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Risk-Based Change Management for Registered Medical Devices

Risk-Based Change Management for Registered Medical Devices

APACMed’s position paper on Post-Market Surveillance and Vigilance for Medical Devices provides an analysis of current regulatory practices across APAC markets. It offers actionable recommendations for regulatory authorities to enhance safety monitoring systems while fostering innovation. Our paper aims to help industry stakeholders and regulators improve device safety and effectiveness by adopting a risk-based approach and aligning with international frameworks.

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