第二类医疗器械注册申报资料形式要求（Second types of medical equipment registration declaration form requirements）

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1、第二类医疗器械注册申报资料形式要求（Second types of medical equipment registration declaration form requirements）Second types of medical equipment registration declaration form requirementsI. When an enterprise submits written materials for registration, it shall simultaneously make an electronic declaration. Electro

2、nic reporting procedures and requirements, please login provincial government website download equipment production credit operation manual ( :/ zjfda.gov /download/index.jsp). When accepting the written registration application submitted by the enterprise, the recipient shall accept it online at th

3、e same time.Two, corporate filings in the registration (including the first registration, re registration, to change the standard request and the specification for the record), electronic text should be submitted at the same time the product registration standard and specification (Word format), its

4、 content must be in agreement with the paper. Direct adoption of national standards or industry standards as a product registration standard, may not submit the product registration standard electronic text. When submitting the application for the first registration of medical devices, the enterpris

5、e shall provide the registration verification report together.Three, the application of materials in the same project should be completed in accordance with. Application materials should be printed in A4 specification paper, and documents issued by government and other organizations shall be provide

6、d in the original (copy) size. The application materials shall be clear and neat, each application materials shall be affixed with the seal, and unified with the pumping rod clip in accordance with the order of binding application materials, the data should be separated by every page with the label,

7、 and indicate the data item number. The application for registration shall be made in two originals, one of which is original.For the product structure is complex, the use mechanism is not clear, and the first listing of products in the province to request the application materials in five copies.Ba

8、sic requirements for registration and declaration of second types of medical devicesI. Basic requirements for the first registration of declaration materials(1) application form for registration of medical device products (see Schedule 1, fill out and print from the administrative examination and ap

9、proval system, see the following picture in format)The application form shall be signed by the legal representative and stamped with the official seal. The items to be filled out shall be complete and accurate, and the contents shall be in accordance with the following requirements:1, production ent

10、erprise name, registered address and industrial and commercial business license is exactly the same.2, product name, specification model and the submitted product standards, inspection reports and other application materials used in the name, specification, model is exactly the same.(two) medical eq

11、uipment manufacturing enterprise qualification certificate;Including copies of the copy of the medical device manufacturing enterprise license and copies of the business license. Applications for registration of products shall be within the scope of production approved by the medical device manufact

12、uring enterprise license. The medical device manufacturing enterprise license and the industrial and commercial business license are all in the period of validity.(three) product technical report;The product technical report shall contain at least the following:1, product features, working principle

13、, structure, and intended use;2, technical indicators or main performance indicators to determine the basis;3, product design control, development, development process;4, the main process and description of the product;5, product testing and clinical trials;6, compared with similar products at home

14、and abroad.(four) safety risk analysis reportSafety risk analysis report shall at least include energy hazards, biological hazards, environmental hazards, hazards related to the use of and by failure, maintenance weeks or aging hazard analysis, and other aspects of the risk caused by the risk contro

15、l and prevention measures etc.(five) the implementation of standard products and preparation instructions (except for registration two registered product standards in the data, the other must submit a separate registration standard text for review, and the accompanying medical register standardcheck

16、 questionnaires three copies)The standard form of the product submitted by the enterprise can be divided into three kinds: the national standard, the industry standard or the registered product standard text.1, the national standards and industry standards for product standards, should be effective

17、and practical text submitted to the national standards or industry standards adopted by the instructions, and bear the responsibility for the quality of products listed and related product models, specifications.2. If the registered product standards are used as the product standards, the official t

18、ext of the registered product standards shall be submitted and the compilation instructions shall be submitted. The standard text should be in accordance with the medical device standards on the implementation of management measures , medical standard management procedures related matters notice, me

19、dical device registration standard specification, the requirements of GB/T1.1 system. Prepare registration standard description should include the following contents: (1) the body in contact with the materials have been used in clinic, its safety and reliability are demonstrated to be effective; (2)

20、 the relevant standards or reference data and references;(3) the basis for determining the category of product management; (4) description of the product and the description of the main technical indicators; (5) other content to be explained.(six) product performance self test report;The self-test i

21、tems in the product performance report are the factory inspection items stipulated in the product standard. The product performance report shall include at least the following:1, product name, specification, model, product number or batch number, date of production, sample number, samplingCardinal n

22、umber;2, inspection basis, inspection items, standards requirements, test results, results determine; inspection personnel,Signature or seal of inspection personnel, date of inspection, etc.;3, such as Department of commissioning inspection, should be provided by the entrusted testing institutions i

23、ssued by the inspection report and related agreements.(seven) the product registration test report issued by the medical device testing institution (one original of the request);1, the registration test report shall be issued by the State Food and Drug Administration and the State Administration of

24、Quality Supervision approved by the medical device quality testing institutions, and its products or items tested within the approved statutory testing range;Medical devices 2, clinical trials are necessary, should be submitted to the trial test report issued within the first half of the year; medic

25、al devices do not need for clinical trials, shall submit registration acceptance inspection report types of typical products of the year before the issue;3, if the enterprise according to the management measures medical device registration thirteenth (Registration exemption from registration testing

26、) shall apply for exemption from registration inspection, enterprises should submit official documents and specify the grounds for exemption from inspection.4, if the enterprise involves the supplementary registration test, the validity of the registration inspection report shall be supplemented by

27、the last time, and the registration report shall be valid for the time being.(eight) clinical trial data of two or more clinical trial bases (one original)1, clinical trials of medical instruments, clinical trials should include at least: clinical trial contracts (or agreements), clinical trial prog

28、ram, clinical trial report, and meet the following requirements:(1) medical institutions that carry out clinical trials shall be in the catalogue of published clinical trials bases;(2) the contents in the clinical trial data and the relevant signatures and seals should be complete, standardized and

29、clear;(3) the front page of the clinical program should be consistent with the contents of the home page of the clinical trial report.(4) the product name and model of the clinical trial shall be consistent with the name and type of the test report. Clinical trials should be consistent with the inte

30、nded purpose or scope of the product.(5) clinical programs and clinical trials report with clinical trial institution qifengzhang.2 medical device, clinical trial data submitted to similar products, clinical trial data should include: the enterprises or other enterprises have been listed on the repo

31、rts of clinical trials of similar products or related clinical documents (at least two or more), and compared with similar products (including at least the basic principle, main function, structure, main technical materials the performance index, the intended use of the content, comparing data shoul

32、d also be registered certificate and accessories including the ratio of products).Clinical literature refers to the academic papers, monographs and literature review published by the core medical journals above the provincial level, which can fully illustrate the expected clinical effects of the pro

33、ducts. Requirements related to clinical documentation of similar products:(1) under normal circumstances, according to the content of the literature should be able to determine the product name and use, and declared products registered basically the same.(2) for the treatment of products, if the exi

34、sting similar products approved, it may not require the manufacturer of the product by means of literature in comparison must be registered, the production of similar products in enterprises; if similar products are not approved by the manufacturer of the product is required for documents the compar

35、ison must indicate the registered similar products production enterprises.(3) medical instruments that do not need to provide clinical test data shall comply with the corresponding requirements of the measures for the administration of medical device registration or other normative documents.(nine)

36、the product manual (with seal)Should comply with the medical device products manual, label and packaging logo management regulations requirements. Shall include at least the following:1, product name, model, specifications;2, production enterprise name, registered address, production address, contac

37、t information;3, medical device manufacturing enterprise license number, medical device registration card number (declaration content temporarily)Product standard number;4, product performance, main structure, scope of application.(ten) valid certificate of enterprise quality system examination (cer

38、tification) (original one),For example, if a company makes a declaration of multiple products at the same time, it may indicate the original registration data and only provide photocopiesThe effective certificate of product quality system inspection (certification) shall be one of the following form

39、s of quality system examination report or certificate of authentication:1, the Provincial Bureau signed and within the validity period of the system assessment report, assessment of the product range should cover the application for registration of the product; (submit information including enterpri

40、se quality evaluation system for the application, the Provincial Bureau confirmed that the self inspection form and field inspection report)2, medical equipment production quality management inspection report or medical device quality system certification,Inspection or certification of the product r

41、ange shall cover the application for registration of the product. (it must be the certificate of quality system certification issued by the certification body of the medical device quality system in the YY/T0287-2003 version of the industry standard)Two, second kinds of medical equipment re registra

42、tion, declaration of basic requirements(1) application form for registration of medical device products (registration with registration of quasi products)(two) qualification certificate of medical device manufacturing enterprise (registration with quasi product);(three) a copy of the original regist

43、ration form and the registration form(four) product registration and testing report issued by medical device testing institution. (registration with prospective producer)In accordance with the provisions of the fourteenth measures for registration of Medical Devices Registration (re registration, ex

44、emption from registration examination), the enterprise shall submit an explanatory document for exemption testing.(five) product standards and revisions (requirements, registration of quasi products)The revised specification shall specify all or part of the other documents which are replaced or abol

45、ished by the standard, indicating major technical changes compared to the standard version; and indicating the relationship between the standards and other standards or documents.(six) product quality tracking report;The product quality tracking report shall include the following:1, enterprise quali

46、ty control measures and internal audits of product quality review instructions;2, in the process of product use, the users feedback on the quality of the product;3, product inspection, factory inspection in the daily cycle of product quality; above the provincial food and drug supervision and manage

47、ment departments of product quality supervision and inspection;4, the implementation of adverse events monitoring system and adverse events monitoring;5, information collected by the enterprise on product quality, statistical analysis and the measures taken and the verification.6, for a category of

48、re registration for the two category, the need to provide more than two medical institutions issued on the product after the listing of clinical use summary.(seven) product manual (registration with quasi product).(eight) effective certificate of production quality system examination (certification)

49、 (registration with quasi product).Note: if re registration of products, product standards and specifications have not changed, the enterprise submitted no change statement, no longer submit the registered product standards, registration inspection reports and instructions. For the re registration o

50、f products, product standards or specifications, the enterprise shall submit the relevant registration materials in addition to the registration materials,You should also submit a product or product standard or statement of changes before and after changes, and the corresponding supporting informati

51、on.Three, second kinds of medical equipment registration certificate change or lost documents, fill out the declaration data requirementsThe medical equipment registration certificate change / reissue application form (see Schedule 2, fill in the administrative examination and approval system, see t

52、he chart below), and provide the relevant materials as required by the form.Schedule 1Acceptance number:Accepted date:Zhejiang ProvinceMedical equipment registration formProduct name:Model and specification:Name of manufacturing enterprise:Zhejiang food and Drug AdministrationFill in the directions1

53、. in accordance with the medical device registration and the territory of first, second types of medical equipment registration and approval of operating norms, in vitro diagnostic reagent registration (Trial) submit data and related documents, and mark the tick in the attached data behind the box.

54、The submitted information should be according to the provisions of the order form, and bound. At the same time, each declaration material shall be marked with name and order number.2. this application form should be typed. Fill in the content should be complete, clear, neat, and must not be altered.

55、ThreeThe product name, specification and model shall be in accordance with the name, specification and model of the registered product standards and test reports.4. in case of any material requiring special explanation, please specify in the column other issues that need to be noted in this table5.

56、in the application for registration shall be attached to data and order the corresponding column box have left the project. If in accordance with the relevant provisions of a material is not required to submit, please mark # in the left side of the box, and specify the reason in the form of other ex

57、planations column.7. this application form can be downloaded and printed from the medical device registration approval system.This column is filled out by the registration clerkProduct categoryClass I.Class II.Registration formTo register for the first time.Re registration.The following column is fi

58、lled out by the applicantProduct nameTrade nameModel and specification (packing specification)In vitro diagnostic reagents fill in packing specificationsRegistration formTo register for the first time - re registration.Product categoryClass I - II.Original productRegistration numberFill in again whe

59、n you sign upProduct standardProduct performance, structure and composition (main components)In vitro diagnostic reagents fill out the main componentsScope of application (intended use)In vitro diagnostic reagent for intended useProduct contraindication (product validity)In vitro diagnostic reagents

60、 fill in product expiration dateName of manufacturing enterpriselicense keyProduction addressEnterprise registration addressContactspositionTelephoneFaxRegistration application shall be accompanied by materials and orderNote: Please tick in the box on the left side of the corresponding project. If i

61、n accordance with the relevant provisions of a material is not required to submit, please # in the project on the left side of the box, and specify the reason in the form of other explanations column.Class I.First registrationRe registrationProof - 1. medical equipment production enterprise qualific

62、ation- 2. applicable product standard and instructionsFull performance test report - 3. productsThe production of products - 4. enterprise resources and quality management ability (including detection means) that- 5. manuals of medical devicesProof - 1. medical equipment production enterprise qualif

63、ication- 2, the original medical device registration certificate- 3. applicable product standard and instructions- 4. product quality tracking report- 5. manuals of medical devicesClass II.First registrationRe registrationProof - 1. medical equipment production enterprise qualification- 2. Technical

64、 Report- 3. security risk analysis report- 4. applicable product standard and instructions- 5. self testing product performance reportProduct testing report issued by - 6. medical device testing institutions- 7. medical clinical trial data- 8. manuals of medical devicesEvaluation of the production quality system (product certification) - 9. valid certificatesProof - 1. medical equipm