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IMDRF/MDSAP WG/N3FINAL:2013 Requirements for Medical Device Auditing Organizations for Regulatory Authority Recognition - PDF (244kb)

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标准简介

Requirements for Medical Device Auditing Organizations for Regulatory Authority Recognition - PDF (244kb)[附网盘链接]是IMDRF MDSAP Working Group于9 December 2013发布的GHTF标准，适用于世界。

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Requirements for Medical Device Auditing Organizations for Regulatory Authority Recognition - PDF (244kb)[附网盘链接]
Requirements for Medical Device Auditing Organizations for Regulatory Authority Recognition - PDF (244kb)[附网盘链接](截图)

 

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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 implement the concept of a Medical Device Single

Audit Program (MDSAP). Two documents, this document IMDRF MDSAP WG N3 –

“Requirements for Medical Device Auditing Organizations for Regulatory Authority

Recognition” and IMDRF MDSAP WG N4 – “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

IMDRF MDSAP WG N6 - “Regulatory Authority Assessor Competence and Training

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 N11 will define a method to “grade” nonconformities

resulting from a Regulatory Authority assessment of an Auditing Organization and to document

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

This collection of IMDRF 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 perform regulatory audits and other related functions.

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 of regulatory systems,

where possible. It seeks 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 Auditing Organizations 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 define the requirements for medical device Auditing

Organizations performing regulatory audits and other related functions. Both the audit process

and the conclusions made by an Auditing Organization are subject to further review by the

applicable Regulatory Authority in the countries and regions where the medical device is

manufactured and/or placed on the market.

1.0 Scope

In the past, various Regulatory Authorities have identified shortcomings in the standards being

utilized for the recognition of organizations that conduct medical device audits for regulatory

9 December 2013 Page 4 of 25

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