Health Canada Updates Guidance for Private Label Medical Device Licence Applications
Health Canada has updated its guidance for Class II, III, and IV private label medical device licence applications. Learn what manufacturers need to know about REP submissions, MDSAP requirements, documentation expectations, and compliance implications.
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.
European Commission Expands MDR List of Devices Exempt from Clinical Investigations
The European Commission expands the list of implantable and Class III devices exempt from clinical investigations under MDR Article 61. Key regulatory update for manufacturers.