Reply to Thread
Why are there no ICH guidelines for medical devices?
The focus of the ICH is on pharmaceutical products, as explained in their mission statement:
"ICH’s mission is to make recommendations towards achieving greater harmonisation in the interpretation and application of technical guidelines and requirements for pharmaceutical product registration, thereby reducing or obviating duplication of testing carried out during the research and development of new human medicines."
That said, some of the guidance documents they produce can provide useful guidance and background reading for those involved with medical devices, for example Q9 Quality Risk Management.