Category: Medical Devices

ARIM, Brexit, eCTD, EMA, Medical Devices, RIM Smart

Brexit and Health Products — Down to the Wire

As of this writing, The United Kingdom is expected to complete the Article 50 separation from the European Union — nicknamed Brexit — on March 29, just four weeks away. At this point, there is little expectation that the UK will remain in the trade union, or continue to use the regulations of the European …

eCTD, eCTD 4, FDA, IDMP, Medical Devices

2019 FDA Goals: A Christmas Wish List

Image Credit Angie Chapman https://www.flickr.com/photos/angiet-cakefiend/7178335187/in/photolist-bWjQXM-5Nzjum-5Nvcrt-5MeAEL-2ixWd-5NvaLF-CZcM4n-7YXyHM-5eEVdZ-5eEVe6-VRZQJ5-97o4ku-FW4xX-64CNCY-X6HEUo-J3XeKS-5DgNxm-gBhhE5-X6HJ3N-7gZ4bC-5DgMhq-6khfTX-e9C6ZZ-5DcxDx-9HBaiw-nBqP7w-qBzhoK-hJYfj5-aoQA8J-iRdUdr-WTnycN-8UrP3g-7giMG1-XFeizH-8V8zy8-K6Azn-ZatFom-6z6eQG-8aNvz2-79G6Dg-XU8uhv-WntgLm-5LLfFN-SJLA7d-SKt1sH-K6kTf-QQfE51-Ujfch7-asm29b-ei5nx9

RAPS Regulatory Focus reported from the December 11, 2018 CMS/FDA Summit in Washington DC, as to Janet Woodcock’s goals for FDA in 2019. There was a focus on health, opioids, supply chain safety… all the stuff for which we all need the agency to excel, but I’m here for the changes in regulatory approval processes, …

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 …