Regulatory Blogs

Browse updates and insights on medical device regulations across multiple countries.

Showing posts from July, 2025Show all
MDA | Malaysia–China Regulatory Reliance: A World-First Milestone
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MDA | Malaysia–China Regulatory Reliance: A World-First Milestone

Verification Pathway
EC | Timelines Confirmed for Master UDI-DI Implementation to Optical Medical Devices
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EC | Timelines Confirmed for Master UDI-DI Implementation to Optical Medical Devices

UDI
MHRA | UK to Adopt EU Common Specifications for High-Risk IVD Devices
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MHRA | UK to Adopt EU Common Specifications for High-Risk IVD Devices

United Kingdom
HSA | GN-21 Guidance on Change Notification Updated for Clarity and Scope
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HSA | GN-21 Guidance on Change Notification Updated for Clarity and Scope

UDI Submission
TGA | Australia Introduces New Regulations to Enhance Medical Device Patient Safety
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TGA | Australia Introduces New Regulations to Enhance Medical Device Patient Safety

Unique Device Identification
EC | Electronic Instructions for Use Now Allowed for Medical Devices Across the EU
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EC | Electronic Instructions for Use Now Allowed for Medical Devices Across the EU

Sustainability
MDA | MedC@St 2.0+ Introduces Login via MyDigital ID for Enhanced Security
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MDA | MedC@St 2.0+ Introduces Login via MyDigital ID for Enhanced Security

SSO
HSA | “SHARE” Launches 14 July – The New Digital Portal for Medical Device Submissions
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HSA | “SHARE” Launches 14 July – The New Digital Portal for Medical Device Submissions

Singapore
EC | FAQ on the Interplay Between MDR/IVDR and the Artificial Intelligence Act (MDCG 2025-6)
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EC | FAQ on the Interplay Between MDR/IVDR and the Artificial Intelligence Act (MDCG 2025-6)

Regulatory Update
EC | Q&A Guidance on Performance Studies for In Vitro Diagnostic Devices Under IVDR (MDCG 2025-5)
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EC | Q&A Guidance on Performance Studies for In Vitro Diagnostic Devices Under IVDR (MDCG 2025-5)

Regulatory Update
EC | Revised Guidance on Qualification and Classification of Software Under MDR & IVDR (MDCG 2019-11 Rev.1)
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EC | Revised Guidance on Qualification and Classification of Software Under MDR & IVDR (MDCG 2019-11 Rev.1)

Software Classification
MHRA | New Post-Market Surveillance (PMS) Regulation Comes into Force Across Great Britain
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MHRA | New Post-Market Surveillance (PMS) Regulation Comes into Force Across Great Britain

United Kingdom
EC | Guidance Released on Safe Making Medical Device Software (MDSW) Apps Available on Online Platforms
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EC | Guidance Released on Safe Making Medical Device Software (MDSW) Apps Available on Online Platforms

Software Apps