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...
FDA finalizes contentious guidance on third party 510(k) reviews

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...
Vers une plus grande coopération des pharmacopées mondiales

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...
Double peine pour la medtech suisse

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...
MDCG 2020-3 Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD

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...
As coronavirus roils region, EU device body adamant about steps to hit MDR deadline

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...

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