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IMDRF/GRRP WG/N61FINAL:2020 Regulatory Authority Assessment Method for Recognition and Surveillance of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews - PDF (785kb)

赵静曼 5/3/2022 浏览 218 IMDRF/GRRP WG/N61 全球范围

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Regulatory Authority Assessment Method for Recognition and Surveillance of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews - PDF (785kb)[附网盘链接]是IMDRF GRRP Working Group发布的GHTF标准，适用于全球范围。

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Regulatory Authority Assessment Method for Recognition and Surveillance of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews - PDF (785kb)[附网盘链接]
Regulatory Authority Assessment Method for Recognition and Surveillance of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews - PDF (785kb)[附网盘链接](截图)

 

标准文档说明

标准文档类型为Regulatory Authority Assessment Method for Recognition and Surveillance of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews - PDF (785kb)[附网盘链接]高清PDF版本（文字版），标准文档内可进行搜索，可以复制原文，可粘贴。

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/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 market 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.

This document IMDRF GRRP WG/N61 – Regulatory Authority Assessment Method for

Recognition and Surveillance of Conformity Assessment Bodies Conducting Medical Device

Regulatory Reviews is focused on how Regulatory Authorities and their Assessors will evaluate

or “assess” medical device Conformity Assessment Bodies’ (CAB) compliance to the

requirements of N59 and N40.

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 surveillance 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.

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.

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.

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.”

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