imdrf标准操作程序.docx

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1、 imdrf标准操作程序操作 标准 程序 IMDRF/MC/N2FINAL:2023 (Edition 6) FINAL DOCUMENT Title: IMDRF Standard Operating Procedures Authoring Group: IMDRF Management Committee Date: 25 September 2023 Dr Choong May Ling, Mimi, IMDRF Chair This document was produced by the International Medical Device Regulators Forum.

2、There are no restrictions on the reproduction or use of this document; however, incorporation of this document, in part or in whole, into another document, or its translation into languages other than English, does not convey or represent an endorsement of any kind by the International Medical Devic

3、e Regulators Forum. Copyright 2023 by the International Medical Device Regulators Forum. Table of Contents 1.0 Introduction . 3 2.0 IMDRF Membership . 3 2.1 Management Committee . 3 2.2 Official Observers . 4 2.3 Invited Observers . 5 2.4 Regional Harmonization Initiatives . 6 2.5 Subcommittee Membe

4、rship . 7 2.6 Working Group Membership . 7 3.0 Development of Technical Documents . 8 3.1 General Principles . 9 3.2 Stage 1 Assignment of Work Items . 9 3.3 Stage 2 Document Development . 11 3.4 Stage 3 Advancement from Working Draft to Proposed Document . 12 3.5 Stage 4 Consultation on Proposed Do

5、cuments . 12 3.6 Stage 5 Advancement from Proposed Document to Final Document . 13 3.7 Stage 6 Publication . 14 4. Development of Information Documents . 15 5. Document Status Designation . 15 5.1 Location of Designation Code . 15 5.2 Working Drafts (WD) . 16 5.3 Proposed Documents (PD) . 16 5.4 Fin

6、al Document . 16 6.0 Review and Revision of IMDRF Documents . 17 6.1 Maintenance of IMDRF Documents . 18 6.2 IMDRF Secretariat and IMDRF Webmaster responsibilities . 18 7.0 Management and Maintenance of GHTF Documents . 19 8.0 Record-Keeping/ Information Archives . 20 9.0 Translation of IMDRF guidan

7、ce documents. 21 10.0 IMDRF-Related Presentations and Training . 22 11.0 IMDRF Logo . 22 ANNEXES . 23 ANNEX A . 24 ANNEX B . 26 ANNEX C . 28 ANNEX D . 29 ANNEX E . 33 ANNEX F . 34 1.0 Introduction This document is intended to describe the basic procedures that the International Medical Device Regula

8、tors Forum (IMDRF) follows when revising the membership of the Management Committee, establishing Subcommittees or Working Groups, developing IMDRF Documents or managing documents developed under the Global Harmonization Task Force (GHTF). The Operating Procedures outlined in this document, in conju

9、nction with the Terms of Reference, are designed to be flexible so that should the need arise, the IMDRF can respond to challenges with respect to its objectives in a timely manner. 2.0 IMDRF Membership IMDRF membership criteria, roles, and responsibilities are listed in each of the Sections below a

10、nd are also outlined in Annex D. 2.1 Management Committee The Management Committee consists of regulatory authorities and is responsible for the oversight and decision making for all IMDRF activities. Management Committee members are voting members and are expected to attend all IMDRF Management Com

11、mittee meetings which are held face to face or by teleconference as well as to ensure regular contribution to IMDRF activities and participate in at least 2/3 of the IMDRF Working Groups. Management Committee members have two (2) representatives per delegation and these representatives need to be kn

12、owledgeable on IMDRF matters. It is expected that these representatives would consistently attend subsequent IMDRF meetings and that any changes to representatives would require notification to the IMDRF Management Committee chair. In reviewing application requests for membership, the Management Com

13、mittee will consider whether the regulatory authority has met each of the following requirements, including having: been a regional influence, participated in all IMDRF MC meetings (including teleconferences) for the last two (2) consecutive years, participated in a majority of Working Groups as an

14、Official Observer for the last two (2) consecutive years, providing active contribution, and been an Official Observer for at least the last two (2) consecutive years prior to the application for membership, and sufficient capacity to chair the MC and provide the Secretariat for a year, including ho

15、sting two (2) face to face meetings and two (2) scheduled teleconferences. Having been an Official Observer for the last two (2) consecutive years prior to the application for membership, while being an essential precondition for Management Committee membership, does not give the applicant any autom

16、atic presumption of conformity with the other criteria listed above. Applications to become a Management Committee member are to be made in writing by completing the application form (located on the IMDRF website) and sending it to the IMDRF Chair. All applications must be submitted at least two (2)

17、 months before the next management committee meeting for consideration. The application(s) will then be reviewed by the Management Committee at the next Management Committee meeting. The Management Committee will ask the applicant to provide a presentation during that meeting. Any new Management Com

18、mittee members will be approved with the unanimous agreement of existing Management Committee members. The membership of the Management Committee will be published on the IMDRF website. 2.2 Official Observers Official Observers consist of Regulatory Authorities and the World Health Organization (WHO

19、) and participate in the oversight of all IMDRF activities, but do not participate in the decision making process. Official Observers will be expected to attend all Management Committee meetings which are held face to face or by teleconference as well as to participate in IMDRF Working groups. Offic

20、ial Observers will be expected to maintain the confidentiality of the “closed” Management Committee meetings per the Terms of Reference document. When a discussion or portion of a Management Committee meeting is designated as “closed” Official Observers may attend. Official Observers do not particip

21、ate in the decision making process. As with full members, Official Observers may have two (2) consistent representatives per delegation and these representatives need to be knowledgeable on IMDRF matters. In reviewing application requests to become an Official Observer, the Management Committee will

22、 consider whether the applicant has met each of the following requirements: being a Regulatory Authority, operating a mature or maturing system for medical device regulation which should include: o established laws and regulations for medical devices building substantially on GHTF and IMDRF foundations and principles, o proper competencies for effective implementati.