August 15, 2025 - The themed conference "GMP and AI Foundation: Driving Efficiency Gains and Profit Leap for Medical Device Digital-Intelligent Transformation," hosted by authoritative institutions including the Medical Device Industry Sub-Alliance of the Ministry of Industry and Information Technology (MIIT) Smart Manufacturing System Solutions Supplier Alliance, was successfully held in Hangzhou. Anji Wande Medical Products Co., Ltd. (hereinafter referred to as "Wande Medical"), as a member of the Zhejiang Provincial Industry Association, was honored to be invited to attend this summit. We engaged with industry experts and peers to discuss the challenges and solutions for medical device enterprises under the dual drivers of policy and market.

**Summit Focus: Opportunities and Hidden Worries of the Golden Decade**

Data shared at the conference was inspiring: China's medical device market size is expected to exceed RMB 2.2 trillion by 2030, with accelerated import substitution, faster approval for innovation, and product globalization serving as core growth engines. However, presentations also revealed severe challenges behind the prosperity: price competition brought by volume-based procurement (VBP), continuously rising R&D and compliance costs, increasingly stringent global regulations (such as the FDA's "zero-prior-notice" unannounced inspections), and the technological gap that needs to be narrowed. An in-depth analysis of corporate cost structures pointed out that hidden costs (quality management, compliance, supply chain, etc.), accounting for up to 25%, are becoming a key variable for corporate profitability, and this is precisely where digital-intelligent technologies can play a significant role.

**Regulatory Trends: Compliance is the Foundation, Informatization is the Necessary Path**

The interpretation of regulatory trends at the conference provided clear direction for us. The clauses in the new version of the "Medical Device Production Quality Management Guīfàn (Revised Draft for Comments)" have increased significantly by 56%, and it explicitly includes detailed requirements for electronic records, informatization management, and software validation for the first time. This made us deeply realize that building a digital production quality management system that meets data integrity and traceability requirements has transformed from an "optional efficiency enhancer" to a "mandatory requirement for compliant survival." This has important guiding significance for Wande Medical to continuously improve quality management levels and ensure product safety and effectiveness.

**Wande Medical's Thoughts and Prospects: Driving Lean Production with Digital-Intelligent Transformation**

Through the learning and exchanges at this conference, Wande Medical is more determined than ever regarding the strategic direction of enhancing core competitiveness through digital-intelligent transformation. In the future, we will actively use the MIIT Smart Manufacturing Capability Maturity Model as a "navigation blueprint" to scientifically plan our own digital transformation path. We will focus on how to compress hidden operational costs and optimize every link from material management to production execution and quality control by introducing advanced information management systems, thereby achieving lean production and calmly addressing the pressures of VBP price reductions and rising costs.

This trip to Hangzhou was highly rewarding. Wande Medical will continue to pay attention to cutting-edge industry trends, actively absorb industry wisdom from events like this summit, integrate advanced concepts and technologies with our production practices, and remain committed to providing higher quality and more efficient medical device products to the market, navigating steadily and going far in the tide of the times.