogue of the medical devicesthat have been approved for registration for public consultation.

Article32

Incase an application for medical device registration directly touches upon therelationship of major interests between the applicant and another party, the(food) drug administration authority shall tell the applicant and theinterested party that they have the right to apply for hearing in accordancewith laws, regulations and the other regulations of SFDA; during theexamination of an application for medical device registration, the (food) drugadministration authority shall publicly announce and hold a hearing of themajor licensing matters that touch upon public interests at the (food) drugadministration authority’s discretion.

Chapter 5. Re-registration of Medical Devices

Article33

Ifa manufacturer holding a medical device registration certificate needs tocontinuously sell or use the relevant medical device after the registrationcertificate expires, this manufacturer shall apply for re-registration withinsix months before the valid period of the medical device registrationcertificate expires. If the manufacturer fails to apply for re-registrationwithin the time limit, the product shall be subject to registration test forre-registration.  

Article34

Incase any of the following items in a medical device registration certificate ischanged, the manufacturer shall apply for re-registration of the relevantproduct within 30 days from the date of change:

(1)    Model;

(2)    Addressof manufacturing site;

(3)    Productstandard;

(4)    Performance,structure and components of the product; or

(5)    Indications.

Article35

Ifthe category of product administration is changed within the valid period ofthe medical device registration certificate, the manufacturer shall, accordingto the category after change, apply to the corresponding (food) drugadministration authority for re-registration within six months.

Article36

Toapply for the re-registration of a medical device, the applicant shall completea written application for medical device registration and submit theapplication documents to the (food) drug administration authority in accordancewith the corresponding requirements of Appendix 4, 5 or 7 of these Measures.

Therelevant provisions of Chapter 4 of these Measures shall apply to theprocedures of application acceptance, examination and approval forre-registration if such procedures are not separately specified in thisChapter.

Article37

Amedical device shall not be reregistered in any of the following circumstances:

(1)    Theapplicant fails to meet the requirements specified by the (food) drugadministration authority in accordance with SFDA’s relevant regulations at thetime of approval for sale;

(2)    Themedical device is obsolete as indicated by the result of reevaluation by SFDA;or

(3)    Themedical device registration certificate for the medical device has beencancelled in accordance with the Regulations on the Supervision andAdministration of Medical Devices.

Chapter 6. Modification and Re-issuance of MedicalDevice

Registration Certificate

Article38

Incase the items in a medical device registration certificate see any of thefollowing changes, the manufacturer shall apply for the modification of medicaldevice registration certificate within 30 days after the date of change:

(1)    Changeof the manufacturer’s name but no change of the manufacturer’s entity;

(2)    Changeof the manufacturer’s registered address;

(3)    Literalchange of the address of manufacturing site;

(4)    Literalchange of product name or trade name;

(5)    Literalchange of model or specifications;

(6)    Literalchange of the name or code of product standard;

(7)    Changeof agent; or

(8)    Changeof after-sale service provider.

Article39

Toapply for the modification of a medical device registration certificate, theapplicant shall complete an written application for the modification of medicaldevice registration certificate and submit the relevant documents andexplanations to the original registration examination and approval authority inaccordance with the requirements of Appendix 10 of these Measures. The originalregistration examination and approval authority shall conduct formalexamination of the application documents and inform the applicant of all thecontents that need to be supplemented or corrected once and for all on the spotor within five working days. A notice of acceptance shall be issued to theapplicant if the application documents meet the requirements.

Article40

Theoriginal registration examination and approval authority shall decide bywriting whether to approve the modification or not within 20 working days afteraccepting the application. If the modification is proved conforming to theregulations through examination, the original registration examination andapproval authority shall issue a modified medical device registrationcertificate and nullify the original one. If the modification is provednonconforming to the regulations through examination, the original registrationexamination and approval authority shall decide by writing to reject theapplication for modification, indicate the reason and tell the applicant thatit has the right to apply for administrative reconsideration or bring anadministrative lawsuit according to law.

Themodified medical device registration certificate shall adopt the originalserial number, and the word “Modified” in brackets shall be added at the end ofthe serial number.

Theexpiry date of the modified medical device registration certificate shall besame as that of the original certificate, and the certificate holder shallapply for re-registration upon expiry of the valid period.

Article41

Incase a manufacturer’s medical device registration certificate is lost ordamaged, the manufacturer shall apply to the original registration examinationand approval authority for re-issuance by submitting the relevant documents andexplanations in accordance with the requirements of Appendix 11 of theseMeasures.

Chapter 7. Supervision and Administration

Article42

The(food) drug administration authorities in charge of examination and approvalfor medical device registration shall conduct examination and approval inaccordance with the specified procedures and decide whether to approveregistration or not. Those who approve registration in violation of theregulations shall undertake the relevant administrative liability.

Article43

Incase a local (food) drug administration authority at municipal level or aboveof an administrative area with districts implements medical device registrationin violation of the provisions of these Measures, the (food) drugadministration authority directly superior to the said local (food) drugadministration authority shall order the latter to correct its fault within aparticular time limit. If the local (food) drug administration authority failsto conduct correction within the time limit, the superior (food) drugadministration authority may make a public announcement to directly cancel therelevant medical device registration certificate. The medical device whosemedical device registration certificate has been cancelled shall be notcontinuously sold or used; and the local (food) drug administration authoritiesof county level or above shall be responsible to supervise the manufacturer todispose of the products that have already been sold or used.  

Article44

The(food) drug administration authorities at provincial level or above shallconduct technical reevaluation to the medical devices on the market and,according to the result of technical reevaluation, decide to cancel the medicaldevice registration certificates of the medical devices whose expected purposescannot be reached or whose safety and effectiveness cannot be guaranteed. The(food) drug administration authorities shall publicly announce the medicaldevices whose certificates have been cancelled. The medical devices whosemedical device registration certificate have been registered shall be notcontinuously sold or used; and the local (food) drug administration authoritiesat county level or above shall be responsible to supervise the manufacturers todispose of the products that have already been sold or used.

Article45

Inany of the circumstances specified in Article 70 of the Administrative LicenseLaw of the People’s Republic of China, the original registration examinationand approval authority shall cancel the relevant medical device registrationcertificate according to law.

Chapter 8. Legal Liability

Article46

Ifa manufacturer provides false certification, document or sample in violation ofthe provisions of these Measures during application for medical deviceregistration, or attempts to obtain a medical device registration certificateby such improper means as fraudulence and bribery, the registration examinationand approval authority shall reject this manufacturer’s application or refuseto register this manufacturer’s product and give the manufacturer a warning,and shall not accept this manufacturer’s application for medical deviceregistration within one year; if the manufacturer has already obtained amedical device registration certificate, the registration examination andapproval authority shall cancel the certificate, shall not accept themanufacturer’s application for medical device registration within two years,and shall punish the manufacturer in accordance with the provisions of Article40 of the Regulations on the Supervision and Administration of Medical Devices.

Article47

Ifa manufacturer alters, sells, leases or lends its medical device registrationcertificate or illegally transfers its medical device registration certificatein other forms, the local (food) drug administration authority at county levelor above shall order this manufacturer to correct its fault and concurrentlyimpose on the manufacturer a fine less than RMB 30,000.

Article48

Ifa manufacturer violates the provisions of Article 33, 34 or 35 of theseMeasures by selling medical device before going through the procedures ofmedical device re-registration according to law, or selling medical deviceinconsistent with that specified in the registration certificate, or sellingmedical device whose manual, label and packing mark are inconsistent with thosespecified in the registration certificate, the local (food) drug administrationauthority at county level or above shall punish this manufacturer in accordancewith the penalty provisions of the Regulations on the Supervision andAdministration of Medical Devices for the sale of medical devices withoutregistration certificate.  

Article49

Ifa manufacturer violates the provisions of Article 38 of these Measures byfailing to apply for the modification of its medical device registrationcertificate according to law, the local (food) drug administration authority atcounty level or above shall order this manufacturer to correct its fault withina particular time limit or give this manufacturer a warning; if themanufacturer fails to conduct correction within the time limit, the (food) drugadministration authority may impose upon the manufacturer a fine more thanRMB5,000 but less than RMB10,000.

Article50

Ifthe manufacturer of a product that shall be tested after application forregistration in accordance with Article 15 of these Measures puts the productinto use before registration test is completed in accordance with theregulations, SFDA shall cancel the medical device registration certificate,announce the cancellation and record the matter in the manufacturer’s creditfile.

Ifa product is proved unqualified through registration test, SFDA shall cancelthe medical device registration certificate.

Chapter 9. Supplementary Provisions

Article51

Manufacturersmean the organizations that put their products on the market in their own namesand undertake final legal liability for their products.

Article52

Registeredproducts mean the products that have been approved for registration and theproducts whose manuals, labels and packing marks are consistent with thosespecified in the corresponding medical device registration certificate.

Article53

Allthe medical devices manufactured within the valid period of the correspondingmedical device registration certificate shall be deemed products withcertificates.

Article54

SFDAshall separately formulate the regulations on the administration of theregistration of external diagnosis reagents that are registered andadministered as medical devices.

Article55

SFDAshall be responsible to interpret these Measures.

Article56

TheseMeasures shall be implemented as of the date of promulgation, when the Measureson the Administration of Medical Device Registration promulgated by the StateDrug Administration on Apr. 5, 2000 shall be abolished at the same time.


Appendixes:

1.      Formof Medical Device Registration Record

2.      Requirementson Application Documents for the Registration of Category I Domestic MedicalDevices

3.      Requirementson Application Documents for the Registration of Categories II and III DomesticMedical Devices

4.      Requirementson Application Documents for the Re-registration of Category I Domestic MedicalDevices

5.      Requirementson Application Documents for the Re-registration of Categories II and IIIDomestic Medical Devices

6.      Requirementson Application Documents for the Registration of Foreign Medical Devices

7.      Requirementson Application Documents for the Re-registration of Foreign Medical Devices

8.      Requirementson Application Documents for the First Registration of Category I ForeignMedical Devices without Foreign Sales License for Medical Devices

9.      Requirementson Application Documents for the First Registration of Categories II and IIIForeign Medical Devices without Foreign Sales License for Medical Devices

10.  Requirementson Application Documents for the Modification of Medical Device RegistrationCertificate

11.  Requirementson Application Documents for the Re-issuance of Medical Device RegistrationCertificate

12.  ClassifiedRegulations on Clinical Trial Documents for Medical Device Registration



(Appendixes 1-5, not needtranslation)
Appendix 6:

Requirements onApplication Documents for the Registration of

Foreign MedicalDevices

(1)    Anwritten application for the registration of foreign medical devices

(2)    Qualificationcertificate of the medical device manufacturer

(3)    Duplicateof the applicant’s business license and the manufacturer’s letter ofauthorization for registration by agent

(4)    Certificationdocument evidencing the relevant foreign government’s medical deviceadministration authority’s approval or permit of the sale of the product on themarket of that country (region) as medical device

(5)    Applicableproduct standard

When a national standard or professionalstandard of China is adopted as the applicable standard for the product, thetext of the national standard or professional standard of China shall beprovided; the registered product standard shall be signed and sealed by themanufacturer or its representative office in China or by the standard draftingorganization entrusted by the manufacturer. In the manufacturer’s letter ofauthorization for entrusted standard drafting it shall be clearly indicatedthat “the manufacturer is responsible for product quality”.

The manufacturer shall submit a statement ofits product’s compliance with China’s national standard and professionalstandard, a statement of the manufacturer’s liability for the quality of theproduct after the product is put on the market, and instructions on the classificationof the models and specifications of the product.

In this Appendix, the words “seal and sign”mean sealing by the relevant organization, or signing by its legalrepresentative or person in charge, or signing plus sealing (same as below whenforeign medical devices are mentioned).

(6)    Manualof medical device

The manual of a Category II or III medicaldevice shall be signed and sealed by the manufacturer or its representativeoffice in China; the manual of a Category I medical device may not be sealedand signed.

(7)    Testreport for product registration issued by a medical device test organization(applicab