by arazygroup | Sep 10, 2020 | Blog
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...
by arazygroup | Aug 25, 2020 | Blog
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...
by arazygroup | Aug 21, 2020 | Blog
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...
by arazygroup | Apr 20, 2020 | Blog
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...
by arazygroup | Mar 30, 2020 | Blog
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...
by arazygroup | Feb 18, 2020 | Blog
May 2020 – MDR is less than 3 months away – Are you ready? We would like to help you with the latest updates from the EU market and make sure you are in line with the upcoming regulations. Commission News – The Delays It appears that the commission is not fully...
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