Month: August 2018

ARCS, ARIM, Canada, Health Canada, Medical Devices

Health Canada Updates Medical Device Submission Format

Canada XML

On August 21, Health Canada announced that they would be adopting the IMDRF “ToC” format for medical device market authorisation requests. As of April 1, 2019, Premarket Applications for Class III and IV devices (which aren’t the same classification as FDA’s Center for Devices and Radiological Health) will need to be in this format, and …

Brexit, Regulatory Update

ACUTA RIM Shots – August 16 Special Brexit Edition

Lots of Brexit-oriented news in recent days that affects the biotech industry. UK/EMA Separation Implementation Period First of all, in March, the EU and UK agreed to an ‘implementation period’ for medicines to give a little more time for the European Medicines Agency (EMA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA) to  …