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(Edition 4) IMDRF Terms of Reference - PDF (208kb)

赵静曼 5/25/2022 浏览 210 (Edition 4) 世界

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IMDRF Terms of Reference - PDF (208kb)[附网盘链接]由IMDRF Management Committee于27 July 2018发布，适用于世界。

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IMDRF Terms of Reference - PDF (208kb)[附网盘链接]
IMDRF Terms of Reference - PDF (208kb)[附网盘链接](截图)

 

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IMDRF/MC/N1FINAL:2018 (Edition 4)

___________________________________________________________________________________________________

International Medical Device Regulators Forum

Terms of Reference

I. Introduction

A. Mission

The mission of the International Medical Device Regulators Forum (IMDRF) is to

strategically accelerate international medical device regulatory convergence to promote

an efficient and effective regulatory model for medical devices that is responsive to

emerging challenges in the sector while protecting and maximizing public health and

safety.

B. Goals

IMDRF is established to address the common public health regulatory challenges to

convergence due to the globalization of medical device production and the emergence of

new technologies. IMDRF provides the structure where the strategic decisions and

operational mandates are made by public health-missioned medical device regulators,

based on appropriate, equitable and transparent input from stakeholders.

C. Objectives

The objectives underpinning the goals of IMDRF are to:

• Accelerate international medical device regulatory convergence

• Support innovation and timely access to safe and effective medical devices

globally

• Promote open discussion and the sharing of best practices among regulatory

authorities responsible for medical device regulation

• Facilitate frequent exchange of policy and regulatory information of common

interest to regulatory authorities

• Provide opportunities to identify commonalities and develop approaches to

overcome unnecessary regulatory barriers

• Promote prospective convergence in areas of advanced and innovative

technologies

• Enhance communication, information sharing and scientific exchange among

regulators and a broad range of stakeholders

• Establish develop dialogue with other relevant organizations.

1

"Regulatory convergence" (hereinafter "convergence") is meant to represent a voluntary process

whereby the regulatory requirements and approaches across countries and regions become more

similar or aligned over time as a result of the adoption of the same technical documents, standards

and scientific principles (harmonization) and similar regulatory practices and procedures. The

process of convergence represents an important form of regulatory cooperation which in turn

makes possible additional, enhanced forms of cooperation and collaboration between regulatory

authorities.

27 July 2018 Page 2 of 8

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