North America - May 2020
Canada: New fees came into force on 1 April 2020 USA: Ban on electrical stimulation devices used for self-injurious or aggressive...
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ARQon
Dec 4, 20191 min read
North America - Nov/Dec 2019
USA: FDA medical device user fees for fiscal year 2020 increase by almost 6% USA: Comments sought on possible exemption of powered...
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ARQon
Aug 30, 20191 min read
North America - Aug 2019
Canada: New fees and performance standards for medical devices effective 1 April 2020 Canada: New medical device incident reporting...
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ARQon
Jun 28, 20192 min read
North America - Jun 2019
Canada: Medical device fees increased by 2% from 1 April 2019 Canada: ‘Medical Devices Regulations’ updated to refer to 2016 edition of...
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ARQon
Mar 29, 20192 min read
North America - Mar 2019
Canada: Non-compliant device labels may now be relabelled/corrected after importation Canada: Priority review process for device...
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ARQon
Nov 19, 20181 min read
Apple obtains last minute De Novo application approval: Just in time for the Apple Watch 4 reveal
Apple worked closely with the Biologics Consulting Group to attain approval for the De Novo request for their new ECG app on the Apple...
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ARQon
Nov 5, 20182 min read
North America - Dec 2018
Canada: Changes to evidence requirements for Class II and Class III infusion pumps Canada: Applications for medical device...
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ARQon
Sep 4, 20182 min read
North America - Aug/Sep 2018
Canada: Further reductions to MDSAP audit durations have been announced for small companies Canada: Health Canada is adopting the Global...
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ARQon
May 23, 20182 min read
North America - May 2018
Canada: Medical device fees increased by 2% from 1 April 2018 Canada: New Digital Health Review Division to be established Canada:...
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ARQon
Feb 2, 20184 min read
North America - February 2018
Canada: Introduction of reduced MDSAP audit times Canada: Regulations affecting dental x-ray equipment have been amended Canada: Proposed...
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ARQon
Jan 1, 20182 min read
North America - December 2017
Canada: Comments solicited on proposed new fees for medical devices and pharmaceuticals USA: Key provisions of the ‘FDA Reauthorization...
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ARQon
Sep 1, 20172 min read
Drugs - August 2017
US: FDA and Beyond – REMS 1.16 Subheading Instructions for eCTD M1 v2.3 (DTD 3.3) US: Manual of Policies and Procedures(MAPP) 6021.1...
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ARQon
Aug 24, 20171 min read
North America - May 2017
Canada: Medical device fees increased by 2% from 1 April 2017 Canada: Static magnets may not be promoted with medical claims Canada:...
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ARQon
Apr 4, 20172 min read
North America - April 2017
Canada: Non-eCTD electronic-only format to be used for medical device regulatory activities Canada: Scientific and clinical content of...
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