- Starting February 2, 2026, the U.S. Food and Drug Administration (FDA) began implementing the Quality Management System Regulation (QMSR) criteria to comply with ISO 13485. If your production lines and documentation systems are not ready today, you may not be able to enter the supply chain for the U.S. market.
- Precedence Research reports that the global medical device market was valued at US$678.88 billion in 2025 and is projected to reach US$1,209.42 billion in 2035, with a compound annual growth rate (CAGR) of 5.94% between 2026 and 2035.
- According to BMI Research, medical device exports account for 1.2% of Thailand's GDP, with an estimated growth rate of 6.2% per year between 2024 and 2029, and are expected to reach ฿109.2 billion ($2.8 billion) by 2030, driven by strong government support for the manufacturing of more sophisticated medical devices.
In the space of medical device manufacturing, the "Cost of Quality" is the dividing line between product success and failure to meet the standards of regulatory organizations. Increasingly, this trend will rise to a new level of complexity and unpredictability. |
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Turn regulatory hurdles in medical devices into your market edge at NEPCON Thailand 2026. Discover precision 3D Laser Profilers and AOI systems designed for zero-defect assembly. Ensure seamless QMSR compliance with Smart Factory solutions featuring real-time data logging and UDI traceability. Connect with specialized Medical-grade EMS providers to refine your Design for Manufacturability (DFM) early. This will improve production quality, reduce compliance risk, and accelerate time to market, ensuring sustainable business and global competitiveness achievement. |
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