International – FDA, Health Canada, MHRA release guiding principles on transparency for machine learning...
The US Food and Drug Administration (FDA), Health Canada, and the UK Medicines and Healthcare products Regulatory Agency (MHRA) have released additional guiding principles...
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 – 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 – Requirements for Regulatory Authority Recognition of Conformity Assessment Bodies Conducting Medical Device...
Standards perform a key role in the conformity assessment process; however, utilizing
existing standards for recognition of medical device CABs performing regulatory
reviews presents challenges. Regulatory...
International – Essential Principles of Safety and Performance of Medical Devices and IVD Medical...
This document applies to all medical devices and IVD medical devices and is intended
to identify and describe essential principles of safety and performance which...
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 – 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...
