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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)Â has released Version 3.0Â of its user guide, effective from March 2025, " Completing an...
Sharan Murugan
Mar 222 min read
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UK Medical Device Regulations: Registration and Export Guidelines
Earlier today the Medicines and Healthcare products Regulatory Agency (MHRA)Â released updated guidance " Register medical devices to...
Sharan Murugan
Mar 133 min read
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UK MHRA: Guidance on Licence to Market, Export Drugs, Reclassifing Medicine s & Notifying about a Clinical Investigation for a Medical Device
This week the Medicines and Healthcare Products Regulatory Agency (MHRA) updated multiple guidelines related to medicine and medical...
Sharan Murugan
Mar 20, 20242 min read
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Switzerland's Swissmedic: Med Dev Guidance on Export Certificates and Service Agreement
Yesterday (23 May 2023) Switzerland's Swissmedic released two updated guidances one is "Export Certificates" guidance and another one is...
Sharan Murugan
May 23, 20232 min read
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MHRA Guidance: Export Drugs & Medicine, Active substances Manufactured in GB for use in EEA & NI
The Medicines and Healthcare products Regulatory Agency (MHRA) recently updated a couple of guidances related to Exporting active...
Sharan Murugan
Oct 11, 20221 min read
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SwissMedic Guidance: On Export Certificates
On 1-September, 2022 Swissmedic released the updated guidance on " Guidance document On Export Certificates". Swissmedic issues export...
Sharan Murugan
Sep 4, 20221 min read
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Guidance on Requirements for Import / Re-export Medical Imaging Materials - SFDA
On 27 March,2022 the Saudi Food and Drug Authority (SFDA) released this guidance detailing the Requirements for the Import and Clearance...
Sharan Murugan
Mar 30, 20221 min read
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