Technical Guidance Series 7 (TGS-7) for WHO Prequalification - Diagnostic Assessment: Risk Management for Manufacturers of in Vitro Diagnostic Medical Devices
(2018; 66 pages)

Abstract

The WHO Prequalification Programme is coordinated through the Department of Essential Medicines and Health Products. The aim of WHO prequalification of in vitro diagnostic medical devices (IVDs) is to promote and facilitate access to safe, appropriate and affordable IVDs of good quality in an equitable manner. Focus is placed on IVDs for priority diseases and their suitability for use in resource-limited settings. The WHO Prequalification Programme undertakes a comprehensive assessment of individual IVDs through a standardized procedure that is aligned with international best regulatory practice. It also undertakes post-qualification activities for IVDs, to ensure their ongoing compliance with prequalification requirements.

Products that are prequalified by WHO are eligible for procurement by United Nations agencies. The products are then commonly purchased for use in low- and middle-income countries.

The Technical Guidance Series (TGS) was developed following a consultation held on 10–13 March 2015 in Geneva, Switzerland. The consultation was attended by experts from national regulatory authorities, national reference laboratories and WHO prequalification dossier reviewers and inspectors. The guidance series is a result of the efforts of this and other international working groups.

This guidance is intended for manufacturers interested in WHO prequalification of their IVD. It applies in principle to all IVDs that are eligible for WHO prequalification for use in WHO Member States. This guidance should be read in conjunction with relevant international and national standards and guidance.

 
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