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IMDRF/GRRP WG/N63FINAL:2020 Competence and Training Requirements for Regulatory Authority Assessors of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews - PDF (370kb)

赵静曼 7/1/2022 浏览 260 IMDRF/GRRP WG/N63 世界范围

标准简介

Competence and Training Requirements for Regulatory Authority Assessors of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews - PDF (370kb)[附网盘链接]是IMDRF GRRP Working Group于25 September 2020发布的GHTF标准，适用于世界范围。

标准截图

Competence and Training Requirements for Regulatory Authority Assessors of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews - PDF (370kb)[附网盘链接]
Competence and Training Requirements for Regulatory Authority Assessors of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews - PDF (370kb)[附网盘链接](截图)

 

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标准文档类型为Competence and Training Requirements for Regulatory Authority Assessors of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews - PDF (370kb)[附网盘链接]高清PDF版本（文字版），标准文档内可进行搜索，可以复制原文，可粘贴。

标准部分原文

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Introduction

This is one document in a collection of documents produced by the International Medical Device

Regulators Forum (IMDRF) intended to improve the efficiency and effectiveness of the review

process for marketing of medical devices. Two documents, IMDRF GRRP WG/N40 –

Competence, Training, and Conduct Requirements for Regulatory Reviewers and IMDRF GRRP

WG/N59 – Requirements for Medical Device Conformity Assessment Bodies for Regulatory

Authority Recognition, are complementary documents. These two documents are focused on

requirements for organizations conducting marketing review(s) of medical devices and IVD

medical devices and individuals performing regulatory reviews and other related functions under

their respective medical device legislation, regulations, and procedures required in their

regulatory jurisdiction.

Two additional documents, IMDRF GRRP WG/N61 – Regulatory Authority Assessment Method

for Recognition and Surveillance of Conformity Assessment Bodies Conducting Medical Device

Regulatory Reviews and this document, IMDRF GRRP WG/N63 - Competence and Training

Requirements for Regulatory Authority Assessors of Conformity Assessment Bodies Conducting

Medical Device Regulatory Reviews are complementary documents. These two documents N61

and N63 are focused on how Regulatory Authorities will evaluate or “assess” a CAB’s

compliance to the requirements in the IMDRF GRRP WG/N59 and N40 documents.

This collection of IMDRF GRRP documents will provide the fundamental building blocks by

providing a common set of requirements to be utilized by the Regulatory Authorities for the

recognition and monitoring of entities that perform regulatory reviews and other related

functions. It should be noted that in some jurisdictions the recognition process is called

designation, notification, registration, or accreditation.

IMDRF developed these documents to encourage and support global convergence of regulatory

systems, where possible, seeking to strike a balance between the responsibilities of Regulatory

Authorities to safeguard the health of their citizens as well as their obligations to avoid placing

unnecessary burdens upon medical device CABs or the regulated industry. IMDRF Regulatory

Authorities may add additional requirements beyond this document when their legislation

requires such additions.

The purpose of this document is to specify competence and training requirements that shall be

demonstrated and maintained by Regulatory Authorities for personnel involved in the assessment

of Conformity Assessment Bodies performing regulatory reviews of marketing submissions.

The requirements contained within this document are for personnel involved in assessments and

recognition decisions assessing conformity with the IMDRF GRRP WG/N59 document, and

includes:

• Defining knowledge, skills, and abilities.

• Criteria for various degrees of competence based on roles in assessments and recognition

decisions.

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