medical devices

Hong Kong

Hong Kong Regulatory Processes Overview

Regulatory System Medical Device regulations and import in Hong Kong operates under its own framework, controlled by the Medical Device Control Office (MDCO), a division of the Department of Health...

Harmonization in Plain Sight. Are FDA and CE Substantially Equivalent?

Medical device harmonization continues to struggle, with substantial differences between FDA and Europe continuing to be an obstacle. However, current changes in Europe and proposed changes in the US may...

TGA Introduces Patient Implant Cards…and the dates are approaching fast!

In October 2017, the Australian government approved regulations introducing requirements for manufacturers to provide consumer information with all new permanently implantable devices (other than those exempted) supplied in Australia. As...
Checklist 2

Adverse Events Increase in Australia

During August, the Therapeutic Goods Administration (TGA) published their 2017 overview of post-market monitoring in Australia. The report shows a sharp increase in the reporting of Adverse Events from 2017,...
Global expanding

Taking a 510(k) Down Under…leveraging US (and Canadian and Japanese) approvals for TGA registration

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