Global Medtech Guidance Tracker: November 2021
Executive Summary
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Forty-one documents have been posted on the tracker since its last update.
You may also be interested in...
FDA’s SaMD/SiMD Guidance Could Mean Documentation Headaches For Some Software Makers, Attorney Says
A long-awaited draft guidance from the US agency delineates which medical software devices will need additional documentation based on risk – but it could also mean more work for some manufacturers.
Australia Reviews Device Classification Rules To Align With EU
Certain products would be upclassified under new Australian proposals.
EU Multistakeholder Project Aims To Give eConsent The ‘Place It Deserves’
The EU Forum for Good Clinical Practice is working on boosting the use of electronic informed consent, the uptake of which in clinical trials has been poor.