Regulatory Blogs

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

Showing posts with the label Regulatory UpdateShow all
MDA | Malaysia–China Regulatory Reliance Program Pilot for IVD Devices (Phase 1)
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MDA | Malaysia–China Regulatory Reliance Program Pilot for IVD Devices (Phase 1)

Verification Pathway
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
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
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
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
MDA | Updated ASEAN Harmonized Lists for Risk Classification and Borderline Medical Device Products (2025)
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MDA | Updated ASEAN Harmonized Lists for Risk Classification and Borderline Medical Device Products (2025)

Risk Class
NMPA | Expanded Scope and GMP Requirements for Domestic Production of Imported Medical Devices in China
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NMPA | Expanded Scope and GMP Requirements for Domestic Production of Imported Medical Devices in China

Regulatory Update
MDA | Re-Registration Deadline Reminder: Submit via MeDC@St 2.0+ One Year Before Certificate Expiry
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MDA | Re-Registration Deadline Reminder: Submit via MeDC@St 2.0+ One Year Before Certificate Expiry

Regulatory Update
MDA | Updated Guidance on New Registrations Using Expired EC Certificates
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MDA | Updated Guidance on New Registrations Using Expired EC Certificates

Regulatory Update
EC | New Manufacturer Incident Report (MIR) Form 7.3.1 Published — Mandatory from November 2025
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EC | New Manufacturer Incident Report (MIR) Form 7.3.1 Published — Mandatory from November 2025

Regulatory Update
MDA | 65% of Online Medical Device Ads in 2024 Involved Unregistered Products
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MDA | 65% of Online Medical Device Ads in 2024 Involved Unregistered Products

Unregistered Devices
HSA | Transition from MEDICS to SHARE: Key Updates for Medical Device Stakeholders
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HSA | Transition from MEDICS to SHARE: Key Updates for Medical Device Stakeholders

Submission Process