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GHTF Singapore meeting outcome statement - PDF (56kb)

赵静曼 11/6/2022 浏览 114 GHTF 全球

标准简介

Singapore meeting outcome statement - PDF (56kb)[附网盘链接]是于之前发布的GHTF标准，适用于全球。

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Singapore meeting outcome statement - PDF (56kb)[附网盘链接]
Singapore meeting outcome statement - PDF (56kb)[附网盘链接](截图)

 

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标准部分原文

Outcome Statement

of the IMDRF Management Committee

28 February to 1 March 2012

The inaugural meeting of the International Medical Device Regulators Forum (IMDRF) was

held in Singapore from 28 February to 1 March 2012 and was a great success. IMDRF made

several positive steps forward in developing the new Forum, as well as plans for transitioning

several key items from the Global Harmonization Task Force (GHTF) by the end of 2012.

On the first day of the Forum the regulators from Australia, Brazil, Canada, Europe, Japan,

and the United States of America met to agree on the Terms of Reference for IMDRF and to

discuss proposals for new work items. Regulators from China and the Russian Federation

also attended as observers, along with representatives of the World Health Organization.

The Management Committee agreed on a Terms of Reference document, which is now

available at www.imdrf.org. In accordance with the Terms of Reference, the document will

be reviewed annually. The Management Committee agreed that the next task is to develop

more detailed operating procedures to cover issues such as membership criteria for the

Management Committee and Working Groups, as well as procedures for document handling.

IMDRF will develop a pathway, in advance of the September 2012 IMDRF meeting, for

other regulators to become new members or observers for future meetings.

The Management Committee also agreed to develop a formal strategy for the management

and maintenance of GHTF documents.

Regarding proposals for work items, the following topics were submitted prior to the meeting

and discussed:

a. A review of the NCAR system

b. Roadmap for implementation of a UDI system

c. Standardized submission requirements for pre-market assessment of medical

devices

d. Medical Device Single Audit Program (MDSAP)

e. Non-clinical and clinical evaluation regarding nanomaterials

f. International Standards recognized by IMDRF Management Committee

members

g. Guidance on how to determine risk/benefit analysis

h. Regulated Product Submission.

c/o Monitoring & Compliance Group, Therapeutic Goods Administration

PO Box 100, WODEN ACT 2606 Australia

Telephone: +61 2 6232 8700 Facsimile: +61 2 6232 8687 Email: imdrf.chair@tga.gov.au

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