FDA一纸警告信，揭开了康泰医学的合规危机与出海困局

Core Viewpoint - The warning letter from the FDA has highlighted compliance issues for Kangtai Medical, reflecting the broader challenges faced by Chinese medical device companies in maintaining market access in the U.S. [1] Group 1: Market Access and Revenue Impact - The U.S. market is a significant revenue source for Kangtai Medical, contributing 114 million yuan in 2024, accounting for 23.84% of total revenue, and 19.26% in the first half of 2025 [2] - The FDA's "refusal of entry" measure is not a permanent ban, but until the warning letter is resolved, Kangtai's products cannot enter the U.S. market, with typical remediation periods ranging from 3 to 12 months [2] - Prolonged remediation could lead to a direct decline in revenue for 2025 and potential loss of long-term U.S. distributors, as clients may not wait for compliance issues to be resolved [2] Group 2: Compliance System Weakness - Kangtai Medical's rapid expansion during the pandemic with products like pulse oximeters and monitors has outpaced its internal compliance management [3] - The FDA's 21 CFR Part 820 regulations cover the entire production chain, and any lapse in compliance can trigger warnings, yet Kangtai has not disclosed specific violations or remediation plans [3] Group 3: High Remediation Costs - In addition to market losses, Kangtai must invest significant resources in remediation, including hiring compliance consultants and upgrading production processes, which increases financial and operational pressure [4] - Balancing compliance investments with short-term profitability will be a critical challenge for management, as mismanagement could impact current operations and long-term competitiveness [4] Group 4: Industry-Wide Issues - Kangtai Medical is not alone; the frequency of FDA warning letters has increased for Chinese medical device companies, indicating a common risk in maintaining compliance after initial market entry [5] - The dynamic nature of FDA oversight means that companies may face escalating penalties, from warning letters to potential loss of registration, if compliance is not continuously prioritized [5] - The FDA's scrutiny is also extending to clinical trials and research institutions, as seen with other companies facing compliance issues [5] Conclusion - The incident serves as a warning for Chinese medical device companies that market expansion requires ongoing compliance management, which should be integrated into core business operations rather than treated as a one-time requirement [6]