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IMDRF/GRRP WG/N40FINAL:2017 Competence, Training, and Conduct Requirements for Regulatory Reviewers - PDF (174kb)

赵静曼 9/28/2021 浏览 300 IMDRF/GRRP WG/N40 全球

标准简介

Competence, Training, and Conduct Requirements for Regulatory Reviewers - PDF (174kb)[附网盘链接]是IMDRF Good Regulatory Review Practices发布的GHTF标准，适用于全球。

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Competence, Training, and Conduct Requirements for Regulatory Reviewers - PDF (174kb)[附网盘链接]
Competence, Training, and Conduct Requirements for Regulatory Reviewers - PDF (174kb)[附网盘链接](截图)

 

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标准部分原文

Introduction

This IMDRF Good Regulatory Review Practices document provides a common set of conduct,

education, experience, competence, and training requirements that shall be established and

maintained by the Regulatory Authorities and/or their recognized Conformity Assessment

Body(ies) (CAB) for individuals who perform regulatory reviews of medical devices for

marketing authorization. Depending on individual legislations within various jurisdictions,

additional requirements beyond those in this document may apply.

This document is intended to develop confidence in the consistency of regulatory reviews by

Regulatory Authorities and/or their recognized CAB. Implementation of these practices is

intended to provide an opportunity to rely on regulatory reviews performed by other Regulatory

Authorities and/or their recognized CAB.

1.0 Scope

This document applies to individuals performing regulatory reviews and making decisions

associated with the regulatory review for IVD and non IVD medical devices, on behalf of

Regulatory Authorities and/or their recognized CABs. This document recognizes the use of

Regulatory Reviewers and Technical Experts in the regulatory review process and provides

separate training and competency requirements for each.

This document does not establish competency and training requirements for MDSAP Auditors

and MDSAP Regulatory Authority Assessors. These requirements are already addressed in the

MDSAP working group documents (IMDRF/MDSAP WG/N4FINAL:2013 and

IMDRF/MDSAP WG/N6FINAL:2013).

2.0 References

• GHTF/SG1/N78:2012 Principles of Conformity Assessment for Medical Device

• GHTF/SG1/N71:2012 Definition of Terms Medical Device and In Vitro Diagnostic

Medical Device

• IMDRF/MDSAP WG/N4FINAL: 2013 Competence and Training Requirements for

Auditing Organizations

• IMDRF/MDSAP WG/N6FINAL: 2013 Regulatory Authority Assessor Competence and

Training Requirements

• ISO 9000:2015 Quality management systems — Fundamentals and vocabulary

16 March 2017 Page 4 of 19

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