Health Canada publishes new guidance on “significant change” for medical devices
Health Canada clarifies when medical device changes require licence amendments. Key insights for manufacturers on risk, software, and design changes.
MHRA Issues Updated Guidance on Submitting Clinical Investigation Proposals
MHRA releases new 2026 guidance on clinical investigation submissions via IRAS. Key requirements, timelines, and implications for manufacturers.
TGA Updates PRAC Guidance: What Sponsors and Manufacturers Need to Know in 2026
The TGA updated its PRAC recall procedure in February 2026. Here’s what medical device and medicine manufacturers must know about compliance and market actions in Australia.