Search
Sharan Murugan
May 23, 20232 min read
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...
31 views0 comments
Sharan Murugan
May 21, 20231 min read
Saudi Arabia’s (SFDA): Requirements on Importation and Shipments of Medical Devices (MDS-REQ5)
Earlier today (21 May 2023) to ensure the importation and shipment of medical devices comply with rigorous standards, the Saudi Food and...
167 views0 comments
Sharan Murugan
May 18, 20232 min read
UK MHRA: Med Dev Guidance on "Off-Label Use","Virtual Mfg." "Legal Requirements" & "Approved Bodies"
UK's Medicines and Healthcare Products Regulatory Agency (MHRA) this week (16,17 May 2023) released updated multiple guidances related...
42 views0 comments
Sharan Murugan
May 13, 20231 min read
EC MDCG: Med Dev Guidance on Significant Changes regarding the Transitional Provision MDR
The European Commission’s Medical Device Coordination Group (MDCG) released updated guidance "Guidance on significant changes regarding...
78 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
May 4, 20231 min read
ICH/USFDA Final Guidance: Q9(R1) Quality Risk Management
Yesterday (03 May, 2023) the United States Food & Drug Administration's Center for Drug Evaluation and Research and Center for Biologics...
61 views0 comments
Sharan Murugan
May 4, 20231 min read
Singapore's HSA: Consultation on eCTD Implementation & Risk Classification on IVD
On 2nd May, 2023 Singapore's Health Sciences Authority (HSA) invited the industry to participate in the consultation on eCTD submissions...
131 views0 comments
Sharan Murugan
May 2, 20232 min read
USFDA Guidance: Decentralized Clinical Trials for Drugs, Biological Products, and Devices
Today (02 May 2023) the United States Food & Drug Administration's Center for Drug Evaluation and Research, Center for Biologics...
16 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...
60 views0 comments
Sharan Murugan
Apr 17, 20231 min read
Swiss Medic: Information sheet on Clinical Investigations with Medical Devices
Recently (13-April-2023) Switzerland's Swissmedic released an updated Information sheet document for "Information sheet on Clinical...
12 views0 comments
Sharan Murugan
Apr 16, 20232 min read
IMDRF Guidance: CyberSecurity, Post-Market Surveillance, Personalized Medical Devices
Recently (IMDRF) released new four technical guidelines, "Personalized Medical Devices – Production Verification and Validation",...
45 views0 comments
Sharan Murugan
Apr 11, 20231 min read
USFDA Q&A: A Risk-Based Approach to Monitoring of Clinical Investigations
Earlier today (11th April 2023) USFDA released final guidance on"A Risk-Based Approach to Monitoring of Clinical Investigations Questions...
32 views0 comments
Sharan Murugan
Apr 5, 20231 min read
USFDA Guidance: Clinical Outcome Assessments Into Endpoints for Regulatory Decision
Earlier today (o5 April 2023) USFDA's Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, and Center...
45 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 30, 20231 min read
USFDA Med Dev: Marketing Submission Recommendations for Change Control Plan for AI/ML Enabled Device
Earlier today (30 March 2023) USFDA released draft guidance on "Marketing Submission Recommendations for a Predetermined Change Control...
57 views0 comments
Sharan Murugan
Mar 30, 20232 min read
USFDA MD Guidance: Cybersecurity-Refuse to Accept Policy for Cyber Devices & Related Systems
Earlier today (30 March 2023) USFDA's Center for Devices and Radiological Health and the Center for Biologics Evaluation and Research...
16 views0 comments
Sharan Murugan
Mar 27, 20232 min read
USFDA Guidance: General Considerations for Animal Studies Intended to Evaluate Medical Devices
Today (27 March 2023) USFDA's Center for Devices and Radiological Health released final guidance on "General Considerations for Animal...
23 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 24, 20231 min read
USFDA MD Guidance: Transition Plan for M.D Issued Emergency Use Authorizations Related to COVID-19
On 24 March 2023, USFDA's Center for Devices and Radiological Health released two final guidances on "Transition Plan for Medical Devices...
17 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...
45 views0 comments