(Edition 2) Requirements for Medical Device Auditing Organizations for Regulatory Authority Recognition - PDF (621kb)

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Requirements for Medical Device Auditing Organizations for Regulatory Authority Recognition - PDF (621kb)[附网盘链接]由IMDRF MDSAP Working Group于24 March 2016发布，适用于世界范围。

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Introduction

Requirements for Medical Device Auditing Organizations for Regulatory Authority

Recognition,” originally finalized in 2013, is being republished as IMDRF/MDSAP

WG/N3FINAL:2016 (Edition 2). Edition 2 was necessary after revisions were made in ISO/IEC

17021-1:2015 which replaced ISO/IEC 17021-1:2011 normative requirements in N3 Final:2013.

The editorial revisions made to this edition can largely be categorized as: (1) re-organization of

clauses and revision to some clause titles to align with ISO/IEC 17021-1:2015; (2) deletion of

the original MDSAP provision where Auditing Organization that are Regulatory Authorities did

not have to engage a separate committee for safeguarding impartiality since the requirement for

such a committee has been eliminated in ISO/IEC 17021-1:2015; and, (3) a new exception in

clause 9.5 is added to restore the requirement in the original IMDRF MDSAP N3:2013

document due to changes in ISO/IEC 17021-1:2015 requirements, this exception will also ensure

consistency with the IMDRF Informational Document IMDRF/MDSAP WG/N29 Final:2015.

Annex A has been added to this edition to detail the specific change.

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 defines 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

24 March 2016 Page 4 of 30

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