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Sharan Murugan
Dec 3, 20231 min read
UK MHRA: Guidance on Register Medical Devices to Place on the Market
Last Friday on 1st December 2023 UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "Register...
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Sharan Murugan
Nov 18, 20232 min read
UK MHRA: Guidance on Change of Ownership: Marketing Authorisation Process
Last Friday (17 November 2023) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "Medicines...
162 views0 comments
Sharan Murugan
Nov 7, 20231 min read
MHRA Guidance: Common Issues Identified during Clinical Trial Applications
Yesterday (06 November 2023) the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "Common...
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Sharan Murugan
Oct 25, 20231 min read
UK MHRA: Guidance on Software and Artificial Intelligence (AI) as a Medical Device
Earlier today (25 October 2023) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated Guidance on "Software...
37 views0 comments
Sharan Murugan
Oct 21, 20231 min read
UK MHRA Guidance: Apply for a Licence to Market a Medicine in the UK
Last Thursday (19 October 2023) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "Apply for a...
55 views0 comments
Sharan Murugan
Oct 14, 20232 min read
UK MHRA: Clinical Trials for Medicines: Apply for Authorisation in the UK
Recently (12 October 2023) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "Clinical Trials...
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Sharan Murugan
Sep 25, 20232 min read
MHRA MD Guidance: Innovative Devices Access Pathway (IDAP) & How to Notify Clinical Investigation
Recently the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "The Innovative Devices Access...
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Sharan Murugan
Sep 9, 20231 min read
UK MHRA: Guidance on International Recognition Procedure
Recently the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released a guidance on "International Recognition Procedure"...
72 views0 comments
Sharan Murugan
Jul 30, 20232 min read
UK MHRA: Guidance on Labelling & Packaging of Medicinal Products - Windsor Framework
On 27 July 2023 UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "Labelling and packaging of...
194 views0 comments
Sharan Murugan
Jul 17, 20231 min read
MHRA Med Dev Guidance: In-Vitro Diagnostic Medical Devices on Legislation
Earlier today (17 July, 2023) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "The...
25 views0 comments
Sharan Murugan
Jul 2, 20231 min read
UK MHRA MD Guidance: Borderlines with Medical Devices & Other Products in Great Britain
Yesterday(01 July 2023) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidelines on the "Borderlines...
32 views0 comments
Sharan Murugan
Jun 27, 20231 min read
UK MHRA Guidance: Clinical Trials for Medicines: Apply for Authorisation in the UK
Yesterday (27 June 2023) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "Clinical Trials...
47 views0 comments
Sharan Murugan
Jun 17, 20231 min read
MHRA Guidance: 150-Day Assessment for National Applications & Parallel Import Licence
Recently (09 May 2023) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on the "150-Day...
78 views0 comments
Sharan Murugan
May 13, 20232 min read
UK MHRA: Guidance on Qualified Person responsible for QPPV & PSMF
Last Thursday (11 May 2023) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated "Guidance on the qualified...
64 views0 comments
Sharan Murugan
May 13, 20232 min read
UK MHRA Guidance: Notifying MHRA on a Clinical Investigation for a Medical Device
Last Thursday (11 May 2023) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated Guidance on "Notify the MHRA...
39 views0 comments
Sharan Murugan
Apr 29, 20232 min read
MHRA Guidance: Registration & Regulating Medical Devices in UK
Yesterday (28 April 2023) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "Regulating...
62 views0 comments
Sharan Murugan
Apr 9, 20231 min read
UK MHRA: Guidance on Good Clinical Practice for Clinical Trials
The Medicines and Healthcare Products Regulatory Agency (MHRA) recently (06 April 2023) released updated guidance on "Good Clinical...
178 views0 comments
Sharan Murugan
Apr 4, 20232 min read
UK MHRA: MHRA Fees 2023 & Guidance on How to Draft a Direct Health Care Professional Communication
Statutory guidance on MHRA fees A new statutory fee for MHRA services was introduced on April 1, 2023, by the Medicines and Healthcare...
30 views0 comments
Sharan Murugan
Mar 27, 20231 min read
UK MHRA: Guidance on Register Medical Devices to place on the Market
Earlier today (27 March 2023) UK's Medicines and Healthcare products Regulatory Agency (MHRA) released updated guidance on "Register...
109 views0 comments
Sharan Murugan
Mar 22, 20231 min read
UK MHRA: MD Guidance on Crafting an Intended Purpose in the Context of SaMD
Earlier today (22 March 2023) UK Medicines and Healthcare products Regulatory Agency released updated guidance on "Crafting an intended...
49 views0 comments