International – IMDRF finalizes good machine learning practice, software risk documents
The International Medical Device Regulators Forum (IMDRF) on Wednesday finalized two highly anticipated technical documents detailing guiding principles for good machine learning practices (GMLP)...
International – Regulatory Authority Assessment Method for Recognition and Surveillance of Conformity Assessment Bodies...
This document defines the content of the Regulatory Assessment Program and
provides guidance on the process-based assessment method. The Assessment
Program defines how Regulatory Authorities will...
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 – 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 – 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 – IMDRF publishes new procedures on membership, governance
The International Medical Device Regulators Forum (IMDRF) recently updated its procedures for membership and for developing and managing technical guidelines.
The 40-page Standard Operating Procedures...
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 – 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 – 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...
International – E-labeling and digital transformation in healthcare
This article examines the regulations for electronic labeling (e-labeling) for prescription drugs and medical devices in Japan, Brazil, Singapore, the EU and US, Canada,...
