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Qualtech's Silver Jubilee: Highlights of 2024 and the Vision for 2025 – January/February 2025

Qualtech's Silver Jubilee: Highlights of 2024 and the Vision for 2025 – January/February 2025

  • 2025-01-22 09:19:30

In 2024, Qualtech Consulting Corporation achieved significant milestones, including expanding our services to support Korean MFDS registrations, celebrating the 10th anniversary of our Malaysian office, and hosting impactful webinars addressing regulatory and market opportunities in Europe, ASEAN, Brazil, and India. As we prepare for 2025, we are focused on expanding knowledge-sharing efforts, entering emerging markets such as Latin America and the Middle East, and celebrating 25 years of supporting medical device manufacturers globally.

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Greying Korea: Can MedTech Devices Beat the Chronic Disease Wave? – January/February 2025

Greying Korea: Can MedTech Devices Beat the Chronic Disease Wave? – January/February 2025

  • 2025-01-22 07:51:43

South Korea's rapidly aging population is driving a surge in chronic diseases, creating a lucrative market for medical devices. This article will highlight the growing demand for diagnostic tools, remote patient monitoring devices, wearable health trackers, cardiovascular and orthopedic devices, and diabetes care devices. With significant market projections, South Korea offers promising opportunities for foreign medical device manufacturers.

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Australia: Understanding the Therapeutic Goods Administration's (TGA) Recall Reforms and the Introduction of the PRAC – January/February 2025

Australia: Understanding the Therapeutic Goods Administration's (TGA) Recall Reforms and the Introduction of the PRAC – January/February 2025

  • 2025-01-22 07:36:15

The Therapeutic Goods Administration (TGA) has introduced the Procedure for Recalls, Product Alerts, and Product Corrections (PRAC) to streamline and enhance the recall processes for therapeutic goods in Australia. By reducing recall categories, simplifying procedural steps, and improving communication, the PRAC aims to foster efficiency and clarity for manufacturers and regulatory consultants. With implementation set for March 2025, stakeholders are encouraged to prepare for these reforms to ensure compliance and contribute to a safer therapeutic goods landscape.

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Singapore: Pilot Run: Change Management Program (CMP) for SaMD, including Machine Leaning-enabled SaMD – January/February 2025

Singapore: Pilot Run: Change Management Program (CMP) for SaMD, including Machine Leaning-enabled SaMD – January/February 2025

  • 2025-01-22 03:51:46

Medical Device Cluster (MDC) is rolling out the pilot run for the Change Management Program (CMP) for Software as Medical Device (SaMD), also known as a Standalone medical mobile application, including Machine Learning-Enabled SaMD. The program is voluntary and incorporated into HSA's existing Premarket Product Registration and Change Notification process. With effect from 4 December 2024, HSA also published new guidance document (GN-37) for the program.

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Vietnam: MOH Updates Medical Device Regulations: Extended Validity Periods Explained – January/February 2025

Vietnam: MOH Updates Medical Device Regulations: Extended Validity Periods Explained – January/February 2025

  • 2025-01-22 03:13:13

On January 1st, 2025, the Vietnam Ministry of Health issued Decree No. 04/2025/NĐ-CP, extending the validity of import licenses for medical devices until June 30, 2025. This decree updates Clause 2, 3, and 4 of Article 76 in Decree No. 98/2021/ND-CP, as amended by Decree No. 07/2023/ND-CP. These changes aim to allow businesses to continue operations without interruption and ensure smooth operations in medical device management.

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