על ידי arazygroup | נוב 23, 2020 | ללא קטגוריה
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...
על ידי arazygroup | ספט 10, 2020 | ללא קטגוריה
Regulatory Update: New Guidelines of UK MHRA The UK MHRA published a new set of guidelines related to the UK medical device regulations starting from January 1st, 2021. From January 1st 2021, the Medicines and Healthcare products Regulatory Agency (MHRA) will be the...
על ידי arazygroup | אוג 25, 2020 | ללא קטגוריה
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...
על ידי arazygroup | אוג 21, 2020 | ללא קטגוריה
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...
על ידי arazygroup | אפר 20, 2020 | ללא קטגוריה
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...
על ידי arazygroup | מרץ 30, 2020 | ללא קטגוריה
Fast- Track under COVID- 19 for Health Canada & FDA Health Canada For manufacturers that want to fast-track under Covid-19, the medical device must be manufactured, sold or represented for use in relation to severe acute respiratory syndrome coronavirus 2...
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