BiOptic Visits Japanese Partner for Strategic Discussions and Regulatory Milestone Achievement

We sincerely thank our partner in Japan, Otsuka Electronics Co., Ltd. for their thoughtful arrangement of this visit, which ensured smooth and productive discussions on strategic collaboration, potential customers, and refinement opportunities for Qsep Ultra.

With their invaluable support, BiOptic has successfully obtained the Registration Certificate for Foreign Medical Device Manufacturers and the Registration Certificate for Foreign In Vitro Diagnostic (IVD) Manufacturers in Japan.

We are now formally integrated into Japan’s medical device regulatory framework as a compliant manufacturer, reflecting our strengthened quality and regulatory management and providing a solid foundation for introducing our products to the Japanese market.

We would also like to extend our sincere appreciation to our long-term partner in Japan, Otsuka Electronics Co., Ltd. for their continued trust and support and for their invaluable assistance throughout the registration process, which enabled our successful certification. This milestone not only marks a significant achievement in our partnership but also paves the way for further expansion into the Japanese market.

We look forward to strengthening our collaboration with Otsuka Electronics and together delivering high-quality products to more customers. We will continue to enhance our technological capabilities and quality management systems as we steadily expand our global presence.

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