- Jul 30, 2020
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...
- Dec 4, 2019
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...
- Aug 30, 2019
North America - Aug 2019
Canada: New fees and performance standards for medical devices effective 1 April 2020 Canada: New medical device incident reporting...
- Jun 28, 2019
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...
- Mar 29, 2019
North America - Mar 2019
Canada: Non-compliant device labels may now be relabelled/corrected after importation Canada: Priority review process for device...
- Nov 19, 2018
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...
- Nov 5, 2018
North America - Dec 2018
Canada: Changes to evidence requirements for Class II and Class III infusion pumps Canada: Applications for medical device...
- Sep 4, 2018
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...
- May 23, 2018
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:...
- Feb 2, 2018
North America - February 2018
Canada: Introduction of reduced MDSAP audit times Canada: Regulations affecting dental x-ray equipment have been amended Canada: Proposed...