LICENSALE Mobile Now Available!

LICENSALE Mobile Now Available!

Medtech Registration Just Became Mobile LICENSALE® Mobile is now available on the App Store and Google Play. Login with your portal registration credentials to view your registration projects from anywhere.   MARKETING STATUS View your products’ real-time...
Israeli Regulatory Pathway to the UAE

Israeli Regulatory Pathway to the UAE

UAE – Medical Device Registration for Israeli Companies The recent peace agreement brings immediate commercial opportunities for Israeli medical technology in the United Arab Emirates and through it to other members of the Gulf Cooperation Council (GCC). Arazy...
18 Days to Traditional FDA 510(k) Clearance

18 Days to Traditional FDA 510(k) Clearance

Arazy Group’s Fastest Clearance 18 Days for Traditional FDA 510(k) Clearance via the “Triage Quick” Program. On August 14, 2020 Arazy Group received its fastest Traditional 510(k) clearance via the FDA’s new expedited 30-day Triage Quick route. This is an option that...
New FDA Guidance Document Changes- COVID 19

New FDA Guidance Document Changes- COVID 19

11 COVID-19 Guidance Documents were released by the FDA, allowing the distribution and use of certain medical devices with the omission of some regulatory requirements including premarket review. See below for specific product changes. EUA Face Masks Intended for a...