In accordance with the provisions of the Interim Measures for the Management of New Medical Devices (hereinafter referred to as "the Measures"), the identification approval is divided into "prototype identification approval number" and "production identification approval number" through the "prototype (sample) identification"; through the production identification of "production identification approval number" issued. Prototype (sample) identification, the issuance of "prototype (sample) identification approval number"; through the production identification, the issuance of "production identification approval number. Prototype (sample) identification and production identification of new medical devices identified by the combined appraisal of the completion of the identification of medical devices directly issued after the "production identification approval number". Second, the identification of the form of approval number
"Prototype identification approval number" in the form of: "× medical device test word ( ) No.", "production identification approval number" in the form of: "× medical device approval () No.". Third, the form of new medical device product identification and approval of the chapter
New products through the prototype identification or production appraisal, identification by the organization unit issued by the "identification of scientific and technological achievements certificate" (see Annex IV), "new medical device product identification and approval of the chapter," stamped in the "scientific and technological achievements certificate" (see Annex IV), "new medical device product identification and approval of the chapter. In the "identification of scientific and technological achievements certificate" in the upper left corner, to show the effect. Appraisal approval seal in the form of:
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Prototype (sample) identification approval number of the identification of the approval of the seal will be the above drawings in the "Quasi" word replaced by the word "test", other forms remain unchanged. Fourth, the use of identification approval number
(a) the number and text fill in the provisions:
1. Identification approval number in parentheses should be filled in the last two digits of the year of approval. For example: 1989 approval, fill in the "89" two digits.
2. Appraisal approval number "×" should be filled in the organization identification unit code. For example: the State Administration of Medicine into the "State" word, the Shanghai Municipal Administration of Medicine into the "Shanghai" word.
3. Appraisal approval number of the code for the 6-digit number. For example: "State Medical Device test word (89) No. 291015". Where: the first three digits is the computer identification number, the last three digits is the product approval number.
4. The first three computer identification number has three uses, respectively, can indicate the product classification, the termination of the trial period of new products or product categories.
(1) the first digit in the prototype (sample) identification approval number and production identification approval number are indicated that the product according to the "methods" of product classification.
"1" on behalf of the first category of new products, "2" on behalf of the second category of new products, "3" on behalf of the third category of new products.
In the above example represents the second category of new products.
(2) The second and third digits of the prototype qualification approval number represent the year of termination of trial production of the product. In the above example, it means that the product must stop trial production in 91, or it is considered that in 91, the appraisal approval number has lapsed.
(3) the second and third digits in the production identification approval number represents the type of product, such as electronic products, X-ray products, etc., the product variety of code separately.
(4) regarded as a new product prototype identification approval number or production identification approval number of the first digit as follows:
"4" on behalf of the first category of new products, "5" on behalf of the second category of new products, "6" on behalf of the second category of new products, "6" on behalf of the second category of new products, "6" on behalf of the second category of new products, "6" on behalf of the second category of new products. "6" represents the third category of new products.
5. The last three numbers for the appraisal and approval of the current year's running number, identified by the organization identification unit.
(B) the trial period to extend the identification of approval number change
In the trial period, the completion of the required trial production tasks need to extend the trial period, should apply for procedures. This includes the identification of the approval number of changes in the identification of the approval number refers to changes in the prototype identification of the approval number of the second and third digits, so that it indicates a new termination period.
According to the above provisions, the State Administration of Medical Science and Education Department of the results of the establishment of the identification of the approval number of the computer management system in order to facilitate the query of the various departments, to strengthen market supervision. V. Organization appraisal unit opinion
Covered
Year Month Chapter II Classification and Grading Management of New Medical Device Products VI. Main Technical Documents Directory and Providing Units VII. List of Principal Investigators
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Number｜Name｜Age｜Education｜Specialty｜Title｜Position｜Working Organization｜Creative Contribution to the Achievement
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Chapter III Development of New Medical Device Products VIII. List of Appraisal Committee
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Serial No.｜Title of Appraisal Committee｜Name｜Working Unit｜Specialty of Study｜Current Specialty｜Title of Position｜Signature
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Instructions
1. Suggested classified level: to be filled in by the appraisal unit. It means that on the basis of the self-reporting of the unit applying for appraisal, the classification level is determined after discussion by the Appraisal Committee.
2. Approved classified and numbered: according to the relevant provisions of scientific and technological confidentiality, with the right to approve the classified approval unit approved classified and numbered.
3. No.: the identification of the approval number will be determined in the identification certificate cover seal, the number should be in accordance with the requirements of the Interim Measures for the Management of New Medical Devices coding.
4. The results of the completion of the unit: refers to participate in the development of the results and make creative contributions to the technical units, according to the size of the contribution in order.
5. Appraisal form: refers to the results of the appraisal of the form used, that is, testing and appraisal or acceptance appraisal or expert review.
6. Brief description of the results: fill in by the unit applying for identification. The main content includes the source of the task, the purpose of the study and the characteristics of the results. If the Department of applied technology results, should be written in its main economic and technical indicators, industrialization experiments. If the Department of science and theory results, should be written in its basic arguments, arguments, academic significance and be cited. If the Department of soft science results, should write the theoretical basis and application effects.
7. Prospects for popularization and application and benefit prediction: fill in by the unit applying for appraisal, refers to the results of the scope of popularization and application of the results of the economic or social benefits of quantitative prediction. Forecast of the benefits should be attached to the calculation method and basis.
8. Appraisal opinion: refers to the appraisal of the results of the appraisal committee to make a realistic evaluation, in particular, should indicate the different opinions, pointing out the problems and suggestions for improvement. Appraisal of the specific content of the opinion according to the "Interim Measures for the Management of New Medical Devices" requirements.
9. Preside over the appraisal of the unit's opinion: by the specific unit to preside over the appraisal of the results to fill in.
10. Organizational appraisal unit comments: according to the requirements of the classification of new medical device products, by the State Administration of Medicine or provinces, autonomous regions, municipalities directly under the Central Medical Bureau or provincial people's government is responsible for filling out the medical management department to show that the entry into force.
11. The main researchers list: refers to the substantive features of the results of the creative contribution to the personnel, according to the order of contribution.