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Regulatory Blogs
Browse updates and insights on medical device regulations across multiple countries.
Showing posts from June 25, 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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