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Brazil's New e-Notivisa System: ANVISA's Overhaul of Medical Device Adverse Event Reporting
On July 1, 2026, Brazil's ANVISA mandated the use of its new e-Notivisa system for all medical device adverse event reporting, replacing the legacy N…
3 months, 1 week ago
Brazil ANVISA Regulatory Reliance: IN 290/2024 Changes for Class III & IV Devices
Brazil's ANVISA has implemented a more flexible amendment process for its regulatory reliance pathway for high-risk medical devices under Normative I…
3 months, 1 week ago
EU MDCG 2026-4: SSCP Upload to EUDAMED for Class III & Implantable Devices
This episode covers the EU's new MDCG 2026-4 guidance, which transfers the responsibility for uploading the Summary of Safety and Clinical Performanc…
3 months, 1 week ago
China NMPA Innovative Device Approvals Accelerate: Market Access in 2026
China's NMPA is rapidly approving innovative medical devices, creating a major opportunity for global manufacturers. A new report reveals that 40 inn…
3 months, 1 week ago
Australia's TGA UDI System: Preparing for the July 1, 2026 High-Risk Device Deadline
Australia's Therapeutic Goods Administration (TGA) is launching its Unique Device Identification (UDI) system, with the first major compliance deadli…
3 months, 1 week ago
Japan PMDA SaMD Guidance 2026: AI/ML, Cybersecurity, and Classification Changes
On June 5, 2026, Japan's Pharmaceuticals and Medical Devices Agency (PMDA) issued a major update to its guidance for Software as a Medical Device (Sa…
3 months, 1 week ago
India CDSCO Proposes Faster Medical Device License Timelines
India's Central Drugs Standard Control Organisation (CDSCO) has published a draft amendment to shorten the approval timelines for medical device manu…
3 months, 2 weeks ago
South Korea Medical Device Act 2026: MFDS QMS and Distribution Changes
This episode details the critical amendments to South Korea's Medical Device Act, which took effect on July 1, 2026. The host breaks down the two mai…
3 months, 2 weeks ago
FDA AI Medical Device Draft Guidance 2026: Lifecycle Management and Submission Requirements
The FDA's June 6, 2026 draft guidance introduces significant new requirements for AI-enabled medical devices, focusing on total product lifecycle man…
3 months, 2 weeks ago
Health Canada MDEL Modernization Phase 2: 2026 Changes for Importers and Distributors
Health Canada has finalized Phase 2 of its Medical Device Establishment Licence (MDEL) modernization, with new rules taking effect on December 14, 20…
3 months, 2 weeks ago