USA – FDA recognizes three new international medical device software security standards
The US Food and Drug Administration (FDA) has recognized three new standards related to software security on medical devices. The standards address taking a...
Australia – Update: TGA defines which digital mental health software it regulates
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...
Europe – MDCG 2022-12 – Harmonised administrative practices and alternative technical solutions until Eudamed...
Article 33 of Regulation (EU) 2017/745 on medical devices (MDR) and Article 30 of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)...
France – Arrêté du 22 février 2023 portant approbation du référentiel d’interopérabilité et de...
Le ministre de la santé et de la prévention,
Vu le règlement (UE) 2016/679 du Parlement européen et du Conseil du 27 avril 2016 relatif...
USA – FDA official discusses use cases, limits for device PCCPs
While predetermined change control plans (PCCPs) may not typically be appropriate for changes to a device’s indications for use, they can be useful for...
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...
South Korea – MFDS rules on medical device insurance and designated non-clinical testing institutions
South Korea’s Ministry of Food and Drug Safety (MFDS) has announced updates to several medical device and in vitro diagnostic (IVD) regulations.
The announcements include:
...
New Zealand – Guideline on the Regulation of Therapeutic Products in New Zealand
Pharmacovigilance is defined by the WHO as the science and activities relating to the
detection, assessment, understanding and prevention of adverse events or any medicinerelated...
USA – Studies linking recalled 510(k) devices to problematic predicate products are ‘warning shot’...
Two recent studies that link the recall of 510(k)-cleared medical devices to problematic predicate products should serve as a “shot across the bow” for...
USA – FDA revises final guidance on modifying remote monitoring devices
The US Food and Drug Administration (FDA) has updated final guidance on its enforcement policy for remote patient monitoring devices in an effort to...
