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GHTF Regulatory Authority Assessor Competence and Training Requirements - PDF (689kb)

赵静曼 8/19/2022 浏览 222 GHTF 全球

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Regulatory Authority Assessor Competence and Training Requirements - PDF (689kb)[附网盘链接]是GHTF于不久之前发布的GHTF标准，适用于全球。

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Regulatory Authority Assessor Competence and Training Requirements - PDF (689kb)[附网盘链接]
Regulatory Authority Assessor Competence and Training Requirements - PDF (689kb)[附网盘链接](截图)

 

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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 implement the concept of a Medical Device Single

Audit Program (MDSAP). Two documents, IMDRF MDSAP WG N3 一“Requirements for

Medical Device Auditing Organizations for Regulatory Authority Recognition" and IMDRF

MDSAPWGN4一“Competence and Training Requirements for Auditing Organizations," are

complementary documents. These two documents N3 and N4 are focused on requirements for

an Auditing Organization and individuals performing regulatory audits and other related

functions under the respective medical device legislation, regulations, and procedures required in

its regulatory jurisdiction.

Two additional documents, IMDRF MDSAP WG N5 - "Regulatory Authority Assessment

Method for the Recognition and Monitoring of Medical Device Auditing Organizations” and this

document, IMDRF MDSAP WG N6 懒“Regulatory Authority Assessor Competence and τraining

Requirements," are complementary documents. These two documents N5 and N6 are focused on

how Regulatory Authorities and their assessors will evaluate or "assess” medical device Auditing

Organizations’ compliance to the requirements in the IMDRF MDSAP N3 and N4 documents.

In addition, IMDRF MDSAP WG NI l will define a method to “ grade" nonconfonnities

resulting 白句orηa RegulatorγAuthor y assessment of an Auditing Organization and to documen t

the decision process for recognizing an Auditing Organization or revoking recognition.

This collection ofIMDRF MDSAP 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 perfotm regulatory audits and other related乱mctions.

It should be noted that in some jurisdictions the recognition process is called designation,

notification, registration, or accreditation.

IMDRF developed MDSAP to encourage and support global convergence ofregulatory systems,

where possible. It seeks to strike a balance between the responsibilities of Regulatory

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

unnecessary burdens upon Auditing Organizations or the regulated industry. IMDRF Regulator y

i气uthor‘ es rηay add additional requirements beyond this document 飞凡1hen their legislatior 1

requires such additions.

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

demonstrated and maintained by RegulatorγAuthorities for personnel involved in the assessment

of Auditing Organizations performing regulatory audits of medical device manufacturers.

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