EU/US: Cooperation on development of UDI database specifications
IMDRF: Assembly and technical guide for IMDRF ToC submissions
IMDRF: Clinical evaluation documents updated and circulated for comment
ISO: Updated standards on packaging for terminally sterilised medical devices
WHO: Draft policy on remaining shelf-life of medical products
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The WCO reminds the general public to exercise extreme caution when purchasing critical medical supplies from unknown sources, particularly online. The use of these goods may cost lives. While the wor
The World Health Organization (WHO) supports the implementation of reliance on other regulators’ work as a general principle, making optimal use of available resources and expertise. When built upon G
AHWP: Proposed competency framework for medical technology regulators IMDRF: Principles and practice for medical device cybersecurity are drafted IMDRF: Requirements for Regulatory Authority recogniti
