Europe – Outil de filtrage pour le règlement européen sur les DMDIV

Si la date limite du règlement européen sur les dispositifs médicaux (UE) 2017/745 (RDM) avait été reportée d'un an, à mai 2021, le calendrier...

Australia – Software for use with COVID-19 rapid antigen self-tests

This guidance includes information about the Therapeutic Goods Administration's (TGA) requirements for software and apps designed for use with COVID-19 rapid antigen self-tests...

International – Robotic Surgery Ecosystem: The path to democratize surgery

Robotic surgery has been one of the fastest growing healthcare sectors in recent years. With the aim to ensure that surgeries become more precise,...
As coronavirus roils region, EU device body adamant about steps to hit MDR deadline

Europe – Deal on stronger role for EU medicines regulator

The European Medicines Agency’s (EMA) capacity to manage the availability of medicinal products and medical devices will be strengthened with the creation of two...
CORONAVIRUS : India halts exports of about 2 dozen APIs, drugs

India – Indian regulators propose easing ISO 13485-related requirements for medical device registrants

India’s Ministry of Health and Family Welfare has proposed easing medical device registration requirements related to proof of ISO 13485 quality management system (QMS)...

USA – FDA Provides New Draft Guidance on Premarket Submissions for Device Software Functions

“As technology continues to advance all facets of health care, software has become an important part of many products and is integrated widely into...

International – FDA Collaborates with Health Canada and UK’s MHRA to Foster Good Machine...

“With artificial intelligence and machine learning progressing so rapidly, our three regulatory agencies, together, see a global opportunity to help foster good machine learning...

USA – FDA Strengthens Safety Requirements and Updates Study Results for Breast Implants

Today, the U.S. Food and Drug Administration took several new actions to strengthen breast implant risk communication and help those who are considering breast...

USA – CDRH outlines guidance plans for FY2022

The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) on Tuesday released its list of guidances it intends to...
Saudi FDA extends GHAD deadlines, issues guidance documents

Saudi Arabia – Saudi FDA extends deadlines for Unique Device Identification compliance

The Saudi Food and Drug Authority (SFDA), Saudi Arabia’s medical device market regulator, has revised compliance timeframes regarding the country’s Unique Device Identification (UDI)...

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