Global Business Status | |
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1. Selected for the Korea Health Industry Development Institute's [2025 Medical Device Company Market Entry Support Project]. This support covers cybersecurity testing costs, which are among the strengthened certification requirements of various countries, including the FDA, CE MDR, and Japan's PMDA. Cybersecurity audits for Anyfusion cylinder pumps cost approximately 30-40 million won. Biochemical safety testing for disposable cylinder cartridges costs approximately 70-80 million won. Testing costs and the strengthened CE MDR certification review cost approximately 100 million won. The total certification cost of approximately 200 million won is nearly ten times the previous cost. The significant investment in obtaining certification and entering the market has made it impossible for domestic medical device companies to compete with high-quality and technologically advanced Chinese products, which offer identical products. Consequently, many companies are opting out of government subsidies. Competitiveness against Chinese products remains the same across all Korean industries and the global market. Therefore, government support programs appear to be focusing more on first-mover products with greater competitiveness and potential than on fast-followers. 2. We signed an NDA (Non-Disclosure Agreement) with Company M, the largest pump vendor in China. Recognizing the potential and marketability of Anyfusion technology, we proposed a win-win scenario for both companies: joint development of unmet needs products, OEM production, and collaboration in the global market. We will carefully consider the matter, prioritizing long-term growth and profit for the company. We will also consider entering the European market. 3. We have also decided to work with an Australian consulting firm to select a partner for Australia and New Zealand (Oceania). 4. We are also selecting partners for Japan and Malaysia. 5. We will use the Anyfusion-specific rack, optimized for pendant systems in single-bed glass-partitioned intensive care units. Due to limitations in the original technology of existing pumps when infusing medications with multiple pumps, the ICU at Cheonan S University has decided to use Anyfusion's unique effectiveness in preventing unsafe infusions due to backflow. K University's ICU, which is newly setting up a pendant system, has also decided to use it as a reference. S University has decided to begin clinical trials next week. Thank you. |
Next | The Result of the Korean Governmental Supporting Project |
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