Guidance Documents for Medical Devices
Prequalification guidance documents relating to medical devices are intended to help assist MD manufacturers understand the requirements for WHO prequalification assessment and/or procurement by WHO and other UN agencies. They should be consulted together with relevant Technical Specifications Series and Technical Report Series annexes
- WHO’s prequalification procedure for medical devices (PQDx 464)
- Prequalification Fees for medical devices (PQDx 471)
- WHO’s abridged prequalification assessment for medical devices (PQDx_470)
- Eligibility criteria for WHO’s prequalification assessment of medical devices (PQDx 465)
- Pre-submission form for WHO’s prequalification assessment of medical devices (PQDx_466)
- Instructions for completion of the pre-submission form for WHO’s prequalification assessment of medical devices (PQDx_467)
- Instructions for compilation of a medical device product dossier (non-in vitro diagnostic) for WHO’s prequalification (PQDx_468)
- Product dossier checklist for WHO's prequalification of medical devices. Geneva: World Health Organization (PQDx_469)
- Reportable changes to a WHO Prequalified and Emergency Use Listed IVD & non-IVD Medical Devices (PQDx_121) (to be posted soon)
- Instructions for submitting an application in ePQS: ExternalGuidance_SubmittingProductDossier_IVD.pdf
- Framework for clinical evaluation of devices for male circumcision. World Health Organization; 2012.
- Instructions Screening of tuberculosis using computer aided detection software (Technical specifications series for submission to WHO prequalification - medical device assessment, TSS/MDV-01)
- WHO Technical Report Series, No. 1025, 2022
- Annex 10 World Health Organization/United Nations Population Fund technical specifications for male latex condoms.
- WHO Technical Report Series, No. 1044, 2022
- Annex 9 WHO/UNFPA guidance on natural rubber latex male condom stability studies.
- Annex 10 WHO/UNFPA technical specification for TCu380A intrauterine device.
- WHO Technical Report Series, No. 1052, 2024
- Annex 5 WHO/UNFPA female condom generic specification.
- WHO Technical Report Series, No. 1067, 2025
- Annex 6 World Health Organization/United Nations Population Fund specifications for personal lubricants
Applicants may also find it useful to consult:
- Global Harmonization Task Force archived documents
- International Organization for Standardization standards
- International Medical Device Regulators Forum documents
- International Electrotechnical commission (IEC) International standards