General Administration promulgated the standard revision of medical equipment management practices

Pharmaceutical Network December 27 hearing in order to implement the CPC Central Committee General Office, the General Office of the State Council, "on the deepening of the reform review and approval system to encourage innovation in medical devices, medical advice" (Office word [2017] No. 42), according to "Medical Device Standards Management (State Food and Drug Administration Order No. 33) the relevant provisions of the State Food and Drug Administration organized the revision of the "standard revision of medical device management practices" is released.

Special announcement.

food drug Regulatory Authority

December 12, 2017

Article 1 To strengthen the standardized management of the development and revision of medical device standards, the Bank establishes an open, transparent and efficient working mechanism for standardizing and revising medical device standards and improves the quality of medical device standards. This standard has been formulated in accordance with the "Medical Device Standard Management Measures".

Article 2 This Code is applicable to the formulation and revision of national standards and industry standards for medical devices, including the establishment of medical device standards, drafting, verification, solicitation of opinions, technical examination, examination and approval, issuance, implementation and evaluation, revision and errata correction, review and Abolished, and rapid revision of medical equipment industry standard system procedures.

Article 3 The implementation of information management of medical device standards The State Food and Drug Administration Medical Device Standard Management Center (hereinafter referred to as the standard tube center) is responsible for the construction and maintenance of the medical device standard revision information system (hereinafter referred to as the information system).

Article IV of the standard medical device project implementation of the public solicitation system throughout the year.Medical device production and operation enterprise The units, regulators, testing agencies, education and research institutes, social organizations and individuals may submit proposals for project propositions. Proposal units or individuals fill in the "Medical Device Standard Proposal Form" (Appendix 1) through the information system and submit relevant proposals Professional Standardization Technical Committee of Medical Device (hereinafter referred to as Technical Committee), Medical Device Standardization Technical Committee (hereinafter referred to as Technical Committee) or standardized technology focal point (hereinafter referred to as technical focal point).

Article V standard conditions of medical equipment project conditions:

(A) in line with the current state laws Regulations And related regulations

(B) meet the medical device regulatory and medical device industry and technology development needs;

(C) in line with medical equipment standard Planning and medical device standard system requirements, in principle, does not cross with the current medical device standards and has been the project plan project, repeat;

(D) in line with national policies using international standards;

(E) is a mandatory industry standard product standards program projects, in principle, the applicable products should obtain a medical device registration certificate or filing voucher;

(Vi) included in the national industrial planning, major science and technology special standards.

Article 6 Medical and pharmaceutical production and operation enterprises, users, regulatory agencies, testing institutes, educational research institutes, social organizations, etc. may apply to Medical Technical Committee, Technical Committee or Technology Administrative Authorities as medical equipment standards The first drafting unit.

As the first drafting unit must have the following conditions:

(A) business scope and standards involved in the technical content to adapt;

(B) have the relevant scientific research and technology capabilities, representative and high authority in the industry;

(C) have a familiar with the national medical equipment policies and regulations of the technical staff;

(4) Technicians who are familiar with the technical development trends, production levels and requirements of domestic and international standards involved in the standards and understand the current problems and solutions;

(E) standards need to be verified, with verification capabilities.

Article 7 Proposals for project proposals that are not yet clearly classified may be directly submitted to the standard pipe standard center, and the standard pipe standard center entrusts the corresponding technical committees, technical committees or technical focal points to conduct feasibility studies and determine the technical focal point.

A project proposal involving two or more technical committees, technical committees or technology focal points shall be coordinated by the standard control center to determine the technical committees, technical committees or technology focal points that take the lead and cooperate with each other.

Article 8 After receiving the project proposals, the technical committees, technical committees or technical focal points shall, in accordance with the requirements of Articles 5 and 6, conduct an in-depth investigation and study of the project proposal, fully demonstrate and widely listen to the opinions of the stakeholders. The project proposals that belong to the Technical Committee and the CSTAC shall be subject to the approval of all the members. The number of members voting for the meeting shall not be less than 3/4. Two-thirds or more of the members participating in the voting shall vote in favor of the voting members and the opposing opinions shall not exceed 1 / 4, the party passed.

Belongs to the focal point of the technology focal point, the need to organize experts for consideration, the number of experts in principle not less than 15. Technical focal points according to the procedure for public solicitation of experts and publicity. Participate in voting for more than 2/3 of the experts, and the objections no more than to participate One-fourth of voting experts passed.

The contents of the deliberation at least include the project name, standard validity, scope of application and main technical content, the first drafting unit.

Article IX of the project proposal examined and approved, technical committee, technical committee or technical focal points shall submit the project application materials, through the information system to declare.Construction Committee Technical Committee should first submitted to the respective technical committee, After its examination and approval, it shall report to the bidding standard center, and the application for applying for the technical committee or technical focal point shall be submitted to the bidding standard center as required.

Article 10 The standard control center shall make preliminary examination of the project application submitted by the technical committee or technical focal point and meet the requirements of the project application. The standard test center will openly solicit opinions from the public to the public. The open contents include the project name, scope of application and standard validity , The adoption of international standards, the first drafting unit, soliciting opinions for a period of time 1. After soliciting opinions, the standard management center co-ordinates the views of all parties and organize experts to demonstrate.On the examination and approval of the project application, Proposed project proposals, submitted to the State Food and Drug Administration (hereinafter referred to as the Administration).

Article 11 The State Administration of Quality Supervision, Inspection and Quarantine shall review the proposals on the standard projects of medical equipment projects approved by the State Council (hereinafter referred to as the planned projects), publicize the website of the State Administration of Quality Supervision on the 7th after publicity without objection to the State Council The standardization administrative department has given its approval and the industry standard project has been approved by the General Administration.

Article 12 After the approval of the project, the technical committee, technical committee or technical focal point shall organize the implementation according to plan and submit the implementation of the project to the standard control center. an examination.

Article 13 In the process of implementing the approved plan, the adjustment is not allowed in principle. The scope of application of the project to be revoked or changed, the name of the standard (involving the change of scope of the project), the first drafting unit, the effectiveness of the standard, The technical committee, technical committee or technical focal point undertaking the project shall fill in the Application Form for Adjusting the Standard of Medical Device Project (Attached Table 2) and organize the deliberation and consideration again according to the requirements of Article 8 of Chapter II If approved, the Technical Committee or technical focal point will submit the application for adjustment to the standard pipe standard center, and the technical committee will submit the adjustment application form to the Technical Committee for approval. The standard pipe standard center reviews and adjusts the application and submits the adjustment proposal to the SAFE. If the examination and approval are approved, the adjustment of the national standard plan items shall be submitted to the department of standardization administration under the State Council for approval; the adjustment of the industry standard plan items shall be approved by the general bureau and shall be announced by the standard pipe center in the information system. Upon review and disapproval, the technical committee, In accordance with the original plan or technical focal point to carry out standard system revision work.

Article 14 The planned project shall be completed according to the time limit.If it can not be completed on schedule, the technical committee, technical committee or technical focal point who undertakes the project shall submit an application for extension to the standard pipe center at least three months in advance. If the application needs to be postponed, an application for extension shall be submitted to the CTC within one month after the standard review is completed. The standard center shall review the application and submit the application for deferment to the SAFE. Standardization of the administrative department for approval. Approval of the extension of the industry standards, approval of the General Administration of the standard tube center in the information system to adjust the time limit.

Article XV of the same project in principle can apply for an extension of the longest delay of 1 year.

Article 16 The State Administration shall publish the completion of the standard scheme every year.According to the plan of the next fiscal year, the CSRC or the CSRC, which has not completed 80% of the total number of planned projects for the current year and has not been allowed to postpone the project, will be exempted from the project plans for the following year.

Article 17 The technical committees, sub-technical committees or technical focal points shall promptly organize the drafting of standards in accordance with the approved standards and plan projects, and shall be responsible for the standard quality and technical contents.

Article 18 The medical device manufacturing enterprises, users, regulatory agencies, testing institutes, educational research institutes, social organizations, etc. may apply as the drafting unit to the technical committees, technical committees or technical focal points that undertake the planned projects Technical committees, technical committees or technical focal points shall, in accordance with the principles of openness, impartiality and preference, decide to participate in the drafting of the units and participate in the drafting of the units to be representative and give full play to the roles of all relevant parties. If the planned project is a product standard, the participating drafting unit shall, in principle, at least include a production or research institution of the relevant product.

Participate in the drafting unit to be completed, "Medical Device Drafting Unit Registration Form" (Schedule 3), in the commitment of the project plan of the technical committee, technical committee or technical focal points for the record. Participate in the drafting of changes, subject to the technical committee , Technical committee or technical focal points agree.

Article 19 The technical committees, technical committees or technical focal points shall organize drafters of drafting standards for drafting units and set up drafting working groups for drafting standards, and drafters should be drafted by technicians with rich professional knowledge and practical experience. The drafters should fill in the Registration Form for Medical Device Drafters (Attached Table 4) and put them on record at the Technical Committee, Technical Committee or Technology Authorities. The drafters' changes need to be approved by the Technical Committee, Technical focal point agreed.

Article 20 The standard drafting working group is responsible for drafting the standard and determining the first drafter.The first drafter is, in principle, from the first drafting unit responsible for the specific preparation and coordination of the drafting of the standard, etc. The first draftee of the standard shall have Following conditions:

(I) Compulsory standards The first drafter shall have senior professional technical titles or equivalent technical positions in principle. The first draftsmen of the recommended standards shall have professional technical titles or equivalent technical positions of intermediate level and above;

(B) with relevant product testing, research and development, production or quality and technical work experience;

(C) has a certain degree of standardized management and medical device knowledge of laws and regulations;

(D) has good writing skills and a high level of English;

(E) has good organizational management and coordination skills;

(6) Failing to complete the standard work tasks on time and without reason;

Article 21 Standard drafting working group should extensively research, in-depth analysis and research, and actively learn from the relevant international standards, on the basis of fully demonstrating the technical content, according to GB / T 1 "standardization guidelines", GB / T 20000 "Standardization Guide" and other standards prepared by the draft standard drafting requirements.

Article 22 The technical committees, sub-technical committees or technical focal points shall organize the verification of the draft standards, and may publicly solicit the verification units for verification, organize the verification work, analyze the verification results, and draw the verification conclusions.

Article 23 The technical requirements and methods that need to be verified by the test shall be verified by the test, and the technical contents that are not required for the test are to be verified.

Article 24 Before the test is validated, a test plan shall be drawn up which specifies the purpose, requirements, personnel, test subjects, test methods, instruments, equipment, tools, workplaces, working environment and items to be noticed during the test Etc., to ensure the repeatability, reliability and accuracy of the experimental verification conclusion.

Article 25 The same test verification project should be carried out in different enterprises or testing institutions, in principle, at least include a testing agency.

Article 26 The technical committees, technical committees or technical focal points shall keep the completed verification materials according to the standard archiving requirements, and the verification materials shall be accurate, true and clear.

Article 27 The technical committees, technical committees or technical focal points shall, in accordance with the verification conclusions, revise and improve the draft standards to form a draft for medical device standards, preparation instructions and relevant appendices. The contents of the 'preparation instructions' generally include:

(1) Work profiles, including sources of work, units for collaboration, main work processes, standard drafting units and work done by them;

(2) Argument (including test and statistical data) about principle of standard compilation and main contents (such as technical indicators, parameters, formulas, performance requirements, test methods and inspection rules) ;

(3) Analysis of main test (or verification), review report, technical and economic demonstration and expected economic effect;

(4) The degree of adopting international standards and foreign advanced standards, as well as the comparison with the international standards of similar standards or with the data of the tested foreign samples and prototypes;

(5) Relationship with relevant existing laws, regulations and mandatory standards;

(6) The process and basis for handling the opinions of major differences;

(G) advice as a mandatory or recommended standard

(Viii) the implementation of the standards and measures recommended (including organizational measures, technical measures, transitional measures, the implementation date, etc.);

(9) To abolish the existing relevant standards;

(X) Other things to be explained.

Article 28 The technical committees, sub-technical committees or technical focal points shall, upon request, report standard draft for soliciting opinions and preparing explanations to the standard control center, and seek opinions from the members and relevant departments at the same time. Social open for comments.

Article 29 When soliciting opinions, it is necessary to specify the deadline for soliciting opinions, which is usually two months, and the unit that solicits opinions should reply its opinion within the prescribed time limit. If there is no opinion, No objection to the treatment of major opinions, need to explain the argument or technical argument.

Article 30 The technical committees, technical committees or technical focal points are responsible for collecting the collected opinions and submitting them back to the standard drafting working group, which is responsible for studying the opinions collected and putting forward opinions on how to deal with them. The Summary Form for Soliciting Opinions of Medical Devices (Appendix 5) shall be reported to the Technical Committee, Technical Committee or Technical Authorities for comment. The solicitation opinions shall be handled as follows: Adopted, partially adopted, and not examined and adopted by the technical review stage For reasons of "partial adoption", "discussion at the technical review stage" or "non-adoption", the justification should be given.

Article 31 The technical committees, technical committees or technical focal points shall examine and approve the solicitation of comments, and if the opinions sought are large, the technical committee, the technical commission or the technical focal point shall conduct investigation and research Or supplementary verification work, depending on the circumstances whether to seek comments again.

Article 32 In accordance with the handling of soliciting opinions, the working group shall draft the revised standard draft for soliciting opinions and relevant materials, and form standard draft for examination, compilation of explanation, verification report, summary opinion sheet and relevant attachments.

Article 33 The technical committees, technical committees or technical focal points shall be responsible for organizing the technical review of the standard draft for examination, which shall be divided into two types: the review of the meeting and the correspondence and hearing, and the compulsory standards, the major basic recommended standards , The standard of patent involved and the suggestion of more standard suggestion draft for review are subject to conference review, and if necessary, the standard can be pre-reviewed before the meeting or correspondence, and the pre-trial conclusion is not used as the basis for approval criteria.

Article 34 During the meeting review, the technical committee, technical committee or technical focal point shall submit the standard materials for examination and approval, compilation instructions and solicitation opinions for submission to the full committee or reviewers within 10 working days in advance expert.

Article 35 When applying for correspondence examination, the technical committee, technical committee or technology focal point shall submit the materials for examination and the letter of examination and approval for medical device standard (Attachment 6) to all the members or experts for examination and approval, And provides for the reply deadline, generally not less than 1 month.

Article 36 The standard drafting working group shall explain the main technical contents of the standard, preparation work process, solicit opinions and handling conditions, and explain the meanings and basis of the technical requirements in the standard. Should be truthfully and accurately answered, to adopt a reasonable part.

Article 37 The standard plan of medical device projects undertaken by the technical committee and the technical committee shall be responsible for organizing the voting of all the members. The number of members participating in the voting shall not be less than 3/4 of the total members. More than two-thirds of the voting members voted in favor of the voting, and no more than one-fourth of the votes cast voted against the resolution. The members did not attend the meeting and did not entrust their representatives to attend the meeting or the hearing failed to vote on time , Abstaining from voting.If the examination members of the meeting (including members' representatives) attend less than 2/3, the examination shall be restructured.

Technical standardization unit for medical equipment projects undertaken by the technical focal point, the technical focal point is responsible for organizing experts to vote, in principle, the number of not less than 15, not less than three-fourths of the experts participating in the vote. More than two-thirds of voting experts , And no objection to vote more than one-fourth of voting experts, was adopted.

Article 38 The technical committees, technical committees or technical focal points shall formulate the minutes of the conference review (letter trial) and fill in the "Conclusion Table of Technical Examination of Medical Device Standards" (Schedule 7 ), And reviewed and approved by the members or experts.Meeting review (correspondence trial) discipline should accurately reflect the review, including the review of time and place, the participation of reviewers and units, review the review of the draft for review, the The preparation of the contents of the review conclusion, etc. The review conclusion is divided into 'passed', 'modified after adoption', 'failed' three cases.

Article 39 For the drafting units organized by the technical committees, technical committees or technical focal points for reviewing the conclusions as 'passed' or 'passed after revision', the standard drafts shall be revised and perfected according to the examination opinions Submitted draft for approval, implementation of the recommendations (including the implementation date, determine the date of implementation of the basis) and other materials.

For those who fail to pass the examination, the technical committee, technical committee or technology focal point shall reorganize and review according to the review opinions.

Article 40 The Technical Committee or the technical focal point shall submit the approved materials such as the standard draft for approval, the implementation suggestions, etc. to the standard test center, and the technical committee will report the approved materials to the technical committee as required, and the technical committee shall, within 30 working days Within the completion of the review, after the review passed to the standard test center.

Article 41 The standardization center shall review the standard revision process, the coordination of draft approval, the completeness and normativity of the submitted and approved materials, and the examination shall be completed within 60 working days, and the supplementary information shall not be counted within the examination time limit If necessary, experts can be organized for technical demonstration.For the need to improve the reporting materials, marking the center in the information system to the Technical Committee, Technical Committee or technical focal points to submit their opinions.Technical Committee, Sub Technical Committee or Technical focal point within 30 working days according to the audit opinion submitted relevant materials.If the standard draft for approval and its relevant approved materials do not meet the requirements of the standard center will apply for approval of the relevant materials returned to the Technical Committee, Technical Committee or technical focal points, By the Technical Committee, Technical Committee or Technical focal point after revision and re-submit.

Article 42 The medical equipment national standards, technical committees or technical focal points that have been examined and approved shall be reported in the management information system for the revision of the national standard system, and the medical equipment industry standards reviewed and approved shall be submitted to the standards center for approval and relevant documents Materials sent to the standard publishing unit for review, in case of doubt feedback standard tube center.

Article 43 The standardization center shall submit the national standards of medical devices reviewed and passed and the approval documents for approval of the medical device industry and the related materials submitted to the SAFE for review and approval, and submit the approved and published national standards to the department of standardization administration under the State Council for approval and release. The industry standards reviewed and approved by the General Administration, and determine the implementation date and implementation requirements, published in the form of announcements, if necessary, put forward guidance on the implementation of the standard.

Medical equipment national standards, industry standards in accordance with the relevant provisions of the public for public inspection.

Article 44 The technical committees, sub-technical committees and technical focal points shall conduct standard publicity and training after the standard is released, and when necessary, the standard pipe standard center may organize the publicity and training of mandatory standards and major basic standards.

Article 45 Relevant units or individuals that have found problems during the implementation of the standards may give feedbacks to the technical committees, technical committees or technical focal points that are under centralized control of the standards.For the problems of feedback, the technical committees, sub-technical committees or Technical focal points should organize research and propose solutions for bidding management center.

Article 46 The technical committees, sub-technical committees or technical focal points shall follow up and evaluate the implementation of the standards and report back to the standard control center in time.For mandatory standards for medical equipment, the standard management center shall, according to the follow-up evaluation, Statistical analysis of the implementation of sex standards.When necessary, the standard tube center can organize the relevant units, experts to carry out mandatory standards for medical devices, evaluation of the implementation of major basic standards, make recommendations to the Administration.

Article 47 After promulgation and implementation of medical device standards, due to the influence of individual technical content on the use of standards that need to be modified, standards and amendments shall be adopted in a single modification. Relevant entities or individuals may report to the standard technical committee, technical committee Or technical focal points to propose standards changes.Technical Committee, Sub-Technical Committee or technical focal point with reference to the deliberation of the project proposal to determine whether the need to change.

Article 48 Amendments to standards should be drafted and solicited for opinions, technical examination and approval by the technical committee, technical committees or technical focal points under the standard centralized management in accordance with the standards for the revision of medical devices. May be shortened.

Article 49 The standardization center shall examine and approve the revision of medical device standards, the proposal of modification of single application and the relevant approved materials for examination and approval by the General Administration of the People's Republic of China.After reviewing and approving the revision of the national standard for medical devices and the relevant approval documents, it shall be sent to the competent department of standardization administration under the State Council Approval, release.After review and approval of the medical device industry standard single, approved by the General Administration, to determine the implementation date and implementation requirements, and to be released.

Article 50 If there is any alteration or alteration of the technical indicators or contents after the medical device standard is published and published, no ambiguity in standard comprehension will be produced after the errata correction, and the unit that published the concerted errata shall be reported to the publishing unit and copied Delivery standard tube center.After approval by the standard publishing unit to be errata, errata released or errata instructions, to be corrected when the standard is printed again.

Article 51 The technical committees, sub-technical committees, or technical focal points shall conduct a review of the published and implemented medical device standards. According to scientific and technical progress, industrial development and supervision, their effectiveness, applicability and advancement are required Timely review of the organization.The review cycle in principle, no more than 5 years.Review can use the conference review or correspondence trial, the standard review procedures and requirements need to refer to Chapter VI technical review of the relevant provisions, the formation of the review conclusion.The review conclusion is divided into 'continue to be effective' , 'Revised' or 'revoked'.

Article 52 After the standard review, a review report shall be formed by the technical committee, technical committee or technical focal point. The report shall include the review profile, the review procedure, the opinions of the review and the conclusion of the review, and shall report the standard review materials to the Target Management Center The submitted materials shall include the official documents, the standard review report, the standard review item summary table, and the "Conclusion Table of Medical Device Standard Review" (Schedule 8).

Article 53 After passing the review conclusion, the bidding center shall be submitted to the General Administration for examination and approval, and the conclusions of the review of the national standards for medical devices shall be submitted to the department of standardization administration of the State Council for approval; the conclusion of the standard review of the medical device industry shall be examined and approved by the State Council.

Article 54 The conclusion of the review shall be the 'continue to be valid' medical device standard, and the original standard number and year number shall be maintained, and the website shall be identified on the website of the general bureau.

Article 55 The reexamination conclusion is the 'revised' medical equipment standard. The technical committee, technical committee or technical focal point of centralized department shall submit the project application in accordance with the project approval, organize the revision after the approval, or amend it through the revision list.

Article 56 The national standards for medical devices concluded as "abolished" shall be annulled according to the provisions of the standardization administrative department of the State Council, public announcements shall be made on the industrial standards for medical devices that need to be abolished, and public announcements shall be made to annul them .

Article 57 The urgent need for the revision of medical equipment industry standards, the adoption of fast procedures.

Article 58 According to the urgent need of supervision, the State Administration shall organize the research and development of standard test centers to determine the standard project plans and the technical committees, technical committees or technical focal points responsible for the planned projects.

Article 59 The technical committees, technical committees or technical focal points shall promptly organize the drafting, soliciting opinions and technical examination, and the standardization center shall complete the examination and approval in time and the approval of the general administration for examination and approval shall be made in time. The relevant time limit may be appropriately shortened.

Article 60 The technical committees, sub-technical committees or technical focal points shall keep relevant documents and materials in the process of standard-setting and revision in accordance with the relevant provisions of the "Standard Records Management Measures" and other relevant documents and materials, including project proposals, draftsmen registration forms, Documents, meeting minutes, standard validation polls, etc. The archived materials should be authentic and traceable.

Article 61 The standards of medical devices that have been approved for publication belong to the scientific and technological achievements and may serve as the basis for the relevant personnel to apply for scientific research awards and to participate in the professional and technical qualification review.

Article 62 The management of technical committees, sub-technical committees or technical focal points shall comply with the relevant provisions.

Article 63 The Rules shall enter into force as of the date of promulgation, and the "Specifications for the Revision of Medical Device Industry Standards (Trial)" (State Food and Drug Administration 〔2007〕 238) promulgated on April 6, 2007 shall be repealed at the same time.