New prequalification programme aims to improve access to safe contraceptives and AI-powered tuberculosis screening technologies, particularly in countries with weak regulatory systems.
By Bunmi Yekini
The World Health Organization (WHO) has expanded its medical device prequalification programme to cover contraceptives and artificial intelligence-powered tuberculosis screening technologies, in a move to improve access to quality-assured health products.
The expansion, announced on Friday, also brings male circumcision devices under the programme’s broader assessment framework, which previously covered mainly medical tests and selected devices.
The programme independently assesses medical devices against international standards for quality, safety and performance, providing guidance for United Nations agencies, donors, procurement organisations and national health authorities.
WHO said the expansion was particularly important for countries with limited regulatory capacity, noting that an estimated 70% of countries have inadequate or weak regulatory systems for medicines and vaccines, with even greater challenges in regulating other health products.
The expanded programme will cover male and female condoms, intrauterine devices (IUDs), computer-aided detection software for tuberculosis screening and male circumcision devices.
WHO Chief Scientist and Assistant Director-General for Health Systems, Access and Data, Dr Sylvie Briand, said the expansion would strengthen confidence in essential medical products and help countries improve equitable access to healthcare technologies.
A key component of the initiative is the transfer of prequalification for male and female condoms and IUDs from the United Nations Population Fund (UNFPA) to WHO.
The agency said access to quality-assured contraceptives was essential for preventing unintended pregnancies and supporting informed family planning decisions. Condoms also remain an important tool for preventing HIV and other sexually transmitted infections.
Male circumcision devices have also been incorporated into the broader framework, replacing their previous separate assessment process. WHO-prequalified devices support voluntary medical male circumcision services, which can reduce men’s risk of acquiring HIV through heterosexual exposure by about 60%.
The expansion also introduces computer-aided detection software for tuberculosis screening into the programme, marking the inclusion of a digital health technology.
The software uses artificial intelligence to analyse digital chest X-rays and identify people who may have tuberculosis and require further testing.
WHO said the technology could help countries with high TB burdens improve early detection and link patients more quickly to diagnosis and treatment.
The agency said the expanded programme would provide countries and procurement organisations with a reliable basis for identifying medical devices that meet international quality and safety standards, particularly where national regulatory oversight remains limited.