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Regulatory Blogs
Browse updates and insights on medical device regulations across multiple countries.
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Digital Health
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TGA | Australia Introduces New Regulations to Enhance Medical Device Patient Safety
Unique Device Identification
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EC | Electronic Instructions for Use Now Allowed for Medical Devices Across the EU
Sustainability
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EC | FAQ on the Interplay Between MDR/IVDR and the Artificial Intelligence Act (MDCG 2025-6)
Regulatory Update
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EC | Revised Guidance on Qualification and Classification of Software Under MDR & IVDR (MDCG 2019-11 Rev.1)
Software Classification
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EC | Guidance Released on Safe Making Medical Device Software (MDSW) Apps Available on Online Platforms
Software Apps
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HSA | Transition from MEDICS to SHARE: Key Updates for Medical Device Stakeholders
Submission Process
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HSA | Highlights from May 2025: UDI Expansion, SaMD Change Pathway & Key Industry Workshops
UDI
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Popular Posts
NMPA | Expanded Scope and GMP Requirements for Domestic Production of Imported Medical Devices in China
June 27, 2025
MDA | Updated ASEAN Harmonized Lists for Risk Classification and Borderline Medical Device Products (2025)
June 29, 2025
EC | New Manufacturer Incident Report (MIR) Form 7.3.1 Published — Mandatory from November 2025
June 24, 2025
MDA | Industry Commitment & Regulatory Action Reinforce Medical Device Safety in Malaysia
June 21, 2025
HSA | Highlights from May 2025: UDI Expansion, SaMD Change Pathway & Key Industry Workshops
June 20, 2025
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