Australian medical device regulators preparing Brexit contingency plans

Australia – Australian medical device regulators preparing Brexit contingency plans

The Australian TGA has drawn up plans to blunt the impact of Brexit on the country’s medical device market. TGA will continue recognizing...
Levothyrox : l’ANSM publie les dernières données issues de l’enquête de pharmacovigilance

France – ANSM : L’ANSM lance une consultation publique sur un projet de recommandations...

C’est la première fois en Europe que des recommandations dans ce domaine sont élaborées et l’ANSM a partagé ses travaux avec la Commission européenne...
Determining Whether to Submit an ANDA or a 505(b)(2) Application - Guidance for Industry

USA – Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19)...

The Food and Drug Administration (FDA or the Agency) plays a critical role in protecting the United States from threats such as emerging infectious...
LNE-GMED

France – Le LNE filialise son activité GMed de certification médicale

Depuis cinq ans, la certification des dispositifs médicaux connaît un véritable bouleversement. La croissance des exigences normatives et règlementaires a généré une croissance importante...
Access our Canada medical device regulatory chart in RAMS

Canada – Health Canada Developing MDL Policies for 3D-Printed Medical Devices

EMERGO SUMMARY OF KEY POINTS: Health Canada to publish new guidance on MDL requirements for 3D-printed medical devices. The Draft guidance will cover Class...
New Virtual Surgical Simulator Debuts in Germany

Germany – New Virtual Surgical Simulator Debuts in Germany

Researchers presented the latest innovation in surgical training at this year’s MEDICA 2018 conference in Düsseldorf, Germany — the HandsOn.surgery trainer. The new prototype...
Déployer des dispositifs médicaux IoT en toute confiance

Europe – Déployer des dispositifs médicaux IoT en toute confiance

Alors que l’année 2020 approche, le nombre d’appareils connectés progresse en capacité, augmente en nombre et révolutionne toutes les formes de communication. Ces dispositifs...
FDA finalizes guidance on clinical, in vitro drug interaction studies

USA – FDA Warns Against Using Implanted Pumps With Unapproved Drugs

The US Food and Drug Administration (FDA) on Wednesday warned physicians against using implantable pumps to deliver pain medications directly into patients’ spinal fluid...
Wearable device studied for detection of pediatric anxiety, depression

USA – Wearable device studied for detection of pediatric anxiety, depression

When Ellen McGinnis started her career as a psychologist several years ago, she realized just how hard it can be to spot anxiety and...
TEAM-NB : Survey on NBs applications against IVD new regulation

Europe – TEAM-NB : Survey on NBs applications against IVD new regulation

Following interest from the sector concerning the designation process in the framework of the IVDR regulation and as an act of transparency, you will find...

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