Core Viewpoint - The European Union has decided to restrict Chinese companies from participating in medical device tenders exceeding 5 million euros, citing the International Procurement Instrument (IPI) as the basis for this decision. This move is perceived by China as unfair competition disguised as fair competition, and the Chinese government has vowed to protect the legitimate rights of its enterprises [1][3]. Group 1: Background and Context - The IPI was first proposed in 2012 and implemented in June 2022, allowing the EU to exclude companies from certain countries from large public tenders or impose punitive adjustments on their bids, potentially increasing them by 10%-20% [3]. - The restriction primarily affects high-end medical equipment contracts, such as proton therapy systems and advanced imaging devices, which are not common globally, including in China [6]. Group 2: Market Impact - The immediate industry reaction was one of concern, but this was quickly tempered as the actual impact of the regulation is considered limited. The majority of contracts above 40 million RMB are rare, and the EU market is largely a replacement market with limited new contracts [5][6]. - Chinese medical device companies are still in the early stages of international expansion and lack the long-term trust relationships with local public healthcare institutions that established companies like Siemens and Philips have [6]. Group 3: Historical Development of Chinese Medical Device Exports - The export journey of Chinese medical devices can be divided into three phases: 1. From the late 1990s to 2008, focusing on low-value consumables and simple diagnostic devices, with minimal technical content [7]. 2. From 2009 to 2015, where companies began to move beyond OEM and private label, increasing the export of mid-to-high-end devices [8]. 3. From 2016 to present, where there has been a significant output of low-value consumables alongside breakthroughs in high-end equipment, with a focus on localization in target markets to adapt to protectionist policies [8].