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Artwork for Accès au Marché Mondial des Dispositifs Médicaux

Accès au Marché Mondial des Dispositifs Médicaux

Pure Global

Maîtrisez chaque marché. Accélérez chaque lancement. "Accès au Marché Mondial des Dispositifs Médicaux" est le podcast qui transforme les parcours réglementaires les plus complexes du monde en feuilles de route claires et actionnables. Si vous êtes un fondateur de MedTech, un responsable des affaires réglementaires/qualité, un chef de produit ou un investisseur qui doit obtenir l'approbation de di... more

PublishesDailyEpisodes243Foundeda year ago
Language
French
Number of ListenersCategories
Life SciencesTechnologyScience

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Artwork for Accès au Marché Mondial des Dispositifs Médicaux

Latest Episodes

À compter du 1er juillet 2026, la Therapeutic Goods Administration (TGA) d'Australie rend obligatoire l'Identification Unique des Dispositifs (IUD) pour les dispositifs médicaux à haut risque (Classe IIb et Classe III). Cet épisode détaille les oblig... more

Le 29 juin 2026, la Commission européenne a élargi la liste des 'technologies bien établies' (WET) sous le RDM de l'UE. Cette mise à jour exempte des dizaines de nouveaux types de dispositifs, y compris certains cathéters, implants dentaires et systè... more

Cet épisode analyse les 'Principes Directeurs pour la Classification des Dispositifs Médicaux d'Interface Cerveau-Machine (BCI)' (Annonce n° 24) publiés par la NMPA en Chine le 30 juin 2026. Nous explorons comment ce premier cadre réglementaire défin... more

Cet épisode explore l'annonce par la FDA de la réunion publique du 22 juillet 2026 concernant la réautorisation des Amendements sur les frais d'utilisation des dispositifs médicaux (MDUFA VI) pour les années fiscales 2028-2032. Nous expliquons le cad... more

Le 1er juillet 2026, l'ANVISA du Brésil a lancé son nouveau système de déclaration d'événements indésirables, e-Notivisa, remplaçant la plateforme existante. Cet épisode explore les caractéristiques clés du nouveau système, y compris son alignement o... more

Cet épisode explore la nouvelle Instruction Normative 290/2024 de l'ANVISA au Brésil, effective en juin 2026. Nous analysons comment cette réglementation introduit un processus de modification plus flexible pour la voie de dépendance réglementaire de... more

Cet épisode analyse le guide MDCG 2026-4 de l'UE, qui transfère la responsabilité du téléchargement du Résumé des Caractéristiques de Sécurité et des Performances Cliniques (SSCP) dans EUDAMED, des Organismes Notifiés aux fabricants. Nous couvrons le... more

La Chine accélère considérablement l'approbation des dispositifs médicaux innovants, avec 40 nouvelles approbations par la NMPA au premier semestre 2026, portant le total à 431. Cet épisode analyse cette tendance, expliquant comment les délais d'exam... more

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Apple Podcasts
#236
France/Science/Life Sciences
Apple Podcasts
#4
Spain/Science/Life Sciences
Apple Podcasts
#73
Spain/Science
Apple Podcasts
#227
Belgium/Science/Life Sciences

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this podcast launched a year ago and published 243 episodes to date. You can find more information about this podcast including rankings, audience demographics and engagement in our podcast database.

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