IVD

Reform

Regulatory Change in Australia – TGA’s wish list for 2019

TGA works hard to keep up to date in this rapidly changing world and that’s certainly the case this coming year. An indication of reforms to come can be gained...
Brexit

Brexit – BSi confirms UK issued CE to become invalid

Brexit - this is where the wheels come off: UK (and now Dutch) Notified Body BSi has advised that all UK issued CE certificates become invalid in case of no...
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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...
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FDA gives thumbs up to digital submissions

In a proposed rule announced 13 September, US FDA plans to do away with paper submissions. The agency isn’t quite going fully digital yet – you still have to mail...

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