International – ISO 15223-1:2021/Amd 1:2025 Medical devices — Symbols to be used with information...
A revised EC REP symbol, no longer tied to a specific country or region, supporting broader international use and simplifying labeling for manufacturers operating...
International – Medical Devices: Post Market Surveillance National Competent Authority Report Exchange Criteria and...
The NCAR Exchange Program will be used to exchange information relating to significant concerns or potential trends that individual authorities have observed in their...
International – IMDRF guidance details when regulators should share postmarket surveillance reports
The International Medical Devices Regulators Forum (IMDRF) has issued guidance on when and how regulators should share information about the potential risks of certain...
International – Playbook for Medical Device Regulatory Reliance Programs
This document provides high-level strategies for developing regulatory reliance programs for medical devices, along with specific considerations and steps related to actual program implementation....
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 – 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...
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 – The global regulatory landscape for AI/ML-enabled medical devices
Digital health has revolutionized the healthcare sector. Artificial intelligence (AI) and machine learning (ML) have gained widespread recognition because of their promising benefits in...
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...
