IMDRF Seeks Input on Regulatory Pathways for Personalized Medical Devices

International – L’IMDRF publie un document concernant la classification des DMDIV

The objective of the International Medical Device Regulators Forum (IMDRF) is to encourage convergence at the global level in the evolution of regulatory systems...

International – Facebook développe une montre connectée tournée vers la santé

Malgré son échec face à Google lors de la vente de Fitbit en 2019, Facebook est bien décidé à entrer sur le marché des...
Saudi FDA extends GHAD deadlines, issues guidance documents

Saudi Arabia – Saudi classification guidance explicates submissions process and product changes

The Saudi Food and Drug Administration (SFDA) has published version 4.1 of the Saudi FDA Products Classification Guidance. New in this version is a section...

International – January’s Regulatory Focus: The impact of disruption on the global regulatory community

Feature articles during January focused the effects of disruption on global regulatory practice. In context of the COVID-19 pandemic, authors examined expedited approval pathways...
WHO drafts guidance for pharma supply chain tracking

International – WHO’s Essential Diagnostics List updated for COVID-19

The World Health Organization (WHO) updated its list of essential diagnostics for 2021 on Friday to include recommendations for polymerase chain reaction and antigen-based...

Egypt – Egypt will begin requiring registration of IVD reagents

The Egyptian Drug Authority (EDA) has announced (link in Arabic) that it will begin requiring registration for IVD reagents. Implementation of this new requirement will proceed...
ISO 14971 :2019 - GAP-ANALYSIS résumé versus l’ancienne version ISO EN FR 14971 : 2013.

International – La norme ISO 10993-21 est publiée

This document specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation. The...

International – Intellectual Property at the Intersection of Medical Devices and Artificial Intelligence

A medical device generally can be described as any device intended to be used for medical purposes, such as to benefit patients by (a) helping healthcare providers diagnose and...
Évaluation biologique des dispositifs médicaux — Partie 23 : Essais d'irritation PR NF EN ISO 10993-23 - Enquête Publique - Date de clôture : 05/07/2019

International – Design with the end in mind

Applying human factors engineering (HFE) best practices has enabled medical device manufacturers to delve into the realm of design thinking and provided users with...

International – Cold chain management for COVID-19 vaccines: Ensuring safe and effective distribution

As governments, industry and other entities begin COVID-19 vaccine distribution efforts worldwide, cold chain management has emerged as a crucial factor for ensuring vaccine...

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