The approval marks a critical step forward in expanding options for women seeking to protect themselves from pregnancy and sexually transmitted infections, including HIV, the developers said.
The Woman's Condom, known in China as O'lavie, was jointly developed by the Program for Appropriate Technology in Health, known as PATH, the Conrad N. Hilton Foundation, and local research partners through a user-centered process across four countries.
"This milestone is a testament to the power of cross-sector collaboration," Steve Davis, PATH's president, said about last week's approval.
In 2008, PATH transferred production of the condom to Dahua Medical Apparatus Corp of Shanghai.
"As the manufacturer, we are honored that more women and men across the world may have expanded access to this new tool," said Chen Hua, the company's president.
Prequalification serves as an endorsement of quality, efficacy and safety. It allows United Nations agencies and other international purchasers to procure the product for public-sector distribution.
"The Woman's Condom has great potential to address unmet need and improve reproductive health for women, men, and young people," said Mags Beksinska, research director at Maternal, Adolescent and Child Health in South Africa. "Our recent market studies in South Africa showed that women and men, especially young people, are excited about this innovative and pleasurable female condom."
In 2014, there were 2 million new HIV infections globally, according to WHO. Women account for slightly more than half of all people living with HIV in low-and middle-income countries.
An estimated 225 million women worldwide want to avoid pregnant, but are not using modern contraception, primarily because they want methods that do not have side effects and can be used only when needed, officials said.
