Saudi Arabia ? FDA updates guideline on device marketing authorisation procedures

摘要

The Saudi Food and Drug Authority has updated its guidance on medical device marketing authorisation procedures to clarify, among other things, the requirements for cases where more than one device type is grouped or bundled in a single application procedure.The revised guideline states that the grouped devices should all have been authorised for marketing in any of the five founding member regions of the Global Harmonization Task Force (ie the US, the EU, Japan, Australia and Canada).The Saudi medical device marketing authorisation application should be based on the authorisations granted in the GHTF regions, it states.