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拜耳首获国产医疗器械注册证,政策助力外企加码本地生产
Bei Ke Cai Jing· 2025-06-19 09:02
Core Viewpoint - Bayer has received its first domestic medical device registration certificate for its MEDRAD Stellant D-CE high-pressure injection system and accessories, marking a significant step in localizing production in China [1][3]. Group 1: Bayer's Localization Efforts - Bayer's MEDRAD Stellant D-CE high-pressure injection system is designed for intravenous injection of contrast agents in diagnostic imaging, including CT and mammography [3]. - The registration inspection cycle for Bayer's first domestically produced medical device was shortened to 1.5 months, significantly accelerating the product's market entry [3]. - Bayer's first manufacturing facility for imaging diagnostic devices in China was established in Beijing Economic Development Zone in September 2023 [4]. Group 2: Industry Trends - Many foreign companies are increasing their local production efforts in China, with notable examples including Illumina and Terumo, which have announced plans for localized manufacturing of high-end medical devices [4]. - The Chinese medical device market has shown substantial growth, with revenues increasing from 553.2 billion yuan in 2014 to 1.31 trillion yuan in 2023, reflecting a compound annual growth rate of 10% [6]. - China is projected to become the largest medical device market globally by 2030, indicating significant future growth potential [7]. Group 3: Policy Support - Recent policies have been favorable for foreign enterprises, encouraging them to localize production of innovative pharmaceuticals and high-end medical equipment [8]. - The Chinese government has implemented measures to simplify the registration process for imported medical devices produced domestically, enhancing the ease of market entry for foreign companies [7][8]. - A proposed government procurement policy suggests a 20% price deduction for domestic products in competitive bidding, further incentivizing local production [9].