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(2019; 22 pages)
World Health Organization (WHO) prequalification of male circumcision devices (MCDs) is coordinated through the department of Essential Medicines and Health Products. Focus is placed on Male Circumcision Devices for their potential to accelerate delivery of male circumcision programmes in high HIV incidence settings and, thereby, contribute to reducing the risk of HIV infection in adult male populations.
WHO prequalification of Male Circumcision Devices is a comprehensive quality assessment of individual MCDs through a standardized procedure aimed at determining whether the product meets WHO prequalification requirements.
The prequalification assessment process for MCDs includes the following components:
- review of the application form;
- review of the product dossier, including review of clinical evidence;
- inspection of the manufacturing site(s); and
- labelling review.
Products submitted for prequalification assessment that meet, as determined by WHO, the WHO prequalification requirements are included in the WHO list of prequalified MCDs. The duration of the validity of the prequalification status of a product is dependent on the manufacturer’s fulfilment, within the applicable deadlines, of its post-qualification obligations and requirements, including:
- prequalification commitments;
- annual reporting;
- reporting of changes;
- post-market surveillance obligations;
- receiving re-inspections; and
- ongoing compliance with WHO prequalification technical specifications, as applicable.
The findings of WHO prequalification are used to assess the safety, quality and performance of commercially available MCDs for the purpose of providing guidance to interested United Nations (UN) agencies and WHO Member States in their procurement decisions.
This document has been prepared to provide manufacturers with an overview of the WHO process for prequalification assessment of MCDs (the prequalification assessment process). Manufacturers wishing to apply for WHO prequalification of their product(s) should read this document before applying, so that they can be aware of and prepared for all stages of the prequalification assessment process.