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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
Health Canada Special Access Program: New Application Process for Medical Devices
Health Canada has modernized the application process for its Medical Devices Special Access Program (SAP) as of August 24, 2026. This episode details…
1 month, 1 week ago
UK MHRA ResMed Astral Alert: Ventilator Safety Actions for NatPSA/2026/004/MHRA
The UK's MHRA issued National Patient Safety Alert NatPSA/2026/004/MHRA on August 17, 2026, for ResMed Astral 100 and 150 ventilators manufactured be…
1 month, 1 week ago
China NMPA Medical Device Approval: Analyzing the August 12, 2026 Batch
China's NMPA announced the approval of 122 medical devices on August 12, 2026, including many from leading international manufacturers such as Medtro…
1 month, 1 week ago
Singapore HSA's New Medical Device Cybersecurity Guide (GL-10-R1): Key Principles and Actions
Singapore's Health Sciences Authority (HSA) has released its finalized 'Best Practices Guide for Medical Device Cybersecurity' (GL-10-R1), effective …
1 month, 2 weeks ago
COFEPRIS Medical Device Sanitary Registry Viewer: What Manufacturers Need to Know
Mexico's health authority, COFEPRIS, has launched the Medical Device Sanitary Registry Viewer, a public digital tool for verifying device registratio…
1 month, 2 weeks ago
India CDSCO Amends Sterilization Rules: What Removing the Loan Licence Means for Medical Devices
India's CDSCO has amended the Medical Devices Rules, 2017, effective August 24, 2024, removing the 'loan licence' requirement for manufacturers who o…
1 month, 2 weeks ago
EU Notified Body Shake-Up: What the NSAI and TÜV NORD Exits Mean for MDR Certification
The EU Notified Body landscape was shaken in August 2024 with announcements that the National Standards Authority of Ireland (NSAI) will exit its MDR…
1 month, 2 weeks ago
Japan PMDA Workshop: A Guide to Medical Device Market Entry for U.S. Firms
Japan's PMDA and AdvaMed are hosting a free online workshop on September 1, 2026, for U.S.-based small and mid-sized medtech companies. This episode …
1 month, 2 weeks ago