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IMDRF/GRRP WG/N66FINAL:2021 Assessment and Decision Process for the Recognition of a Conformity Assessment Body Conducting Medical Device Regulatory Reviews - PDF (1.2Mb)

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Assessment and Decision Process for the Recognition of a Conformity Assessment Body Conducting Medical Device Regulatory Reviews - PDF (1.2Mb)[附网盘链接]是IMDRF Good Regulatory Review Practices Working发布的GHTF标准，适用于全球。

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Assessment and Decision Process for the Recognition of a Conformity Assessment Body Conducting Medical Device Regulatory Reviews - PDF (1.2Mb)[附网盘链接]
Assessment and Decision Process for the Recognition of a Conformity Assessment Body Conducting Medical Device Regulatory Reviews - PDF (1.2Mb)[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 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 N40 and N59 are focused on requirements

for Conformity Assessment Bodies (CABs) 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 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.

The purpose of this document, IMDRF GRRP WG/N66 - Assessment and Decision Process

for the Recognition of a Conformity Assessment Body Conducting Medical Device Regulatory

Reviews, is to explain the assessment process and outcomes, including the method to “grade

and manage” nonconformities resulting from a recognizing Regulatory Authority’s

assessment of a CAB; and to document the decision process for recognizing a CAB or

cessation of recognition. To prevent confusion between marketing review activities

performed by a CAB and the activities performed by medical device Regulatory Authority

Assessors for CAB recognition and surveillance, in this document, the latter are designated as

“assessments.”

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, determination, or accreditation.

IMDRF developed these GRRP 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.

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[24 June 2021] Page 4 of 34

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