Podcast Episodes
Back to Search
SFDA Medical Device Advertising: Responding to Enforcement in Saudi Arabia
On September 6, 2026, the Saudi Food and Drug Authority (SFDA) announced legal action against a medical device company for misleading advertising. Th…
1 month ago
Australia TGA Device Classification Rules: Saline Flush Syringes Reclassified to Class IIa
Australia's Therapeutic Goods Administration (TGA) has introduced a new classification rule, Clause 2.2, that reclassifies non-invasive devices conta…
1 month ago
China NMPA Approves LEQEMBI Autoinjector: A Signal for Drug-Device Combination Products
This episode examines the September 3, 2026, approval of the LEQEMBI (lecanemab) subcutaneous autoinjector by China's NMPA. We explore how this shift…
1 month ago
Brazil ANVISA High-Risk Device Registration: Public Consultation No. 1,248 Explained
This episode details Brazil ANVISA's Public Consultation No. 1,248, published on August 26, 2026, which proposes a new regulatory framework for the r…
1 month ago
Brazil ANVISA's New Notification Guidance: What Class I/II Medical Device and IVD Manufacturers Need to Know
Brazil's ANVISA has published two new guidance manuals detailing the 'notification' pathway for Class I and II medical devices and IVDs. This episode…
1 month ago
Singapore HSA's New Registration Pathway for Special Access Route (SAR) Devices
Singapore's Health Sciences Authority (HSA) launched a Registration Support Initiative on August 28, 2026, to help transition clinically important me…
1 month ago
UK MHRA Health Bill Amendments 2026: New Powers for Future Device Regulation
The UK government has proposed three amendments to the Health Bill, introduced on September 1, 2026, that grant significant new powers to the MHRA. T…
1 month ago
UK MHRA's New Licensing Powers: What the 2026 Health Bill Amendments Mean for Medical Device Manufacturers
This episode explores the significant amendments to the UK Health Bill introduced on September 1, 2026, which grant the MHRA new powers to establish …
1 month, 1 week ago
UK MHRA Non-Compliant Devices: DSI/2026/007 and Supply Chain Risks
The UK's MHRA has issued Device Safety Information notice DSI/2026/007, warning of non-compliant medical devices on the UK market lacking valid UKCA …
1 month, 1 week ago
Australia TGA Consultation on Medical Device Information Sharing: What Sponsors Need to Know
Australia's Therapeutic Goods Administration (TGA) has launched a consultation on proposals to increase the public sharing of medical device informat…
1 month, 1 week ago