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Regulatory Blogs
Browse updates and insights on medical device regulations across multiple countries.
Showing posts from June, 2025
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MDA | Updated ASEAN Harmonized Lists for Risk Classification and Borderline Medical Device Products (2025)
Risk Class
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EC | Master UDI-DI Introduced for Highly Individualized Medical Devices
UDI System
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NMPA | Expanded Scope and GMP Requirements for Domestic Production of Imported Medical Devices in China
Regulatory Update
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MDA | Re-Registration Deadline Reminder: Submit via MeDC@St 2.0+ One Year Before Certificate Expiry
Regulatory Update
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MDA | Updated Guidance on New Registrations Using Expired EC Certificates
Regulatory Update
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EC | New Manufacturer Incident Report (MIR) Form 7.3.1 Published — Mandatory from November 2025
Regulatory Update
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MDA | 65% of Online Medical Device Ads in 2024 Involved Unregistered Products
Unregistered Devices
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HSA | Transition from MEDICS to SHARE: Key Updates for Medical Device Stakeholders
Submission Process
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MDA | Industry Commitment & Regulatory Action Reinforce Medical Device Safety in Malaysia
Regulatory Update
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HSA | Highlights from May 2025: UDI Expansion, SaMD Change Pathway & Key Industry Workshops
UDI
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Popular Posts
EC | New Manufacturer Incident Report (MIR) Form 7.3.1 Published — Mandatory from November 2025
June 24, 2025
HSA | Highlights from May 2025: UDI Expansion, SaMD Change Pathway & Key Industry Workshops
June 20, 2025
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
MDA | 65% of Online Medical Device Ads in 2024 Involved Unregistered Products
June 24, 2025
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