International – Medical Device Regulatory Review Report: Guidance Regarding Information to be Included
The scope of this guidance document is limited to the information participating IMDRF
Regulatory Authorities require in medical device regulatory review reports, the format of
reports,...
International – Diabète : un pansement intelligent pour soigner et cicatriser les plaies chroniques
Les plaies chroniques dites « non cicatrisantes » concernent des dizaines de millions de personnes dans le monde. Ainsi, de 15 % à 25 % des patients diabétiques...
International – FDA warns Philips about imaging device violations at China facility
The US Food and Drug Administration (FDA) has warned Philips about manufacturing violations at the company’s facility in Suzhou, China, where computed tomography (CT)...
International – Lancement de la plateforme MeDevIS pour améliorer l’accès aux technologies et dispositifs...
L’Organisation mondiale de la Santé (OMS) annonce le lancement en ligne du Système d’information sur les dispositifs médicaux (MeDevIS), la première plateforme mondiale d’échange...
International – IMDRF publishes AI/ML guiding principles echoing US, UK, Canadian regulators
The International Medical Device Regulators Forum (IMDRF) has published guiding principles for artificial intelligence/good machine learning (AI/ML) practices in medical device development that are...
India – Central Drugs Standard Control Organization (CDSCO) under Ministry of Health & Family...
The Ministry of Health and Family Welfare has introduced comprehensive regulations for medical devices aimed at aligning the country's regulatory framework with globally accepted...
International – IMDRF Document Implementation Report – Final document
This report (30 August 2024) provides details on the status of various medical device regulations, as self-identified by IMDRF members. It covers documents on...
International – RF Quarterly, September 2024: Artificial intelligence in medical devices
Welcome to the September issue of RF Quarterly, which includes articles examining artificial intelligence (AI) in medical devices, focusing on the global regulatory landscape, contact-free AI...
International – ISO/DIS 10993-1(en) Biological evaluation of medical devices — Part 1: Requirements and...
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried...
International – Assessment and Decision Process for the Recognition of a Conformity Assessment Body...
This document defines:
• the process and lifecycle for recognizing, maintaining, or ceasing recognition of a
CAB;
• the process of managing, grading, and closure of assessment...
