Le Cœur CARMAT (CARMT TAH) éligible au forfait innovation (HAS) sous conditions de nouvelles données cliniques

France – Le Cœur CARMAT (CARMT TAH) éligible au forfait innovation (HAS) sous conditions...

Si les études cliniques disponibles, à la date de la demande, établissent que l’utilisation de CARMAT TAH est susceptible d’apporter un bénéfice clinique important...
India Commits to Phased Overhaul of Medical Device Regulations

India – India Commits to Phased Overhaul of Medical Device Regulations

The Indian government has set out the timeline for moving to a new regulatory system for medical devices. Officials intend to institute a law...
Seegene's COVID-19 test authorized for emergency use in Korea

South Korea – Seegene’s COVID-19 test authorized for emergency use in Korea

Korea Centers for Disease Control & Prevention notified Seegene Inc. (096530.KQ) that Korea Ministry of Food and Drug Safety (MFDS; Former KFDA) approved its...
FDA teams with India to stop counterfeit shipments

USA – FDA teams with India to stop counterfeit shipments

The U.S. Food and Drug Administration today announced that its first bilateral enforcement operation with the Government of India, stopped approximately 500 shipments of illicit,...
Review of Medicines and Medical Devices Regulation (MMDR).

Australia – Review of Medicines and Medical Devices Regulation (MMDR)

Australia's regulatory framework for therapeutic goods is undergoing a number of changes in response to the Review of Medicines and Medical Devices Regulation (MMDR). The Government accepted...
Modernizing ClinicalTrials.gov: NIH Seeks Feedbackowser for precision medicine research

USA – Modernizing ClinicalTrials.gov: NIH Seeks Feedback

As part of a multi-year modernization initiative, the National Institutes of Health’s (NH) National Library of Medicine (NLM) is seeking comments from users and...
Update: Expanded scope of medical device regulations, plus new expedited registration route

India – Update: Expanded scope of medical device regulations, plus new expedited registration route

India’s Central Drugs Standard Control Organization (CDSCO) has expanded the scope of products falling under medical device regulation in the country, and also established...
Remboursement de DM : un webinaire de la HAS pour réduire les non-conformités

France – Remboursement de DM : un webinaire de la HAS pour réduire les...

Le 27 février prochain, la HAS organise un webinaire pour expliquer comment préparer et déposer son dossier d'évaluation sur la plate-forme dématérialisée sésame, mise...
ISO 14971 :2019 - GAP-ANALYSIS résumé versus l’ancienne version ISO EN FR 14971 : 2013.

International – ISO 14971 : 2019 – GAP-ANALYSIS résumé versus l’ancienne version ISO EN...

  Cliquez ici pour accéder au résumé Nous contacter pour la version complète.  
Double peine pour la medtech suisse

Switzerland – Double peine pour la medtech suisse

En 2010, le scandale des implants mammaires frauduleux fabriqués en France a mis en exergue les lacunes du système européen de certification des dispositifs...

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