體外診斷試劑注冊(cè)管理辦法-en(共17頁)

1、精選優(yōu)質(zhì)文檔-傾情為你奉上SFDAState Food and Drug AdministrationCircular on Printing and Issuing the Measures for the Administration of In-vitro Diagnosis Reagents (Interim)Authorized by MD Dept. SFDA 2007 No. 229The appropriate food and drug administrations (drug administrations) in provinces, autonomous region

2、s and municipalities directly under the central government, The Measures for the Administration of In-vitro Diagnosis Reagents (Interim) was approved by the State Food and Drug Administration of the Peoples Republic of China on April 3rd, 2007 and is hereby printed and issued, and shall be observed

3、and implemented accordingly.State Food and Drug AdministrationApril 19, 2007Measures for the Administration of In-vitro Diagnosis Reagents (Interim)Chapter 1 General ProvisionsArticle 1 The Measures for the Administration of In-vitro Diagnosis Reagents (Interim) is formulated in accordance with the

4、Regulations on the Supervision & Administration of Medical Devices and the Measures for the Administration of Medical Device Registration, with a view to regulating the administration of in-vitro diagnosis reagents. Article 2 The Measures applies to the R&D, clinical trials, registration ins

5、pection, product registration and supervision & administration of in-vitro diagnosis reagents. Article 3 The in-vitro diagnosis reagents mentioned in these Measures refer to the in-vitro diagnosis reagents administered as medical devices, including the reagents, reagent cartridges, calibrators,

6、quality controls, etc. for in-vitro inspection of human body specimen (various body fluids, cells, tissue specimen, etc.) in the course of disease prevention, diagnosis, treatment monitoring, prognosis observation, health status evaluation and inherited disease prediction, which can be used independ

7、ently or in combination with instruments, devices, equipment or systems. The in-vitro diagnosis reagents legitimately stipulated by the state for use in blood screening and radionuclide-labeled in-vitro diagnosis reagents do not belong to the administration scope of the Measures. Article 4 Registrat

8、ion of in-vitro diagnosis reagents refers to the approving process in which the authorities of drug supervision and administrations implement a systematic evaluation on the research conducted by the registration applicant as regards the safety, effectiveness and quality controllability of the produc

9、ts to be put on market and its results, and determine whether to approve such application, in accordance with legal procedures and the application of the registration applicant. Article 5 The State implements classified registration administration of in-vitro diagnosis reagents. Class I in-vitro dia

10、gnosis reagents made within territory shall be examined by drug supervision and administration authorities having districts established therein where such authorities reside, and medical device registration certificates shall be issued after approval. Class II in-vitro diagnosis reagents made within

11、 territory shall be examined by authorities of drug supervision and administrations in provinces, autonomous regions and municipalities directly under the central government, and medical device registration certificates shall be issued after approval. Class III in-vitro diagnosis reagents made withi

12、n territory shall be examined by the State Food and Drug Administration, and medical device registration certificates shall be issued after approval. In-vitro diagnosis reagents made abroad shall be examined by the State Food and Drug Administration, and medical device registration certificates shal

13、l be issued after approval. The registration of in-vitro diagnosis reagents manufactured in Taiwan, Hong Kong or Macao shall be carried out with reference to the relevant provisions in connection with foreign medical devices. Article 6 The authorities of drug supervision and administrations in provi

14、nces, autonomous regions and municipalities directly under the central government are responsible for verification of the R&D status and production conditions of the applied products in their own administrative areas, assessment of the quality management system of the manufacturing enterprise, a

15、nd implementation of supervision and administration for the products put on the market. Article 7 The applicant for the registration of in-vitro diagnosis reagents (hereinafter referred to as the “applicant”) refers to any manufacturing enterprise that puts forward the application for the registrati

16、on of in-vitro diagnosis reagents, assumes corresponding legal responsibilities, and holds the registration certificate after such application is approved. Domestic applicants refer to manufacturing enterprises legitimately registered within Chinese territory. Foreign applicants refer to manufacturi

17、ng enterprises legitimately registered outside Chinese territory. Foreign applicants shall carry out the registration of in-vitro diagnosis reagents through their offices located within Chinese territory or by entrusting agencies within Chinese territory. Personnel who handle the issues concerning t

18、he application for the registration of in-vitro diagnosis reagents shall have corresponding professional knowledge, and are familiar with the laws, regulations, rules and technical requirements as regards the registration administration of in-vitro diagnosis reagents. Article 8 Foreign applicants sh

19、all entrust legitimate organizations within Chinese territory as their agencies, and if the foreign applicants have set up offices within Chinese territory, their agents shall be such offices; if the foreign applicants have no office within Chinese territory, they shall entrust other independent leg

20、al entities as their agents. The agents shall perform the following duties: (I) Liaison with competent authorities and foreign applicants for application; (II) Faithful and accurate conveying of relevant regulations and technical requirements to the applicant;(III) Gathering of information about unf

21、avorable incidents related to medical devices after being put on the market and feedback to foreign applicants, and in the meantime reporting to Chinas corresponding medical device supervision and administration departments. Article 9 In case the applicant entrusts a registration agency to handle is

22、sues concerning the registration of in-vitro diagnosis reagents, except for the application for changing the agent or registration agency, other issues of application shall be concretely handled by such registration agency. Article 10 The quality management system of the manufacturing enterprise of

23、in-vitro diagnosis reagents shall comply with the requirements of Detailed Rules for the Implementation of the Production of In-vitro Diagnosis Reagents, and foreign manufacturing enterprise shall also conform to the requirements of quality management system in the country or region of production. A

24、rticle 11 The manufacturing enterprise of in-vitro diagnosis reagents shall have after-sale service ability in technical training, consultancy, etc. that matches its products applying for registration. Foreign manufacturing enterprises can carry out after-sale service in technical training, consulta

25、ncy, etc. through their offices that reside within Chinese territory or by entrusting agencies within Chinese territory. Chapter 2 Product Classification and Naming PrinciplesArticle 12 According to the product risk degree, in-vitro diagnosis reagents are successively classified into Class III, Clas

26、s II and Class I products. (I) Class III products: 1. Reagents related to the inspection of antigen, antibody and nucleic acid, etc. for pathogen; 2. Reagents related to blood group and tissue typing; 3. Reagents related to the inspection of human gene; 4. Reagents related to inherited diseases; 5.

27、Reagents related to the inspection of narcotic drugs, psychotropic drugs and toxic drugs for medical use; 6. Reagents related to the inspection of targets sites of curative drugs; 7. Reagents related to the inspection of tumor markers; 8. Reagents related to allergy (allergen). (II) Class II product

28、s: products not clearly defined as Class III and Class I products are Class II products, mainly including: 1. Reagents used for protein inspection; 2. Reagents used for carbohydrate inspection; 3. Reagents used for hormone inspection; 4. Reagents used for enzymes inspection; 5. Reagents used for est

29、ers inspection; 6. Reagents used for vitamin inspection; 7. Reagents used for inorganic ion inspection; 8. Reagents used for the inspection of drugs and drug metabolites; 9. Reagents used for auto-antibody inspection; 10. Reagents used for microorganism identification and medicine sensitivity experi

30、ment; 11. Reagents used for the inspection of indexes for other physiological, biochemical and immune functions. (III) Class I products: 1. Microorganism culture medium (not used for microorganism identification and medicine sensitivity experiment); 2. Products for specimen treatment, e.g. hemolytic

31、 agents, diluents, staining solutions, etc. Article 13 If the inspection of some Class II products, e.g. protein, carbohydrate, hormone, enzymes, etc. is used for the monitoring of tumor diagnosis, auxiliary diagnosis and treatment process, or used for diagnosis and auxiliary diagnosis, etc. of inhe

32、rited diseases, these products are registered and administered as Class III products. Among the reagents for inspection drugs and drug metabolites, if the drugs belong to the scope of narcotic drugs, psychotropic drugs and toxic drugs for medical use, they are registered and administered as Class II

33、I products. Article 14 For in-vitro diagnosis reagents such as calibrators and quality controls, if not sold independently, the registration neednt be applied for independently; if sold independently, the registration needs to be applied for independently, and their class is the same as those in-vit

34、ro diagnosis reagents in clinical use in the meantime. As for multiple calibrators and quality controls, their class is the same as higher-class in-vitro diagnosis reagents used in the meantime. Article 15 For products only used for research, not used for clinical diagnosis, the registration neednt

35、be applied for, but their instruction manuals and package labels must indicate the words “For research only, not for clinical diagnosis”. For special substances that do not have diagnosis functions without any modification, and can become compositions of in-vitro diagnosis reagents only after markin

36、g or optimization, the registration neednt be applied for. When put on the market for sales, such substances shall be furnished with information about their origins, compositions, titers or active units, etc. and indicated with the words “For research only, not for clinical diagnosis” in the meantim

37、e. Article 16 The State Food and Drug Administration is responsible for defining the classification of in-vitro diagnosis reagents, and making adjustment according to such circumstances as product risk. As for in-vitro diagnosis reagents that cannot be defined according to the above classification p

38、rinciples, the registration applicant shall put forward the application for classification definition with the State Food and Drug Administration. The application for classification definition shall be submitted together with the general summary materials, product instructions, and information about

39、 the classification of similar products in domestic and foreign registration and administration. Article 17 In-vitro diagnosis reagents applying for registration shall adopt general names in compliance with the naming principles. Naming principles for in-vitro diagnosis reagents: product names of in

40、-vitro diagnosis reagents are generally composed of three parts: First part: name of the substance tested. Second part: usage, e.g. diagnosis serum, diagnostic reagent cartridge, quality control, etc. Third part: method or principle, e.g. enzyme linked immunity method, colloidal gold method, etc., t

41、his part shall be listed in parentheses. If the substance for inspection have too many components or under special circumstances, the substance can adopt the indication name related to the product or other substitute names. Chapter 3 Product Research and DevelopmentArticle 18 Organizations engaged i

42、n the research and development of in-vitro diagnosis reagents shall have the personnel, site, equipment, instruments and management system that match the project of experiment and research, use laboratory animals, reagents and raw materials, etc. that comply with relevant requirements and provisions

43、, and guarantee the authenticity of all the experimental data and materials. Article 19 The product research and development work done for applying for the registration of in-vitro diagnosis reagents shall include: selection and preparation of main raw materials; determination of the product manufac

44、turing process; formulation of registered product standards; product stability research, reference value (reference scope) determination, product performance evaluation, etc. The applicant can either carry out product research and development by referring to relevant technical guidance principles, o

45、r adopt different experimental methods or technical means, but shall explain their reasonableness. Article 20 Product performance evaluation refers to the evaluation on the analytical performance and clinical performance of the in-vitro diagnosis reagents. Analytical performance mainly includes anal

46、ytical sensitiveness, analytical specificity, diagnostic scope, diagnostic accuracy, within-run imprecision, between-run imprecision, etc. Analytical performance mainly includes clinical sensitiveness, clinical specificity, etc. Article 21 The registration applicant can either independently accompli

47、sh or entrust relevant research organizations to accomplish the research and development of in-vitro diagnosis reagents, and the evaluation of analytical performance. The registration applicant shall provide application materials indicating the name list of entrusted items, attached with agreement o

48、f both parties, and guarantee the authenticity of all the experimental data and materials. Article 22 The clinical performance evaluation of in-vitro diagnosis reagents shall be accomplished through clinical experiments. The clinical experiments of in-vitro diagnosis reagents shall be accomplished b

49、y the applicant before putting forward the application. The relevant provisions in Chapter 4 of the Measures apply to the requirements on clinical experiments. Article 23 The State Food and Drug Administration and authorities of drug supervision and administrations in provinces, autonomous regions a

50、nd municipalities directly under the central department carry out verification on the product research and development situation in their administrative areas when necessary, require the applicants or research organizations undertaking the experiments to conduct experiments repeatedly according to t

51、he material items, methods and data for the application, and assign personnel to verify the experiment process on the site, or entrust relevant research organizations to conduct the experiments repeatedly. Chapter 4 Clinical ExperimentArticle 24 The clinical experiment of in-vitro diagnosis reagents

52、 (clinical validation including comparative research with the products already put on the market) refers to the systematic research on the clinical performance of in-vitro diagnosis reagents in corresponding clinical environment. Article 25 The specimens for clinical experiment shall be prepared at

53、the workshops that conform to the requirements of the Detailed Rules for the Implementation of the Production of In-vitro Diagnosis Reagents, and the production process shall be in strict compliance with the requirements of the Detailed Rules for the Implementation of the Production of In-vitro Diag

54、nosis Reagents. Article 26 The applicant can either independently conduct the inspection of specimens for clinical experiment according to the product standards formulated, or entrust other competent inspection organizations to conduct the inspection, and only after qualifying for the inspection can

55、 the specimens be used for clinical experiment. Article 27 When the same registration application includes different packaging specifications, the specimens of one packaging specification can be adopted to conduct the clinical experiment. Article 28 The applicants for Class III products shall choose

56、 no less than 3 (including 3) provincial-level health & medical institutions, and the applicants for Class II products shall choose no less than 2 (including 2) provincial-level health & medical institutions to carry out the clinical experiment. For special-purpose products, the clinical exp

57、eriment can be conducted at such organizations as disease control centers, specialized hospitals or inspection & quarantine institutes and detoxification centers above the municipal level that meet the requirements. Article 29 The organizations of clinical experiment shall have the personnel, si

58、te, equipment, instruments and management system that match the research project, and guarantee the authenticity of all the research data and materials. The organizations and personnel participating in the clinical experiment shall understand the responsibilities and obligations of the personnel of

59、clinical experiment, and make records of clinical experiment in a timely way, accurately and faithfully. Article 30 The applicant shall sign a clinical experiment contract with the clinical experiment organization, formulate and perfect the clinical experiment scheme by referring to relevant technical guidance principles, provide specimens for clinical experiment free of charge, and pay the