Custom Devices, Clinical Trials and the Hazards of Precedent
This past week an interesting post cropped up in the RAPS discussion board. An Australian member asked about doing clinical trials of custom-made medical devices. A surgeon inventor wanted to...
Test or Evaluate? Biocompatibility and Orthopaedic materials
This morning, the US FDA announced with a tweet, the publication of a new guidance on Ultra High Molecular Weight Polyethylene (UHMWPE) in Orthopaedic devices. "Manufacturers should include test data...
Asia-Pacific Med Dev Change Opens Up New Opportunity
Rapid regulatory change is normal in the emerging (and established) medical device markets of the Asia Pacific. Substantial changes in 2018 were no exception, including in some cases, whole new...
All Together Now – FDA Builds Devices Super Office
The biggest difference between the FDA way and the rest of the world is the separation of activities into device assessment, which comes first and involves FDA reviewers from the...
Europe’s pragmatic approach to clinical evidence for legacy devices – or why the devil is always in the detail…
Regulatory affairs demand attention to detail. So when the European Medical Devices Coordination Group released document MDCG 2019-3 - Interpretation of Article 54(2)b we regulatory geeks just knew we should...
NZ Makes it Formal – Medical Devices Reform in The Land of the Long White Cloud
New Zealand has always been a relaxed sort of place – and that included the regulation of medical devices which up till now has been limited to a simple notification...
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...
