Regulatory Blog

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Mar 202 min read

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...

Aug 22, 20232 min read

Australia's TGA: Reclassification of Medical Devices & Variations to Prescription Medicines

Yesterday (21-August-2023) Australia's Therapeutic Goods Administration (TGA) released multiple guidances on the "Reclassification of...

Jul 2, 20232 min read

Australia's TGA: Reclassification of Surgical Mesh, Spinal Implants & Completing a Notification Form

Recently on 27th June, 2023 Australia's Therapeutic Goods Administration (TGA) released multiple guidances on the "Reclassification of...

Oct 22, 20222 min read

UK MHRA Guidance: Register to Manufacture, Import or Distribute Act.Sub, & Reclassify Products

The Medicines and Healthcare products Regulatory Agency (MHRA) recently updated a few guidances related to registration &...

Aug 4, 20221 min read

UK MHRA Guidance: Medicines: How to Reclassify your Product

Today (August 4, 2022) UK Medicines and Healthcare products Regulatory Agency (MHRA) updated its guidance for the industry, “Guidance:...