From 1 December 2014, Health Canada will accept fully electronic submissions for Class III and IV device license applications, speeding up document preparation and submission, and providing for more efficient document access and workflow which should smooth the review process.
Archives for November 2014
“Today’s presentation was excellent!!! One of the best I’ve been part of all year and highly relevant to my work at Baxter.”
-Christopher L Miller, former Director Global Marketing, Baxter Healthcare
Lost at sea for some time, it has finally been confirmed that ANZTPA has sunk without trace. A joint Australia – NZ government announcement yesterday confirmed that the joint regulatory agency will not proceed.
The new Japan Pharmaceuticals and Medical Devices Law takes effect November 2014 and brings in numerous changes which streamline and harmonize devices regulations. There’s increased use of 3rd party assessors including for some Class III devices, relaxation of Japan’s unique manufacturing compliance requirements, regulation standalone software for the first time and much more.
5 November was a big day.
TGA enacted the regulatory change which provides access to Australian market via CE certification for Australian domestic manufacturers. This expedited process has been available to international manufacturers for 12 years and the anomalous treatment of the locals (who have until now been required to undergo full TGA conformity assessment, even if CE certified) has finally been corrected