Regulatory Compliance in Global Device Markets

Abstract

Medical device manufacturers seeking global market access must navigate a fragmented regulatory landscape spanning the FDA's premarket review system, the European Union's MDR 2017/745, Japan's PMDA approval pathway, China's NMPA registration process, and the IMDRF harmonisation framework -- each imposing distinct requirements for clinical evidence, quality system documentation, and post-market surveillance that collectively multiply compliance costs by 3-5 fold compared to single-market registration. This study presents the Global Device Regulatory Compliance Assessment Framework (GDRCAF), evaluating five compliance strategies -- sequential single-market submissions, parallel multi-market filing, MDSAP-leveraged harmonised auditing, regulatory intelligence platform-assisted compliance, and AI-driven regulatory pathway optimisation -- across four compliance tasks: submission documentation efficiency, clinical evidence reuse, quality system audit harmonisation, and post-market surveillance alignment. Our Global Regulatory Compliance Score (GRCS) integrates documentation efficiency, evidence leverage ratio, audit burden reduction, surveillance harmonisation, and time-to-market across jurisdictions. AI-driven regulatory pathway optimisation achieved the highest GRCS (0.922) through NLP models that map regulatory requirement differences across 12 jurisdictions and generate gap analyses that reduced redundant documentation by 46%, while MDSAP-leveraged auditing achieved the highest audit burden reduction (0.955) through single-audit recognition across five participating regulatory authorities.