IMDRF/GRRP WG/N59FINAL:2020 Requirements for Regulatory Authority Recognition of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews - PDF (730kb)

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Requirements for Regulatory Authority Recognition of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews - PDF (730kb)[附网盘链接]由IMDRF GRRP Working Group于18 March 2020发布，适用于全球范围。

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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, this document IMDRF GRRP WG

N59 – Requirements for Medical Device Conformity Assessment Bodies for Regulatory Authority

Recognition and IMDRF GRRP WG N40 – Competence, Training, and Conduct Requirements

for Regulatory Reviewers, 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. Conformity Assessment Body (CAB) personnel should have appropriate

education, training, skills, technical knowledge, qualifications, and experience to perform

regulatory reviews for the medical device type(s) their organization is recognized to review as

outlined in IMDRF GRRP WG N40. Additional assessment and recognition documents specific

to marketing review will be developed to further support the current document.

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.

In addition to the documents focused on the recognition process and competencies, several

technical documents provide the foundational requirements for assessing marketing submissions

for medical devices. These documents include IMDRF GRRP WG/N47 Essential Principles of

Safety and Performance of Medical Devices and IVD Medical Devices and IMDRF GRRP

WG/N52 Principles of Labeling for Medical Devices and IVD Medical Devices. Additional

documents that support the regulatory review process include IMDRF Standards WG/N51

Optimizing Standards for Regulatory Use, as well as Global Harmonization Task Force (GHTF)

documents GHTF SG1/N077: 2012 Principles of Medical Device Classification, GHTF

SG1/N045: 2008 Principles of In Vitro Diagnostic (IVD) Medical Device Classification, GHTF

SG1/N078: 2012 Principles of Conformity Assessment for Medical Devices, and GHTF

SG1/N046: 2008 Conformity Assessment for In Vitro Diagnostic (IVD) Medical Devices.

IMDRF and GHTF 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 define the requirements for CABs performing regulatory

reviews and other related functions for medical devices, including IVD medical devices. Both

the regulatory review process and the decisions made by a CAB may be 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.

18 March 2020 Page 4 of 26

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