国产医疗器械的时代，来了！

Core Insights - The article discusses the implementation of domestic product standards in government procurement, marking a significant shift towards prioritizing domestic products in China [2][3][42] - The new policy establishes quantifiable standards and verification mechanisms for domestic products, moving from encouragement to mandatory compliance [2][3][42] Policy Overview - The State Council issued a notification that will take effect on January 1, 2026, emphasizing the need for domestic products in government procurement [2][5] - The policy aims to enhance the resilience of the medical device supply chain and ensure national security amid global uncertainties [3][42] Domestic Product Standards - Domestic products must meet three criteria: 1. Products must undergo a transformation in China from raw materials to finished goods [9][10] 2. The cost of components produced in China must meet a specified percentage of the total product cost [9][10] 3. Key components and processes must be completed within China for certain products [9][10][11] Support for Domestic Products - Domestic products will receive a 20% price evaluation discount in government procurement, enhancing their competitiveness [12][13] - If a supplier's products meet the domestic standards, all products in a procurement package can benefit from this discount [12][13] Implementation and Compliance - Suppliers must submit a declaration confirming their products meet domestic standards, which will be crucial for participating in government procurement [25][27] - The article outlines the importance of compliance and transparency in supply chains to avoid penalties for false declarations [27][28] Strategic Implications for Companies - Foreign companies must adapt their strategies, either by localizing production or retreating to private and self-pay markets [30][31][32] - Domestic companies are encouraged to leverage the policy to expand their market share and invest in key components and technologies [34][35] Future Outlook - The next 5-10 years are seen as a critical window for companies to adjust to the new standards and enhance their competitive positions [42][44] - The policy is expected to reshape the market landscape, creating a clear divide between companies that can meet the new standards and those that cannot [44][46]