UNFPA manages the Male Latex Condom and IUD Prequalification Schemes for the UN system. The Prequalification Schemes were developed by WHO in 2001 with the support of UN and other partner agencies. WHO then delegated the management of this program to UNFPA in 2005. The prequalification process, in accordance with international ISO standards and WHO/UNFPA specification guidelines, entails the following:
- Response to an Expression of Interest by supplier
- Submission of required documents by supplier
- Review of submitted documents by technical experts*
- Factory inspections conducted by certified inspectors
- Sampling and testing of products by an independent laboratory
- Continuous quality control and monitoring through pre-shipment testing of every batch
- Re-qualification of manufacturers every three years.
For detailed prequalification procedures and guidance on requirements for male latex condom manufacturers, please refer to the Male Latex Condom: Specification, Prequalification and Guidelines for Procurement, 2010** (also available in Spanish and French.) For detailed prequalification procedures and guidance on requirements for IUD manufacturers, please refer to TCu380A Intrauterine Contraceptive Device (IUD): Specification, Prequalification and Guidelines for Procurement, 2010.
UNFPA maintains a list of prequalified male latex condom and IUD manufacturers and sites that have successfully completed the prequalification process. The list is updated regularly due to continuous quality monitoring of manufacturers. Therefore, we strongly urge you to visit the site regularly. If you would like to be informed when changes are made to the lists, please contact QA@unfpa.dk. You can also view this information using the following links: Prequalified male latex condom factories; Prequalified IUD manufacturers.
Quality control measures are also implemented after suppliers have been prequalified. Every batch of condoms purchased by UNFPA undergoes pre-shipment sampling and testing by ISO 17025 accredited laboratories. UNFPA only accepts and ships batches that have passed the quality control testing according to the WHO/UNFPA Male Latex Condom Specification 2010 and ISO 4074. Read more about UNFPA pre-shipment testing here: in English, in French and Spanish.
*UNFPA invites Regulatory Authorities and Ministries of Health to participate in WHO/UNFPA Prequalification Process and participate in on-site inspections. UNFPA does not have the capacity to bear the cost incurred by any such participation. For more information on how to become involved, please contact QA@unfpa.dk
**The WHO/UNFPA Male Latex Condom: Specifications, Prequalification and Guidelines for Procurement, 2010 was updated in 2013 and a corrigendum has been issued for the printed versions of the book. Please click here for the printable version of the corrigendum in English. Corrigendum is also available in French and Spanish.