MHRA’s New Fee Structure: What It Means for Manufacturers
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has announced significant changes to its statutory…
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Manual on Borderline and Classification Under the IVDR and MDR
The Borderline and Classification Working Group (BCWG) has released Version 4 (September 2025) of the Manual…
MHRA Designated Standards Survey Newly Launched
On September 5th, the UK Medicines and Healthcare products Regulatory Agency (MHRA) launched a designated standards survey to identify which…
CE Marking Support: MedEnvoy Partnership
At MedEnvoy, we take pride in helping innovative companies bring their medical devices to market with confidence, with CE marking…
Updated TGA Essential Principles Checklist
The Therapeutic Goods Administration (TGA) has released an updated version of the Essential Principles (EP) checklist for medical devices and…
EU Launches Evidence on Targeted Revision of MDR and IVDR
The European Commission has launched a Call for Evidence on the planned targeted revision of the Medical Device Regulation (MDR,…
TGA Publishes List of AI-Enabled Medical Devices
On 4 September 2025, the Therapeutic Goods Administration (TGA) released a public list of medical devices…
Importing Medical Devices to India: Compliance Mistakes to Avoid
Medical device manufacturers with registrations in India often encounter compliance roadblocks during the importation process, even after a successful regulatory…
TGA Focuses on AI and Software-Based Medical Devices
The Therapeutic Goods Administration (TGA) has published a new regulatory focus on artificial intelligence (AI) and other software-based medical devices.
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