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WHO Guidance: Ethics and Governance of Artificial Intelligence for Health

The World Health Organization (WHO) released new guidelines (18 January 2023) on ethics and governance of large multi-modal models...

Sharan Murugan

Jan 20, 20241 min read

MHRA Guidance: Notify the MHRA about a Clinical Investigation for a Medical Device

Earlier today (17 July, 2024) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "Notify the...

Sharan Murugan

Jan 16, 20242 min read

South Africa's (SAPHRA): Import Applications Of Electronic Devices Emitting Ionizing Radiation

Earlier today (16 January, 2024) the South African Health Products Regulatory Authority (SAPHRA) released an updated Guideline For...

Sharan Murugan

Jan 16, 20241 min read

USFDA Guidance: Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions

Yesterday (08 January, 2024) the U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research Center for Devices...

Sharan Murugan

Jan 9, 20241 min read

India CDSCO: Launching of National Single Window System (NSWS) Portal

To address the challenges in the management of medical devices, India's Central Drugs Standard Control Organization (CDSCO) has...

Sharan Murugan

Jan 2, 20241 min read

Saudi Arabia’s (SFDA): Requirements for Clinical Trials of Medical Devices

The Saudi Food and Drug Authority (SFDA) issued a comprehensive updated guidance titled "Requirements for Clinical Trials of Medical...

Sharan Murugan

Dec 30, 20231 min read

USFDA MD Guidance: Use of RWE to Support Regulatory Decision-Making forMedical Devices

Recently (14 December 2023) the U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research Center for Devices...

Sharan Murugan

Dec 19, 20232 min read

Philippines FDA: Guidance on Use of FDA eServices Portal for the Initial Application of CMDN

On 4 Decemberber 2023, the Philippines FDA released draft guidelines on the "Use of the Food and Drug Administration eServices Portal...

Sharan Murugan

Dec 6, 20232 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...

Sharan Murugan

Dec 3, 20231 min read

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

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

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

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

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

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

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

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

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

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

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