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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...
Sharan Murugan
Dec 3, 20231 min read
20 views
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Australia TGA: Clinical Evidence Guidelines
The Australian Regulatory Guidelines for Medical Devices (ARGMD) released updated guidance "Clinical Evidence" on 23 November 2023,...
Sharan Murugan
Nov 26, 20232 min read
32 views
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Swiss Medic: Biosimilar Authorisation Guidance
Swissmedic, the Swiss Agency for Therapeutic Products, published an updated guidance on (26 November 2023) the "Guidance document...
Sharan Murugan
Nov 26, 20232 min read
38 views
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South Africa's (SAPHRA): Questions And Answers Licensing Of Medical Device Establishments
Last Friday (17 November 2023) the South African Health Products Regulatory Authority (SAPHRA) released updated guidance on "Guideline On...
Sharan Murugan
Nov 19, 20231 min read
36 views
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USFDA MD Guidance: Notifying FDA of a Permanent Discontinuance, 506J Guidance & Computational Model
USFDA's Center for Devices and Radiological Health and Center for Biologics Evaluation and Research released multiple guidances related...
Sharan Murugan
Nov 19, 20232 min read
15 views
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Switzerland's SwissMedic: Guidance on Formal Requirements
On 15 November 2023, Switzerland's Swissmedic released an updated guidance on "Formal Requirements" which serves as a resource for...
Sharan Murugan
Nov 15, 20232 min read
38 views
0 comments
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...
Sharan Murugan
Nov 7, 20231 min read
43 views
0 comments
USFDA MD Guidance: Enforcement Policy for Clinical Electronic Thermometers
Last Friday (03 November 2023) the U.S. Food and Drug Administration (FDA) released two draft guidance "Enforcement Policy for Clinical...
Sharan Murugan
Nov 5, 20231 min read
9 views
0 comments
USFDA Guidance: Supplements for Approved Premarket Approval or Humanitarian Device Exemption
Today (02 November, 2023) the U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research Center for Devices and...
Sharan Murugan
Nov 2, 20231 min read
20 views
0 comments
TGA Guidance: General Dossier Requirements
Recently on 27th October, 2023 Australia's Therapeutic Goods Administration (TGA) released an updated guidance on the "General Dossier...
Sharan Murugan
Oct 31, 20231 min read
219 views
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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...
Sharan Murugan
Oct 25, 20231 min read
42 views
0 comments
USFDA MD Guidance: Enforcement Policy for Non-Invasive Remote Monitoring Devices
The U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health released a final guidance "Enforcement Policy for...
Sharan Murugan
Oct 23, 20231 min read
18 views
0 comments
USFDA MD Guidance: Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices
Recently (10th October 2023) the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health released multiple...
Sharan Murugan
Oct 14, 20231 min read
11 views
0 comments
USFDA MD Guidance: AST System Devices, Technical Considerations & Electronic Submission Template
Recently (29th September 2023) the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health released multiple...
Sharan Murugan
Oct 2, 20232 min read
13 views
0 comments
USFDA MD Guidance: Cybersecurity-Quality System Considerations & Content of Premarket Submissions
The U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health released a final guidance "Cybersecurity in...
Sharan Murugan
Oct 2, 20231 min read
7 views
0 comments
EC Q&A Guidance: Questions & Answers: Clinical Trials Regulation
Recently this Friday (29-Sepetember, 2023), the European Commission's Clinical Trials Coordination and Advisory Group released an updated...
Sharan Murugan
Oct 2, 20232 min read
114 views
0 comments
EMA Guidance: Pre-Authorisation Procedural Advice for Users of the Centralised Procedure
Last Friday (29 September 2023) the European Medicines Agency released an updated guidance on "European Medicines Agency...
Sharan Murugan
Oct 2, 20231 min read
35 views
0 comments
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...
Sharan Murugan
Sep 25, 20232 min read
25 views
0 comments
USFDA Guidance: Conduct of Clinical Trials of Medical Products During Major Disruptions
Today (21 September 2023) CDER, along with the FDA Center for Biologics Evaluation and Research, Center for Devices and Radiological...
Sharan Murugan
Sep 21, 20231 min read
27 views
0 comments
USFDA Guidance: Regulatory Considerations for Prescription Drug Use-Related Software
Yesterday (19 September 2023) the U.S. Food and Drug Administration (FDA) released two draft guidance "Regulatory Considerations for...
Sharan Murugan
Sep 20, 20232 min read
26 views
0 comments