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Regulatory approvals

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The Woman’s Condom (branded as O’LavieTM in China) is approved for sale in Europe and China; it holds the CE Mark (2010) and Shanghai Food and Drug Administration approval (2011). In May 2013, the Woman’s Condom received the South African Bureau of Standards (SABS) certification mark. The product is expected to become available in South Africa and select African countries soon.   

In addition, the Woman’s Condom is currently under review by a technical committee with members from the World Health Organization (WHO) and the United Nations Population Fund. The committee’s approval would lead to WHO prequalification of the product.

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