Compulsory device registration in Saudi Arabia from 2009
This article was originally published in Clinica
Saudi Arabia will launch its national medical device registration system and an adverse incident investigation system in January 2008. Registration, through the Medical Devices National Registry, will be voluntary for the first year, but from 2009, it will be compulsory for all medical devices entering the country to be approved by the Saudi Food and Drug Authority (SFDA).
You may also be interested in...
South Korea’s Qurient achieves proof of concept in a Phase II study with its first-in-class antibiotic telacebec for tuberculosis and aims to file a US NDA for the orphan drug.
VMS businesses are deemed essential in Department of Homeland Security guidance that provides as basis for orders by most states and localities across the US. During an AHPA webinar, attorney Trent Norris says the federal government prefers leaving business exemptions to shut-down decisions to the states.
Company expects clinical trials to begin by September and says first batches could be available for emergency use authorization in early 2021; J&J pledges vaccine will be available to public on not-for-profit basis.