• Kothwala Dr. Deveshkumar
• Patel Sheetal
• Singhariya Sunil

This review provides a comprehensive examination of medical device regulatory requirements across Rest-of-World (RoW) markets those beyond the U.S. FDA, EU EMA, and Japan PMDA regimes. With RoW economies such as India, China, Brazil, and South Korea expanding rapidly, manufacturers face increasingly heterogeneous regulatory environments. This review critically analyzes country-specific frameworks, classification systems, documentation standards, and approval pathways, while synthesizing commonalities and deviations. We also assess trends in reliance models, harmonization efforts (ASEAN, African Medicines Agency), and digital transformation initiatives such as e-submissions and unique device identification (UDI). Unlike descriptive regulatory summaries, this review offers comparative insights into approval timelines, risk-based classifications, and strategic navigation. Case studies highlight challenges in Brazil’s GMP inspections, China’s in-country testing, and India’s MDR 2017 reforms. Future perspectives explore digital health integration, AI-enabled reviews, and the potential of real-world evidence (RWE) to transform compliance. By situating regulatory acumen as a strategic enabler, this review equips regulatory professionals, compliance officers, and global strategists with actionable intelligence for accelerated, sustainable market access.

Rest-of-World (RoW) markets, medical device regulation, regulatory harmonization, digital health, market access strategies.

"“Medical Device Regulation in Rest-of-World (RoW) Markets: Comparative Frameworks, Harmonization Trends, and Strategic Insights”", International Journal of Emerging Technologies and Innovative Research (www.jetir.org), ISSN:2349-5162, Vol.12, Issue 11, page no.d101-d108, November-2025, Available :http://www.jetir.org/papers/JETIR2511313.pdf

"“Medical Device Regulation in Rest-of-World (RoW) Markets: Comparative Frameworks, Harmonization Trends, and Strategic Insights”", International Journal of Emerging Technologies and Innovative Research (www.jetir.org | UGC and issn Approved), ISSN:2349-5162, Vol.12, Issue 11, page no. ppd101-d108, November-2025, Available at : http://www.jetir.org/papers/JETIR2511313.pdf