Swissmedic Updates Information Sheet on Procurement of Medical Devices in Healthcare Institutions
Swissmedic has updated its information sheet on procurement of medical devices in healthcare institutions, covering conformity evidence, swissdamed registration, CH-REP and importer information, UDI, implant cards and non-conforming devices.
FDA Updates Recognized Biocompatibility Standards – Recognition List No. 065
FDA Recognition List 065 updates biocompatibility standards, including ISO 10993-4 Amendment 1 and multiple ASTM revisions. Impact for manufacturers.
Health Canada publishes new guidelines on the use of technical standards to demonstrate compliance with the Medical Devices Regulations
In January 2025, Health Canada published a new guide on the use of recognized standards to demonstrate compliance with the requirements of the Medical Devices Regulations. The document guides manufacturers in preparing submissions, updates and lifecycle management of applicable standards.