KEYU series of Feces Analyzers, Urine analyzers and related reagents have been approved by Thai Food and Drug Administration (TFDA). TFDA is the Thai government agency responsible for regulating and administering food and drug safety.
Medical devices are regulated by the FDA's Division of Medical Device Controls (MDCO), whose mission is to regulate and monitor health products to meet quality and efficacy requirements. This is an opportunity for KEYU to successfully develop the Southeast Asian market.
Thailand is one of the major economies in Southeast Asia and is now the second largest healthcare market in Southeast Asia, with an increasing demand for medical device applications in the market.
TFDA registration is an important entry requirement into the Thai market. Thailand, as an important market in Southeast Asia, has high market access requirements for medical devices. Through TFDA registration, KEYU can obtain approval and recognition from the Thai government and gain the right to sell and circulate in the Thai market, further expanding market share and increasing sales opportunities.
TFDA certification is of great significance to KEYU, not only is it a necessary condition to comply with the legal requirements and market access, but also enhances the credibility and competitiveness of the product and guarantees the safety and effectiveness of the product.