GHTF Points to consider in the use of the IMDRF Table of Content for Medical Device Submissions pre-RPS - PDF (153Kb)

标准简介

Points to consider in the use of the IMDRF Table of Content for Medical Device Submissions pre-RPS - PDF (153Kb)[附网盘链接]由GHTF于过去发布，适用于全球。

标准截图

 

标准文档说明

标准文档类型为Points to consider in the use of the IMDRF Table of Content for Medical Device Submissions pre-RPS - PDF (153Kb)[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

1.0 Introduction

The IMDRF first final version of the In Vitro Diagnostic Medical Device Market Authorization

Table of Contents (IVD MA ToC) and Non-In Vitro Diagnostic Medical Device Market

Authorization Table of Contents (nIVD MA ToC) are now available on www.imdrf.org.

The release of the first version of the final ToC documents makes available harmonized formats

for use in filing IVD and nIVD medical device submissions for market authorization.

These documents provide internationally harmonized, modular, format for use when filing

medical device submissions to regulatory authorities for market authorization. The Table of

Contents documents are comprehensive in scope in that they define the location of both common

(IMDRF) and regional content for all submission types. As a consequence, not all headings are

required for all submission types and/or IMDRF jurisdictions. As such, these documents are

intended to work together with a separate document created for each participating jurisdiction – a

classification matrix. The classification matrix defines whether for the given submissions type a

heading is required, not required, optional, conditionally required, etc. The classification

matrices are the published under the authority of participating authorities and are not products of

IMDRF, please consult regional regulator websites for further information.

The ToC documents were designed for eventual use in an electronic submission environment,

defining the location and format of submission content that would be assembled and displayed

by software tools for each participating IMDRF jurisdiction based on the classification matrices.

It is anticipated that the Health Level Seven (HL7) Regulated Product Submission (RPS)

electronic exchange standard, once final and recognized, will serve as the international standard

for health product submissions, including medical devices and pharmaceutical for human use.

This will permit the development of RPS compliant software tools. In the interim, the IMDRF

RPS working group intends to provide recommendations on the filing of electronic copies of

medical device submissions in the IMDRF ToC formats.

IMDRF recognizes that continued piloting, adequate training and additional guidance will be

important to the successful adoption and use of the new ToC formats. To this end, IMDRF has

produced this Points to Consider document, which will be updated, as necessary, based on

experience and feedback from stakeholders. Further documentation, including educational

material, will also be considered by IMDRF and its members to support the implementation of

the ToC formats. Please consult www.imdrf.org and regional regulator websites for the most up-

to-date information on implementation plans and requirements.

This Points to Consider document has been developed based on experience gained in piloting the

draft In Vitro Diagnostic Medical Device Market Authorization Table of Contents (IVD MA

ToC) and non-In Vitro Diagnostic Medical Device Market Authorization Table of Contents

(nIVD MA ToC). It is intended to provide clarification and guidance regarding the use of the

ToC format in a pre-Regulated Product Submission (RPS) compliant electronic environment.

Further harmonized guidance is to be developed in the near future and will elaborate on these

30 June 2014 Page 4 of 11

网盘链接

百度网盘：https://pan.baidu.com/s/1MnJOpMsumfeLvpJMix2fSg
提取码：qqi8