Medical devices eligible for Prequalification
The following medical device types are currently eligible for WHO prequalification assessment:
Table updated 25 September 2026
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 If lubricants are part of the application, they must have regulatory approval from a recognized regulatory authority (RRA) listed* | Agents, distributors or suppliers engaged only in testing, lubricating and primary packaging of reproductive health devices are not eligible to apply. *Refer to the document “WHO’s abridged prequalification assessment for medical devices” for the full list of RRAs. |
| 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. If lubricants are part of the application, they must have regulatory approval from a recognized regulatory authority (RRA) listed* | *Refer to the document “WHO’s abridged prequalification assessment for medical devices” for the full list of RRAs |
| 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. |
Note that based on the volume of applications, the products below will receive priority consideration during the initial assessment wave.
- Products previously submitted to the UNFPA, together with CAD-TB products and male circumcision devices, will be eligible for WHO assessment beginning 1 October 2026.
- Contraceptive devices not previously submitted to and accepted by UNFPA will be eligible for WHO assessment beginning 1 April 2027.
- Applications for changes to contraceptive devices currently listed by UNFPA may be submitted to WHO from 1 October 2026 onward.
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.