Female Condom Product Progress

 

One of the key goals of the UAFC Joint Programme and FCMi is to increase the variety of condoms available to users. Although, there are currently a range of female condoms being designed and manufactured by various producers, they are at different stages of market availability. We have broken down this process into the below three broad steps. For more details on each individual female condom, click on the product name.

Product Development product undergoing clinical testing or awaiting regulatory approval, etc but has not yet reached the market

Local Market Access product available in certain countries but not yet eligible for bulk procurement by UN or USAID agencies

Eligible for Bulk Procurement product is eligible for bulk procurement by UN or USAID agencies, i.e. WHO/UNFPA prequalified or USFDA approved

Cupid®  

100%

WHO/UNFPA prequalified since July 2012. Initiated the USFDA approval process in 2012. The product holds the CE marking and is distributed in India, Brazil, Indonesia, The Netherlands, South Africa, Mozambique and Kyryz Republic.

FC2®  

100%

Available in 143 countries and holds CE marking. WHO/UNFPA prequalified since 2007 and USFDA approved in 2009. Available in 143 countries and holds CE marking. WHO/UNFPA prequalified since 2007 and USFDA approved in 2009.

Velvet  

100%

Currently being assessed by Functionality Study II, the results of the study will be part of the product dossier to be submitted for WHO/UNFPA prequalification.

Woman's Condom  

100%

Holds South Africa Bureau of Standards (SABS) certification mark and CE mark. Is approved by the Shanghai Food and Drug Administration. Currently under review for WHO/UNFPA prequalification.

Phoenurse®  

66%

Holds CE marking.

VA w.o.w.®  

66%

Holds CE marking and is available in the private sector in several countries including South Africa, Brazil and India. Product dossier has been submitted to WHO/UNFPA for prequalification.

Cupid2®  

66%

Currently being assessed by Functionality Study II the results of the study will be part of the product dossier to be submitted for WHO/UNFPA prequalification.

OrigamI™ FC  

33%

Currently not available commercially. Expected to reach the market in late 2015, pending regulatory pre-market approvals.