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India medical device approval process – India medical device approval market, projected to reach $370 billion by 2025, is a dynamic and rapidly growing sector regulated by the Central Drugs Standard Control Organisation (CDSCO) under the Ministry of Health Family Welfare. The Medical Devices Rules, 2017, effective from January 1, 2018, and amended in 2020, […]

Below is a comprehensive overview of medical device regulatory affairs as it applies to medical device manufacturers. This covers key global transterritorial frameworks (US FDA, EU MDR/IVDR, and global harmonization via IMDRF), core responsibilities of manufacturers, and practical compliance strategies. 1. What is Medical Device Regulatory Affairs? Regulatory Affairs (RA) in medical devices is the

EU MDR 2026 compliance is critical for U.S. exporters of medical devices, as new import regulations, stricter CE marking rules, and updated European regulators’ oversight come into force — and ignoring them could block your products at the border. In this environment of tightening medical devices compliance and UDI/CE-marking enforcement, American manufacturers and distributors must

Breaking: EU’s 2026 Medical Device Crackdown – US Exporters Risk Billions Without These Vital Certifications Washington, D.C. pouring millions into innovative heart monitors or surgical tools, only to watch them gather dust at European ports because of overlooked paperwork. That’s the stark reality facing U.S. medical device makers as Europe’s regulatory hammer drops in 2026.