MHRA Clinical Investigations Guidance for Medical Devices
The UK has updated its guidance on notifying the Medicines and Healthcare products Regulatory Agency (MHRA) about…
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Swissdamed Database Launch: August 2024 Update
Swissmedic has recently announced the first module of the Swissdamed Medical Devices Database will go live on…
MDCG 2021-5 Guidance: Standardization for Medical Devices
As of July 2nd, 2024, MDCG 2021-5 Rev.1 – Guidance on Standardization for Medical Devices, has been…
TGA Software Guidance: Regulations and Exclusions
There was a new guidance released by The Australian Therapeutic Goods Administration (TGA) which aims to…
TGA Classification Tool for Medical Devices and IVDs
The Australian Therapeutic Goods Administration (TGA) has released an online classification tool to help medical…
AI/ML Good Machine Learning Practices
A new draft guidance was issued by Artificial Intelligence/Machine Learning-enabled Working Group, with comments welcomed until Friday…
IMDRF Announces non-IVD MA ToC Updates
The International Medical Device Regulators Forum (IMDRF) have released several key updates and reorganization changes to the…
ARTG Exemptions for Certain Medical Devices
The Australian Therepeutic Good Administration (ARTG) has announced exemptions for certain medical devices …
FDA Final Ruling on LDTs (Laboratory Developed Tests)
T…
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