Saudi FDA extends GHAD deadlines, issues guidance documents

Saudi Arabia – Saudi FDA extends GHAD deadlines, issues guidance documents

With the Saudi Food and Drug Administration (SFDA) in the process of implementing a new regulatory system, medical device manufacturers active in Saudi Arabia will...
DM et Phtalates

International – DM et Phtalates

Guidelines on the benefit-risk assessment of the presence of phthalates in certain medical devices covering phthalates which are carcinogenic, mutagenic, toxic to reproduction (CMR)...
US FDA recognizes latest edition of ISO 14971 as medical device consensus standard

International – Improving Biosecurity with first International Standard for Biorisk Management

SARS, pandemic viruses and threats of the malicious use of pathogens have all woken the world up to the risks of biological materials and...
Unique Device Identification and Recall Management: Starting with the Patient in Mind

International – Unique Device Identification and Recall Management: Starting with the Patient in Mind

This article provides an overview of FDA’s medical device Unique Device Identification System Final Rule and explains why including UDIs in health information and in...
WHO Drafts Policy on Designating Regulators as Listed Authorities

International – WHO Drafts Policy on Designating Regulators as Listed Authorities

With an eye toward strengthening the regulation of medical products in underserved regions, the World Health Organization (WHO) late last year published a draft...
2019 in Review: All Eyes on MDR/IVDR, PRV Records and What’s Coming in 2020

International – 2019 in Review: All Eyes on MDR/IVDR, PRV Records and What’s Coming...

As 2019 comes to a close, Focus takes a look back at what articles received the most attention as well as what to expect for the...
US FDA recognizes latest edition of ISO 14971 as medical device consensus standard

International – Nouvelle version 2019 de la norme ISO 14971:2019

Le présent document spécifie la terminologie, les principes et un processus de gestion des risques relatifs aux dispositifs médicaux, y compris les logiciels utilisés en tant que dispositifs médicaux et les dispositifs...
Saudi FDA moves to single electronic platform for medical device registrations

Saudi Arabia – Saudi FDA moves to single electronic platform for medical device registrations

Saudi Arabia’s Saudi Food and Drug Authority (SFDA) have rolled out a single registration platform for all medical device market authorization, authorized representation and...
Report: Medtech-related adverse events more in women than in men

International – Report: Medtech-related adverse events more in women than in men

A new investigation of FDA adverse event data has revealed that more women are harmed by medical devices than men. The report published by the International Consortium...
The Transformation of Digital Health: What it Means for Regulatory Professionals

International – The Transformation of Digital Health: What it Means for Regulatory Professionals

Articles throughout November focused on what the changing digital health landscape, including big data, means for regulatory professionals. Leaders in the digital health space...

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