Australia – Process chart: Australia TGA regulatory approval for medical devices
Australia’s medical device market regulator has issued new guidance on digital mental health device regulation. The Therapeutic Goods Administration (TGA) published the fact sheet to inform...
India – India’s medical device regulators adopt amendment regarding cancellation and suspension of licenses
If you are a medical device manufacturer or supplier you will want to make sure to comply with the latest rules in order to...
Europe – Artificial intelligence in healthcare
In recent years, the use of artificial intelligence (AI) in medicine and healthcare has been praised for the great promise it offers, but has...
USA – FDA adds transition period to electromagnetic compatibility final guidance
The US Food and Drug Administration (FDA) has finalized guidance on medical device electromagnetic compatibility that replaces a 2016 document on the same topic....
International – Des valves cardiaques imprimées en 3D
Une équipe internationale germano-australienne a mis au point des valves cardiaques artificielles imprimées en 3D, conçues pour permettre aux propres cellules d’un patient de...
USA – Pre-submission requests for IVDs to be accepted by FDA
The FDA in January restarted accepting pre-submissions for in vitro diagnostics that would require premarket authorization or de novo clearance. Now, the agency plans...
Europe – MDR/IVDR: Commission seeks comment on revisions to standardization request
The European Commission has released a draft amendment to its Commission Implementing Decision C(2021) 2406 to update the list of harmonized standards it will...
Switzerland – Switzerland joins EU in bringing in new IVD requirements to improve patient...
The new ordinance on In vitro Diagnostic Medical Devices (IvDO) has come into force in Switzerland, bringing in stricter requirements for conformity assessment and...
Europe – New guidance from European MDCG ahead of date of application
European regulators have issued several new guidance documents relevant to medical device and in vitro diagnostic (IVD) manufacturers days before the In Vitro Diagnostic...
Europe – Europe’s MDCG clarifies IVDR requirements for using medical tests in clinical trials
Now that the IVDR 2017/746 has taken effect, new guidance for in vitro diagnostic (IVD) manufacturers with assays used in clinical trials has been published. Assays...
