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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...

Sharan Murugan

May 23, 20232 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...

Sharan Murugan

May 21, 20231 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...

Sharan Murugan

May 18, 20232 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...

Sharan Murugan

May 13, 20231 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...

Sharan Murugan

May 13, 20232 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...

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...

Sharan Murugan

May 4, 20231 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...

Sharan Murugan

May 2, 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...

Sharan Murugan

Apr 29, 20232 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...

Sharan Murugan

Apr 17, 20231 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",...

Sharan Murugan

Apr 16, 20232 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...

Sharan Murugan

Apr 11, 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...

Sharan Murugan

Apr 5, 20231 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...

Sharan Murugan

Apr 4, 20232 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...

Sharan Murugan

Mar 30, 20231 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...

Sharan Murugan

Mar 30, 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...

Sharan Murugan

Mar 27, 20232 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...

Sharan Murugan

Mar 27, 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...

Sharan Murugan

Mar 24, 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...

Sharan Murugan

Mar 22, 20231 min read