Important updates for clinical, quality, and regulatory teams: A series of Field Safety Notices (FSNs) were…
Category: Regulatory Affairs
Global updates on medical device regulation and quality.
FDA Clears Innovative Essilor Stellest Eyeglass Lenses to Manage Pediatric Myopia Progression
The U.S. Food and Drug Administration (FDA) announced on September 29, 2025, the authorization of Essilor…
Olympus Recalls Specific ViziShot 2 FLEX Needles Due to Safety Concerns
Olympus Corporation has announced a voluntary global recall of certain lots of its ViziShot 2 FLEX…
FDA Approves First Pediatric Eyeglass Lenses to Mitigate Myopia Progression
The U.S. Food and Drug Administration (FDA) has authorized the marketing of Essilor Stellest eyeglass lenses.…
Swissmedic Grants Initial Authorisation for VANFLYTA®: Impact on Clinical and Regulatory Practices
Swissmedic has officially authorised VANFLYTA®, marking its initial regulatory approval. This announcement, dated September 30, 2025,…
Critical Updates: Field Safety Notices Issued for Medical Devices (15–19 September 2025)
Healthcare professionals and regulatory teams, please take note. Between 15 and 19 September 2025, a range…
GHWP Announces Voluntary Withdrawal from IMDRF Membership
On June 24, 2025, the Global Harmonization Working Party (GHWP) officially withdrew as a member of…
Health Canada Updates Terms and Conditions for Class II-IV Medical Devices
Health Canada has announced changes to the terms and conditions (T&Cs) for licences covering Class II-IV…
Health Canada Updates Food and Medical Device Regulations for Agile Licensing Framework
Health Canada has officially implemented amendments to the Food and Drug Regulations and the Medical Devices…
Health Canada Proposes Regulations to Combat Health Product Shortages in Canada
Health Canada is taking action to address health product shortages that pose risks to human health.…