FDA Publishes Medical Device User Fee Rates for Fiscal Year 2027
The U.S. Food and Drug Administration (FDA) has published the medical device user fee rates for fiscal year 2027, setting
... Read more
August 18, 2026
[searchwp_form id=1]
[blog_list]
Health Canada Opens Consultation on Proposed Changes to the List of Recognized Standards for Medical Devices
Health Canada has opened a public consultation on proposed changes to the List of Recognized Standards for medical devices. The
... Read more
August 14, 2026
MDEL Modernization Phase 2 Comes Into Force December 14, 2026
Health Canada has finalized the second phase of amendments to modernize medical device establishment licensing in Canada. The amended Medical Devices Regulations
... Read more
August 7, 2026
Health Canada Expands Its Drug and Medical Device Shortage Framework
Health Canada has strengthened its drug and medical device shortage framework. On June 17, 2026, the department published amendments to
... Read more
July 28, 2026
FDA Issues Guidance Exempting Certain Unclassified Medical Devices from 510(k) Premarket Review
The U.S. Food and Drug Administration has released guidance clarifying regulatory expectations for unclassified medical devices and 510(k) premarket notification requirements, formally
... Read more
July 3, 2026
FDA’s 2026 AI Medical Device Guidance Signals New Expectations for Manufacturers
The U.S. Food and Drug Administration has released updated guidance for AI-enabled medical devices that reshapes how manufacturers must approach the
... Read more
June 18, 2026
FDA Moves to Expand 510(k) Exemptions for Certain Class II Devices, Including Clinical Toxicology Test Systems
The U.S. Food and Drug Administration published a notice in the Federal Register on May 1, 2026, announcing its intent
... Read more
May 9, 2026
Your MDEL Renewal Is Due April 1. Here Is What to Do Before the Deadline
Missing your MDEL renewal deadline puts your entire Canadian market access at risk. Under the Medical Devices Regulations (SOR/98-282), all Medical Device
... Read more
February 18, 2026
FDA’s New AI Rules for Medical Devices: What’s Changing?
Artificial intelligence (AI) is reshaping the medical device industry, making diagnostics, treatment planning, and patient monitoring more efficient than ever.
... Read more
March 5, 2025
Health Canada Medical Device License Renewals (MDL or MDEL) in 2023
As a Canadian medical device license (MDL) holder, you are subject to an annual license renewal procedure. The renewal process
... Read more
March 22, 2023