Regarding the recent announcement by the French regulatory authorities concerning the recall of certain condom products, which included Okamoto products, we would like to provide the following explanation to consumers.
- The recall is limited to specific products sold through specific channels.
The products sold by Okamoto in various countries and regions worldwide have each undergone the necessary registrations and approvals and comply with the quality standards and legal requirements applicable in their respective markets. The two models of the products subject to the recall are designed for Japan market only, which nevertheless entered the French market through unofficial channels outside of our authorized channels. As these products did not bear the CE mark required in Europe, the French regulatory authorities determined that they did not comply with the EU Medical Device Regulation (EU) 2017/745. All Okamoto products that we supply to France through authorized channels have been formally approved for sale in the local market as CE marked Class IIb medical devices. The recalled products mentioned above are limited to specific lots that entered the French market through unofficial channels and therefore have no connection whatsoever with Okamoto products sold through authorized channels. - All Okamoto products sold through authorized channels comply with applicable laws, regulations, and standards.
All Okamoto condom products sold globally have obtained relevant registration certificates, where applicable, and comply with the applicable requirements concerning labeling. The packaging of official products complies with appliablce local laws and regulations and typically includes the authorized agent information and the registration certificate number, where applicable.We have always been committed to fulfilling our responsibilities to the consumers worldwide. All Okamoto products undergo strict quality inspections and compliance reviews.
Regarding the recall incident in France, we will continue to follow-up on the ongoing situation and take the necessary measures as appropriate. We remain committed to delivering safe and reliable products. Your understanding and support is highly appreciated.