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UK MHRA International Reliance: Navigating the Draft 2026 Medical Device Regulations
This episode details the UK MHRA's draft Medical Devices (Amendment) Regulations 2026, focusing on the proposed International Reliance pathway. We ex…
3 months, 2 weeks ago
Brazil ANVISA Regulatory Reliance: June 2024 Update to IN 290/2024 Streamlines Class III/IV Device Review
Brazil's ANVISA has updated its review process for the regulatory reliance pathway under IN 290/2024. As of mid-June 2024, instead of rejecting submi…
3 months, 2 weeks ago
China NMPA Post-Market Vigilance 2026: New Rules for Foreign Manufacturers
This episode provides a detailed analysis of China's NMPA new post-market vigilance framework, released on June 12, 2026. We discuss the mandatory, r…
3 months, 2 weeks ago
Saudi SFDA's 2026 AI Medical App Approval: A Global First for Vital Signs Monitoring
On June 22, 2026, the Saudi Food and Drug Authority (SFDA) issued a landmark marketing authorization for an AI-powered mobile application that measur…
3 months, 3 weeks ago
UK MHRA MDSAP Membership: Streamlining Audits for UK, US, Canada, and More
The UK's MHRA announced on June 22, 2026, its intention to become a full member of the Medical Device Single Audit Program (MDSAP). This episode expl…
3 months, 3 weeks ago
Singapore HSA COVID-19 IVD Reclassification: Class C Requirements from 2026
Singapore's Health Sciences Authority (HSA) is reclassifying all COVID-19 in-vitro diagnostic (IVD) tests from the highest-risk Class D to Class C, e…
3 months, 3 weeks ago
India CDSCO Proposes New Medical Device Import Rules for Hospitals (2026)
India's drug regulator, the CDSCO, has proposed a new framework to allow hospitals to directly import a list of 80 high-end medical devices, such as …
3 months, 3 weeks ago
Health Canada's 2026 Hyperbaric Chamber Warning: Compliance for Unlicensed Devices
Health Canada issued a public advisory on June 16, 2026, warning that unauthorized soft-shelled hyperbaric chambers are illegal to sell, import, or a…
3 months, 3 weeks ago
Health Canada MDEL Regulations 2026: What Importers and Foreign Manufacturers Need to Know
Health Canada has finalized amended regulations for its Medical Device Establishment Licence (MDEL) framework, which come into force on December 14, …
3 months, 3 weeks ago
FDA AI Software Classification 2026: Class II and PCCP Rules for Imaging Devices
On June 17, 2026, the US FDA finalized a new Class II classification for radiological machine learning-based quantitative imaging software. This epis…
3 months, 3 weeks ago