Technologies for Reproductive Health

Woman’s Condom commercial partner

Shanghai Dahua Medical Apparatus Company

Statue in front of Dahua facility in Shanghai, China

The Shanghai Dahua Medical Apparatus Company manufacturing facility. Photo: PATH/Min Ji.

Dahua Medical Apparatus Company (Dahua) of Shanghai, China, is a high-quality, large-volume manufacturer with more than 25 years of experience in the medical device business. Dahua has specific capability in film production and welding, plastics molding, and assembly. The company is compliant with general medical device good manufacturing practices (GMP) and has ISO 9000 series and ISO 13485 registration.

In 2008, PATH licensed Dahua to manufacture and distribute the Woman’s Condom. Since then, Dahua has worked on production scale-up and preparation for regulatory approvals. Dahua received South Africa Bureau of Standards certification marking (2013), Shanghai Food and Drug Administration (2011) and CE Mark approval (2010) for the Woman’s Condom, which allows for distribution and marketing in South Africa, China, and Europe, respectively. In March 2011, Dahua submitted a dossier to the World Health Organization (WHO)/United Nations Population Fund Technical Review Committee. The committee’s approval could lead to WHO prequalification of the Woman’s Condom, which would open the door to bulk public-sector purchase by United Nations agencies.

Through their Protection Options for Women product development partnership, PATH and Dahua aim to make the Woman’s Condom available at an affordable price in both the public and private sectors. PATH and Dahua will focus first on developing markets in China and sub-Saharan Africa with the eventual goal of raising awareness and building demand about the Woman’s Condom worldwide.

Websites

Dahua company website: www.dahuachina.com.cn

O’LavieTM* female condom website: www.femalecondom.cn

*O’Lavie is a trademark of Shanghai Dahua Medical Apparatus Company.