WHO announces expansion of prequalification programme for medical devices

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World Health Organization news release

The World Health Organization (WHO) announced a major expansion of its prequalification programme to include a wider range of life-saving medical devices such as contraceptives and innovative TB screening technologies. This broadens the range of quality-assured, safe and effective products covered by the programme, which already includes in vitro diagnostics (medical tests) and male circumcision devices.

The WHO prequalification programme helps ensure that essential health products meet international quality, safety and performance standards for global procurement. Medical devices are assessed through an independent, standardized and transparent process. Products that meet the required standards are included in the WHO list of prequalified medical devices, providing trusted guidance for United Nations agencies, procurement organizations, donors and national authorities.

The expansion is particularly significant for countries with limited regulatory capacity. An estimated 70% of countries report inadequate or weak regulatory systems for medicines and vaccines, with even greater challenges for other health products. By expanding the programme, WHO will help countries improve access to quality-assured medical devices such as male and female condoms, intrauterine devices (IUDs), computer-aided detection software for TB (CAD-TB) screening and male circumcision devices.

Read the full news release here.

 

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