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QT Analysis: World's First Digital Medical Product Act Enforcement Rules Established in Korea  – March/April 2025

QT Analysis: World's First Digital Medical Product Act Enforcement Rules Established in Korea – March/April 2025

  • 2025-03-25 09:14:44

South Korea's newly enacted Digital Medical Products Act (DMPA) establishes a dedicated regulatory framework for AI-driven devices, digital therapeutics, and health apps, ensuring their safety, effectiveness, and quality. Taking effect in January 2025, the Act introduces risk-based classifications, software and cybersecurity requirements, and clear pathways for digital health product approvals, positioning Korea as a global leader in digital health regulation.

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Philippines: A Growing Market Fueled by Universal Health Care Act – March/April 2025

Philippines: A Growing Market Fueled by Universal Health Care Act – March/April 2025

  • 2025-03-26 06:09:21

While the Philippines' ambitious Universal Health Care Act and substantial government investment are creating a rapidly expanding market for medical devices, the nation's overwhelming reliance on imports starkly contrasts with its limited domestic manufacturing capabilities. This situation, however, creates an opening for overseas manufacturers to provide the needed medical devices and take advantage of the increasing market.

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Thailand: Updated Change Notification Guidelines for IVD and Non-IVD: Model Additions/Removals and Amendments to Thai Establishment Information on Labels – March/April 2025

Thailand: Updated Change Notification Guidelines for IVD and Non-IVD: Model Additions/Removals and Amendments to Thai Establishment Information on Labels – March/April 2025

  • 2025-03-25 10:37:19

The Thai FDA updated its change notification guidelines, effective 15 January 2025, focusing on model additions/removals and importer/manufacturer info updates for both IVD and non-IVD devices. The update allows modifications to groupings when adding or removing products within the same application. Additionally, adding models is now classified as a Major Change, requiring an extensive documentation.

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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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See Clearly, Sell Smart: Understanding Japan's Contact Lens Market – February/March 2025

See Clearly, Sell Smart: Understanding Japan's Contact Lens Market – February/March 2025

  • 2025-02-21 05:20:11

Japan's contact lens market is growing rapidly, driven by high myopia rates, aesthetic preferences, and strong domestic demand. A robust network of 2,340+ ophthalmology departments and qualified eye care professionals support the growth of the contact lens market in Japan. Daily disposables dominate this market, supported by a well-established ophthalmology infrastructure. Qualtech offers valuable insights of the Japanese contact lens market in this article, revealing a promising opportunity for foreign manufacturers.

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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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