MedTech Regulatory Insights May 2025

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Read more at: TGA’s UDI Implementation

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Read more at: ISO 11137-1:2025

Read more at: SAHPRA Official Communication

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Read more at: Implementing Decision (EU) 2025/681

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  • MDR Technical Documentation – Version 3: Provides updated best practices for preparing and submitting Annex II & III documents. Read here
  • IVDR Certification Process: Offers detailed guidance on submission requirements across all certification stages. Read here
  • AI Act and Notified Bodies – Version 2: Highlights the need for harmonised designation of NBs for high-risk AI systems. Read here
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Read More : Market Standing Update

Read More : Risk Classification Draft

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Read more : Explore the Innovation

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Read more: Explore the Innovation

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  • Early Alert: Intravascular PICC Catheter Issue from BD

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Read more at: US FDA Guidance

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