GHTF In Vitro Diagnostic Medical Device Market Authorization Table of Contents (IVD MA ToC) - PDF (1.86Mb)

标准简介

In Vitro Diagnostic Medical Device Market Authorization Table of Contents (IVD MA ToC) - PDF (1.86Mb)[附网盘链接]是GHTF于不久之前发布的GHTF标准，适用于世界范围。

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标准部分原文

The document herein was produced by the International Medical Device Regulators Forum (IMDRF), a voluntary group of global medical

device regulators from around the world. The document has been subject to consultation throughout its development.

There are no restrictions on the reproduction, distribution or use of this document; however, incorporation of this document, in part or in

whole, into any other document, or its translation into languages other than English, does not convey or represent an endorsement of any kind

by the International Medical Device Regulators Forum. It is also worth noting that it is the intent of IMDRF is to continue to monitor use of

this structure and work to continually improve the documents.

INTRODUCTION

The Regulated Product Submission (RPS) proposal was endorsed as a New Work Item (NWI) by IMDRF at its inaugural meeting in

Singapore (March 2012). The proposal, as endorsed, included the objective of establishing a comprehensive harmonized structure for

premarket medical device submissions.

This document provides an internationally harmonized, modular, format for use when filing medical device submissions to regulatory

authorities for market authorization. This document is comprehensive in scope in that it defines 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.

This ToC document has been developed with consideration of public comments and experience gained from the pilot testing of the draft ToC

version.

The ToC 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 release of the first version of the final ToC document makes available harmonized formats for use in filing IVD medical device

submissions for market authorization.

IMDRF will monitor the use of these structures and work to continually improve the documents at appropriate intervals based on sufficient

use and experience. Comments or questions associated with these documents will be accepted in the prescribed format (Feedback form -

excel spreadsheet) and can be submitted to imdrftoc@gmail.com with the following subject line: IMDRF IVD ToC MA Feedback.

SCOPE

This document was developed for in-vitro diagnostics medical device (IVD) market authorization submissions. Market authorization

submissions for combination products are out of scope; refer to each specific regulator for guidance regarding combination products.

Submissions to request approval to conduct clinical trials are not within the scope of this document.

The document is intended to provide guidance for industry with flexibility to adapt to the variety of products and future products.

PURPOSE

To create a comprehensive submission structure that can be used as a harmonized international electronic submission format while

minimizing regional divergences and indicating where regional variation exists. This document is intended to provide guidance regarding the

location of submission elements. This document is intended to work together with a separate document created for each participating

jurisdiction - a classification matrix.

This document is not intended to introduce any new regulatory requirements; however, by virtue of being more transparent, it may appear to

be introducing new requirements.

CLASSIFICATION MATRICES

As this document is comprehensive in nature, not all headings are required for all submission types and/or jurisdictions. This

document is 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 to be made available on regional regulators websites.

DEFINITIONS

F ull R eport - Typically includes a complete, detailed description of the objective of the assessment, the methods and procedures including

when applicable why a regional or harmonized/recognized standard/guidance has or has not been complied with, study endpoint(s), pre­

defined pass/fail criteria, deviations, results, discussion and conclusions, and may include data. Complete, detailed support of method

selection, worst case justification, study endpoint selection, and pass/fail criteria should be included.

S ummary- A summary should include a brief synopsis of the (1) purpose, (2) methods, (3) acceptance criteria, (4) results and (5) discussion

and conclusions. Outliers and deviations should be reported with the results. Results should be stated quantitatively with appropriate

statistical context where applicable (e.g. value ± SD, confidence intervals, etc.).

The summary should specifically address:

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