Prequalification of Medical Devices
WHO prequalification of medical devices is coordinated by the Assessment of Medical Devices Team in the Prequalification Unit. WHO prequalification of male circumcision devices (MCDs) began in 2011–2012 to increase access to quality-assured male circumcision as a priority intervention in countries and settings with a high incidence of HIV and a low prevalence of male circumcision. This activity operated alongside WHO’s prequalification of IVD assessment procedure to support HIV prevention efforts.
In 2026, WHO expanded the scope of eligible medical devices to include the pilot assessment of: computer-aided detection (CAD) software for tuberculosis screening, male latex condoms, female condoms, and copper-bearing intrauterine devices (Cu-IUDs). These products are in addition to MCDs.
As part of this expansion, WHO is centralizing prequalification assessment of male condoms, female condoms, and IUDs — activities previously coordinated in collaboration with the United Nations Population Fund (UNFPA) — within the WHO Prequalification Unit.
For all questions related to prequalification of medical devices: contact diagnostics@who.int.
Medical devices eligible for Prequalification
The following medical device types are currently eligible for WHO prequalification assessment:
| Medical Device | Eligibility criteria | Additional notes |
|---|---|---|
| Male latex condoms | Manufacturers must undertake the processes of formulation, compounding and dipping, lubrication, and testing. Manufacturers using pre-vulcanized latex must undertake the final assembly, testing and packaging of the finished product at a minimum | Agents, distributors or suppliers engaged only in testing, lubricating and primary packaging of reproductive health devices are not eligible to apply. |
| Female condoms | Manufacturers must undertake the processes of formulation, compounding and dipping, lubrication, and testing. Manufacturers must undertake the formation of the sheath, testing and packaging at a minimum. | |
| Copper-bearing intra-uterine devices | Manufacturers must undertake the process of moulding, assembly, packaging and control of sterilization. | One or more of these processes may be carried out on a contract basis but the manufacturer retains overall responsibility for product quality |
| CAD-TB medical devices | Intended to be used in place of human readers for interpreting digital chest X-rays for screening and triage for TB disease | Products must be endorsed through policy assessment by WHO Department for HIV, TB, Hepatitis, and Sexually Transmitted Infections (HTH) (previously Global TB programme) |
| Male circumcision devices | As an intervention for the prevention of HIV in countries and settings with a high incidence of HIV and a low prevalence of male circumcision. | Clinical studies must have been presented to the WHO Department for HIV, TB, Hepatitis, and Sexually Transmitted Infections (HTH) Technical Advisory Group on Innovations in Male Circumcision (TAG IMC) for their review and the TAG IMC issued a positive recommendation. |
Manufacturers of other medical device types should contact WHO at diagnostics@who.int to enquire about future eligibility. Eligibility does not guarantee acceptance of an application; WHO will confirm eligibility following review of the pre-submission form.