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Sharan Murugan
May 25, 20242 min read
EMA Med Dev. Guidance: New Guidance for Industry and Notified Bodies
The European Medicines Agency (EMA) has recently released updated Q&A guidelines "New Guidance for Industry and Notified Bodies" that...
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Sharan Murugan
May 18, 20242 min read
UK MHRA: "AI Airlock" The Regulatory Sandbox for AIaMD
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has introduced (09 May, 2024) the “AI Airlock - The Regulatory Sandbox...
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Sharan Murugan
May 14, 20242 min read
Australia TGA: Regulation of Software based Medical Devices
On 9th May 2023 Australia's Therapeutic Goods Administration (TGA) released an updated "Regulation of Software-based Medical Devices"...
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Sharan Murugan
May 11, 20241 min read
USFDA Med Dev: Guidance on Remanufacturing of Medical Devices
Recently (09 May, 2024) the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health released the...
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Sharan Murugan
May 6, 20242 min read
USFDA MD Guidance: Enforcement Policies for Tests During a Section 564 Declared Emergency & for Certain In Vitro Diagnostic Devices
Today (06 May 2024) the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health released two draft guidances...
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Sharan Murugan
May 6, 20242 min read
UK MHRA: Guidance on Software and Artificial Intelligence (AI) as a Medical Device
Last Friday (03 May 2024) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "Software and...
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Sharan Murugan
May 1, 20242 min read
Australia TGA: Regulatory requirements for in-house IVDs
Today (01 May 2024) Australia's Therapeutic Goods Administration (TGA) released updated guidance "Regulatory requirements for in-house...
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Sharan Murugan
Apr 27, 20242 min read
UK MHRA: Notify MHRA About a Clinical Investigation for a Medical Device
Yesterday (26 April 2024) the UK Medicines and Healthcare Products Regulatory Agency (MHRA) updated its guidance "Notify MHRA About a...
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Sharan Murugan
Apr 20, 20242 min read
MDCG Guidance: In-Vitro Diagnostic Medical Device Safety Reporting
The European Commission’s Medical Device Coordination Group (MDCG) released updated guidance "Safety reporting in performance studies of...
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Sharan Murugan
Apr 13, 20242 min read
UK MHRA Guidance: Borderlines with Medical Devices & Other Products in Great Britain
The UK Medicines and Healthcare Products Regulatory Agency (MHRA) updated its guidance "Borderlines with Medical Devices & Other Products...
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Sharan Murugan
Apr 7, 20242 min read
Switzerland's SwissMedic: Guidance on Export Certificates
On 3rd April, 2024 Switzerland's Swissmedic released an updated "Guidance on Export Certificates" and as part of its regulatory...
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Sharan Murugan
Mar 30, 20242 min read
South Africa SAPHRA: Guideline For Professional Information For Human Medicines (Categories A and D) and Classification of Medical Devices and IVDs
Recently last week the South African Health Products Regulatory Authority (SAPHRA) released an updated "Guideline For Professional...
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Sharan Murugan
Mar 25, 20242 min read
UK MHRA: Guidance on Regulation of devices in Northern Ireland & Apply for Manufacturer or Wholesaler of Medicines Licences
Earlier today (25 March 2025) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "Apply for...
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Sharan Murugan
Mar 20, 20242 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...
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Sharan Murugan
Mar 13, 20241 min read
USFDA Med.Dev: Draft Guidance Select Updates for the Premarket Cybersecurity -Section 524B of the FD&C Act
Today (13 March, 2024) the U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research Center for Devices and...
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Sharan Murugan
Mar 2, 20242 min read
USFDA Guidance: Reporting Amount of Listed Drugs and Biological Product and Key Information and Facilitating Understanding in Informed Consent Guidance
Earlier this week (26 & 29 February 2024) the the U.S. Food and Drug Administration (FDA)Â released two guidances "Reporting Amount of...
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Sharan Murugan
Feb 22, 20241 min read
TGA MD Guidance: Medical Device Labelling Obligations
On Monday (19 February, 2024) Australia's Therapeutic Goods Administration (TGA) released updated guidance on the "Medical Device...
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Sharan Murugan
Feb 13, 20242 min read
USFDA Guidance: Use of Data Monitoring Committees in Clinical Trials
Today (13 February 2024) the U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research, Center for Devices...
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Sharan Murugan
Feb 4, 20242 min read
USFDA Guidance: "Understanding FDA's QMSR Final Rule: What You Need to Know for the Transition Period"
The U.S. Food and Drug Administration (FDA) plays a crucial role in ensuring the safety and effectiveness of medical devices. In pursuit...
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Sharan Murugan
Jan 31, 20241 min read
USFDA Guidance: Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products
FDA announced on Monday (29-January-2024) that a draft guidance for the industry is available titled, "Collection of Race and Ethnicity...
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