Canada: New fees came into force on 1 April 2020 USA: Ban on electrical stimulation devices used for self-injurious or aggressive...

USA: FDA medical device user fees for fiscal year 2020 increase by almost 6% USA: Comments sought on possible exemption of powered...

Canada: New fees and performance standards for medical devices effective 1 April 2020 Canada: New medical device incident reporting...

Canada: Medical device fees increased by 2% from 1 April 2019 Canada: ‘Medical Devices Regulations’ updated to refer to 2016 edition of...

Canada: Non-compliant device labels may now be relabelled/corrected after importation Canada: Priority review process for device...

Apple worked closely with the Biologics Consulting Group to attain approval for the De Novo request for their new ECG app on the Apple...

Canada: Changes to evidence requirements for Class II and Class III infusion pumps Canada: Applications for medical device...

Canada: Further reductions to MDSAP audit durations have been announced for small companies Canada: Health Canada is adopting the Global...

Canada: Medical device fees increased by 2% from 1 April 2018 Canada: New Digital Health Review Division to be established Canada:...

Canada: Introduction of reduced MDSAP audit times Canada: Regulations affecting dental x-ray equipment have been amended Canada: Proposed...

Canada: Comments solicited on proposed new fees for medical devices and pharmaceuticals USA: Key provisions of the ‘FDA Reauthorization...

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...

Canada: Medical device fees increased by 2% from 1 April 2017 Canada: Static magnets may not be promoted with medical claims Canada:...

Canada: Non-eCTD electronic-only format to be used for medical device regulatory activities Canada: Scientific and clinical content of...