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Regulatory Blogs

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

Showing posts from July 6, 2025Show all
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)

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HSA | Highlights from May 2025: UDI Expansion, SaMD Change Pathway & Key Industry Workshops

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June 20, 2025
EC | New Manufacturer Incident Report (MIR) Form 7.3.1 Published — Mandatory from November 2025

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

June 24, 2025
NMPA | Expanded Scope and GMP Requirements for Domestic Production of Imported Medical Devices in China

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)

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

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

June 24, 2025

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