Oct 19

Guiding Principles for Medical Device Evaluation and revision management

Chapter I General Provisions

The first medical device to regulate the technical review guidelines (hereinafter referred to as "Guiding Principles") in the formulation and revision work to develop this approach.
Within the meaning of Article II "Guiding Principles" means the "Medical Device Registration", "in vitro diagnostic reagents Registration" (Trial), combined with China's actual medical device technology review, as

Medical Device Registration application provides technical reference and to evaluate the safety of medical devices, guiding the technical requirements of effectiveness.
Article "guiding principles" of the formulation and revision should be fully listen to the views of all interested parties. In the "guiding principles" of the development and revision process, it should be a timely manner to the public in an effective manner.
Article participate in the "Guiding Principles" development and revision of offices and personnel, should be the implementation of this approach.
Article These measures apply to the Medical Device Evaluation Center is responsible for the organization of "guiding principles" to develop and revision.

Chapter II work organization and responsibilities
Article VI of the annual plan to consider approval of the central office will be "guiding principles" formulated and revised work programs and other documents published report.
"Guiding Principles" Article central office responsible for the unified organization, management and coordination of the development and revision of specific issues, is responsible for the center's office.
Article VIII of the central offices of each review in charge of "guiding principles" of the formulation and revision, as required to complete the "guiding principles" of the various stages of development or revision of the manuscript.
Article IX is responsible for the review of five "guiding principles" of the information maintained.

Chapter 3, "guiding principles" of the development program
Article X of the central offices of each review to deal with daily work found universal technical issues to be studied by the need to develop "guiding principles" approach to be described in detail, various offices should review July 1 of each year Recently proposed "guiding principles" for the next year to plan, review and report to the central office. Plan should include "guiding principles" of the title, group settings, is expected to schedule, meeting plan, project budget and description.
Article XI central office to develop "guiding principles," according to the plan proposed by the various offices of the formulation of the review of the annual plan and program of work will be reported to the central office for approval. Annual plan and program of work should include the year the center intends to develop a "guiding principles" of the subject, the research group set up, progress overall requirements and budget issues.
"Guiding Principles" Article 12 central office will consider approval of the development plan and the annual work program of work should be promptly sent to the relevant offices, the offices should be in accordance with the requirements of the relevant annual plan and program of work to complete various tasks.
Article 13 of each group according to the plan to finalize the draft "Guiding Principles" (draft) and preparation instructions, should convene to discuss personnel. Manuscript content to be matured, discussed and agreed by the host offices, reported the central office audited and approved by the director in charge, the formation of the draft and preparation instructions. Task Force should adopt the Internet, mail and other means to solicit the views of all stakeholders.
Article XIV Each group should be based on various aspects of the draft feedback changes discussed and agreed by the host offices, reported the central office director in charge of the audit and after the approval of the formation and preparation of the manuscript described by subject organize relevant personnel group discussions held finalized.
Article XV of the manuscript should be based on group discussions will be finalized modify views, discussed and agreed by the host offices, the central office after the audit report form for Approval and preparation instructions, drew the central office for consideration.
"Guiding Principles" Article XVI through the central office will be reviewed and reported to the State Board for approval publish, and simultaneously posted on the Web site.
Article XVII Each group can be developed based on "guiding principles" of the actual situation on the adjustment program, but must have the draft and draft for approval in principle.
Article 18 All group in the "guiding principles" of the development process, the conference program can be adjusted according to the actual work situation. For the proposed increase in the Conference shall submit a written application group, the reasons for the increase and budget meetings, where the offices by consent, reported the central office reviewed and approved by the Director of the Centre. For the proposed reduction of the meeting, shall submit a written application group, indicating the reasons for reducing the meeting, the consent shall be reported to the central office where the offices of the record.

Announced the fourth chapter, "Guiding Principles" and the release
Article XIX publication refers to the development of the process of "guiding principles" at all stages of the manuscript publicly available. "Guiding Principles" by the Central Office for examination and approval of the draft, the draft for approval shall be published in the same period outside center online.
Diershitiao released by the National Bureau of Auditing "guiding principles" of the publicly approved, releases should be placed at the center outside the network over the same period.

Amendment Chapter 5, "Guiding Principles"
Article 21 Each review offices should actively collect and collate published "guidelines" and present a variety of work-related offices in the implementation process feedback information in their daily work, at home and abroad to track technical issues The progress. For indeed there is a need to revise the "Guiding Principles", all divisions should be made next year review "Guiding Principles" revised plan on July 1 each year, reported the central office for review. Plan should include "guiding principles" of the title, group settings, is expected to schedule, meeting plan, project budget and description.
Article 22 The central office to develop "guiding principles" revision of the annual plan and program of work in accordance with the respective offices review the proposed revised plan submitted to the central office approval. Annual plan and program of work should include proposed amendments to the annual central "guiding principles" of the subject, the research group set up, progress overall requirements and budget issues.
Article 23 of the respective offices should review the revised plan will be approved by the central office, organizational procedures specified in each group to work with reference to the third chapter, a "guiding principle" of the various stages of the revised manuscript.
Article 24 of the revised "Guiding Principles" all stages of the manuscript published and released to perform in accordance with the provisions of Chapter IV.

Chapter 6, "guiding principles" to develop and revise management
Article 25 The central office regularly organize the relevant offices of the "guiding principles" to develop the quality of work and the implementation and revision of the work plan to be checked.
Article 26 of each group to designate a person responsible for the formulation and revision process archives collection, storage and finishing work, and at the end of work after the file transfer center office unified archiving.
Article 27 in the "guiding principles" to develop and revision process, the relevant offices organized manuscript review meetings or seminars on internal issues, should be reported to the central office for the record time is determined after the meeting, the central office shall be coordinated meeting place, to avoid conflicts.
Article 28 as Task Force personnel are changed, the situation changes in the offices should be reported to the central office personnel record.
Each review offices Article 29 of the offices in the center of the annual year-end should be "guiding principles" of the development or revision to summarize and report the case of a central office, central office for each review submitted offices the situation will be summarized and reported to the central office. Central office will be on the center of the annual "Guiding Principles" developed or revised completion consideration, the task is completed good offices and individuals, the center will be rewarded in an appropriate manner.

Chapter VII Supplementary Provisions
Article 30 Each group should be strictly in accordance with the "Guiding Principles" style and format (see Annex) requirements, the completion of "guiding principles" of the formulation and revision.
Article 31 These Measures shall be interpreted by the central office.
Article 32 These Measures shall be from the date of publication.

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