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IMDRF Guidance on Supplier Controls for Medical Devices: Overview of QMS Expectations
The International Medical Device Regulators Forum (IMDRF) continues to strengthen global harmonisation of medical device quality management systems (QMS) through updated guidance focused on supplier controls and risk-based oversight. A major development in this area is the draft guidance titled “Guidance on the Control of Products and Services Obtained from Suppliers ”, published by the IMDRF Quality Management Systems Working Group. The IMDRF draft guidance provides detailed
Sharan Murugan
2 days ago2 min read
Australia (TGA) Med Dev User Guide: Completing an Application for Consent to Import, Supply, or Export a Medical Device That Does Not Meet the Essential Principles
The Therapeutic Goods Administration (TGA) has released Version 3.0 of its user guide, effective from March 2025, " Completing an...
Sharan Murugan
Mar 22, 20252 min read
UK MHRA Guidance: Regulatory Framework for Licensing, Importing, and Supplying Medicines in the UK
The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has issued several guidance documents detailing the licensing,...
Sharan Murugan
Feb 1, 20253 min read
USFDA Guidance: Post-Warning Letter Meetings & Interoperable Exchange of Information
Recently on 05 September 2023, the United States Food & Drug Administration's Center for Drug Evaluation and , Research, Center for...
Sharan Murugan
Sep 10, 20232 min read