康泰医学收美监管警告信，或影响美国市场经营

Core Viewpoint - 康泰医学 received a warning letter from the FDA regarding non-compliance with medical device quality system regulations for products exported to the U.S., which may impact its operations in the U.S. market [1][2] Company Summary - The warning letter was based on an FDA inspection conducted from June 9 to June 12, which identified multiple compliance issues related to production, packaging, storage, and installation of medical devices [2] - 康泰医学's U.S. market sales were approximately 114 million yuan in 2024, accounting for 23.8% of total revenue, with sales of 41.89 million yuan in the first half of the year, representing 19.26% of total revenue [3] - The company has 24 FDA-certified products and 3 products under registration, but the warning letter means a potential "window of inactivity" for its U.S. business until compliance issues are resolved [3] - In 2024, 康泰医学's revenue decreased by 35.76% to 480 million yuan, with a net loss of 77.9 million yuan, indicating that any impact on U.S. operations could exacerbate financial difficulties [4] Industry Summary - The frequency of FDA warning letters has increased, indicating rising compliance challenges for domestic medical device companies entering international markets [5][6] - In the 2024 fiscal year, the FDA issued 190 warning letters to drug and biological product manufacturers, up from 94 in 2023 and 74 in 2022, highlighting a trend of increasing regulatory scrutiny [5] - The issuance of warning letters can restrict product entry into the U.S. market and may affect the reputation of companies, leading to decreased confidence from U.S. customers and partners [6][7] - Frequent warning letters may compel Chinese pharmaceutical and medical device companies to enhance compliance management and quality systems, but could also harm the overall image of Chinese products in international markets [7]