International – Final Document- Principles of Labelling for Medical Devices and IVD Medical Devices
The purpose of this IMDRF guidance is to provide globally harmonized labeling
principles for medical devices, including in vitro diagnostic (IVD) medical devices, and
support IMDRF/GRRP...
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 – 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...
International – Predetermined Change Control Plans for Machine Learning-Enabled Medical Devices: Guiding Principles
In 2021, the U.S. Food and Drug Administration (FDA), Health Canada, and the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) jointly identified 10...
International – IMDRF guidance updates thinking on personalized medical devices
The International Medical Device Regulators Forum (IMDRF) says personalized medical devices (PMD) come in three varieties that require different regulatory approaches. As certain technologies...
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,...
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 – IMDRF guidances address cybersecurity, personalized devices and surveillance
The International Medical Device Regulators Forum (IMDRF) released four final guidances this week that address cybersecurity best practices, verification and validation for personalized medical...
International – IMDRF guidance aims to harmonize, streamline review reports
The International Medical Device Regulators Forum (IMDRF) recently published guidance intended to streamline regulatory reporting requirements across jurisdictions. The document lays out expectations not...
International – IMDRF publishes updated guides covering governance activities and membership
The International Medical Device Regulators Forum (IMDRF) recently posted a series of updated guidelines on the group’s standard operating procedures (SOP), criteria for joining,...
