UNFPA only procures from prequalified female condom suppliers. The UNFPA Female Condom Prequalification Scheme is integrated with the WHO/RHR Technical Review Process. The first Technical Review Committee for Female Condoms was held in 2006 and reviewed several designs of the female condom. The FC2, the second generation female condom by the Female Health Company, was the only one at the time to be recommended for public sector procurement. The Technical Review Process established the criteria for the product and production processes to be adequately documented and for demonstrating the safety and efficacy of the product. The detailed report from this meeting outlines the Technical Review Process and the members of the Technical Review Committee.
The prequalification process entails that the product has been approved by the WHO/RHR Technical Review Committee. A fully prequalified product means that the manufacturing site has been inspected and independent testing of the factory’s product has been successfully completed. UNFPA ensures that the manufacturer meets the minimum requirements detailed in the relevant ISO standards, including ISO 25841: 2011 and the detailed prequalification procedures outlined in the WHO/UNFPA Female Condom: Generic Specification, Prequalification and Guidelines for Procurement, 2012 (also available in French).
There are several new designs of female condom products in various stages of development that are expected to progress in the review processes in the future. UNFPA maintains a list of prequalified female condom manufacturers and sites that have successfully completed the WHO/UNFPA prequalification process and been approved by the WHO/RHR Technical Review Committee. The Cupid female condom became the second female condom design to successfully complete the prequalification process in July 2012. The list is updated when new products become prequalified due to the on-going quality monitoring of manufacturers who are still undergoing review. Therefore, we strongly urge you to visit the site regularly.
*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