International Medical Device Regulators Forum

The International Medical Device Regulators Forum (IMDRF) was conceived in February 2011 as a forum to discuss future directions in medical device regulatory harmonization.

It is a voluntary group of medical device regulators from around the world who have come together to build on the strong foundational work of the Global Harmonization Task Force on Medical Devices (GHTF), and to accelerate international medical device regulatory harmonization and convergence.

http://www.imdrf.org/index.asp

WHO | Technical guidance series for WHO prequalification of IVDs

Technical guidance series for WHO prequalification of IVDs

TGS 1 Standards applicable to the WHO Prequalification of in vitro diagnostic medical devices: TGS 1 identifies standards and guidance that contains valuable information on a range of issues that are encountered in the manufacture, verification, and validation of IVDs.

TGS 2 Establishing stability of in vitro diagnostic medical devices: TGS-2 provides IVD manufacturers with guidance on possible approaches to determine stability. More specifically it describes the requirements for WHO Prequalification in terms of stability testing.

Annex to TGS 2 Establishing component stability for in vitro diagnostic medical devices. This document provides recommendations for establishing the stability of components for IVDs. More specifically emphasis and examples are provided on the change from establishing stability for multi use dropper bottles to that for single-use vials.

TGS 3 Principles of performance studies: TGS 3 identifies the key principles that apply when conducting and reporting the study design, results, and conclusion of analytical and clinical performance studies that support performance claims for IVDs undergoing assessment for WHO Prequalification.

TGS 4 Test method validation for in vitro diagnostic medical devices: TGS 4 is intended to provide guidance to manufacturers on the validation of the test methods used in establishing the design, the development and manufacturing of an IVD.

TGS 5 Designing instructions for use for in vitro diagnostic medical devices: The instructions for use (IFU) provide the manufacturer the opportunity to directly interact with the end user and inform them about their product. TGS 5 is intended to provide guidance to manufacturers on best practice when designing the IFU.

TGS 6 Panels for quality assurance and quality control of in vitro diagnostic medical devices: The purpose of this document is to provide IVD manufacturers with guidance on possible approaches in preparing validation panels for quality assurance (QA) and quality control (QC). This document describes the expectations of WHO Prequalification in terms of the QA and QC information provided for prequalification assessment.

TGS 7 Risk management for manufacturers of in vitro diagnostic medical devices is developed to aid manufacturers of IVDs to develop appropriate risk management within their quality management system prior to compiling a product dossier for submission to WHO and in preparation for the site inspection aspect of the WHO Prequalification assessment.
— 在以下网站上阅读： www.who.int/diagnostics_laboratory/guidance/technical_guidance_series/en/