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Australia: Unique Device Identification (UDI) Requirements: What Medical Device Manufacturers Must Know for Compliance in 2025–2030 – April/May 2025

Australia: Unique Device Identification (UDI) Requirements: What Medical Device Manufacturers Must Know for Compliance in 2025–2030 – April/May 2025

  • 2025-04-24 06:13:27

Australia’s implementation of the Unique Device Identification (UDI) system marks a major advancement in medical device traceability and regulatory oversight. This article provides medical device manufacturers with essential guidance on the TGA’s UDI requirements, timelines, and compliance obligations from 2025 through 2030. It also outlines key roles, exemptions, and actionable strategies to support successful market access and patient safety.

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China: Announcement of the National Medical Products Administration on Further Adjusting and Optimizing Matters Related to the Production of Imported Medical Devices by Domestic Enterprises in China (No. 30 of 2025) – April/May 2025

China: Announcement of the National Medical Products Administration on Further Adjusting and Optimizing Matters Related to the Production of Imported Medical Devices by Domestic Enterprises in China (No. 30 of 2025) – April/May 2025

  • 2025-04-24 07:49:13

The National Medical Products Administration has further adjusted and optimized certain provisions of the Announcement on Matters Concerning the Production of Imported Medical Device Products by Domestic Enterprises in China, originally issued in September 2020.

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Singapore: Public Consultation on Best Practices Guide for Medical Device Cybersecurity – April/May 2025

Singapore: Public Consultation on Best Practices Guide for Medical Device Cybersecurity – April/May 2025

  • 2025-04-24 08:42:19

HSA's Medical Devices Cluster has released a draft on Best Practices Guide for Medical Device Cybersecurity for stakeholder consultation. The document provides recommendations on cybersecurity best practices for medical devices, focusing on both pre-market and post-market stages of the device's Total Product Lifecycle (TPLC).

This document is targeted for Medical Device Manufacturers and Healthcare providers, and currently available as a draft for consultation. Which opens from 10 March 2025 to 12 May 2025. The feedback can be submitted by filling out the provided template and upload to the established link.

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QT Activity: 2025 Updates & Forecast for European Medical Device Regulations Webinar Summary Recap – February/March 2025

QT Activity: 2025 Updates & Forecast for European Medical Device Regulations Webinar Summary Recap – February/March 2025

  • 2025-02-21 05:38:28

Qualtech hosted a webinar providing key insights into the evolving European medical device regulations. The discussion covered essential updates, including the MDR transition period extension, Article 10A supply notification requirements, the gradual rollout of EUDAMED, the implications of the European AI Act, and regulatory changes in the UK and Switzerland. Attendees gained valuable guidance on compliance strategies and proactive measures to navigate these regulatory shifts.

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Australia: TGA Updates Application Audit Rules for Medical Devices and IVDs: What Manufacturers Need to Know – February/March 2025

Australia: TGA Updates Application Audit Rules for Medical Devices and IVDs: What Manufacturers Need to Know – February/March 2025

  • 2025-02-21 05:10:50

The Therapeutic Goods Administration (TGA) has updated its application audit guidance for medical devices and in-vitro diagnostics (IVDs), to streamline regulatory processes and focus on high-risk devices. Additionally, the transition from the EU In Vitro Diagnostic Directive (IVDD) to the In Vitro Diagnostic Regulation (IVDR) introduces stricter requirements and extended transition periods for compliance. Medical device manufacturers must ensure thorough documentation and timely submissions to meet these evolving standards.

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INDONESIA: RECLASSIFICATION OF FILTER PAPER AS A MEDICAL DEVICE – February/March 2025

INDONESIA: RECLASSIFICATION OF FILTER PAPER AS A MEDICAL DEVICE – February/March 2025

  • 2025-02-21 03:51:47

Indonesia's Ministry of Health has reclassified Filter Paper, specifically Dried Blood Spot (DBS) Filter Paper, as a Medical Device. This significant change, effective December 9, 2024, requires manufacturers to register their products as medical devices through the Online Single Submission (OSS) system. This reclassification necessitates compliance with specific regulations and quality standards, impacting product registration and market access in Indonesia.

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