• 2025-02-20 11:17:07

From January 4, 2025, onwards, Thai FDA has tightened medical device advertising rules to prevent misleading claims. Advertisements must align with approved product information, specify target audiences, and include required disclaimers. Stricter enforcement measures target misleads advertising, especially for dermal fillers. Likewise Consumers shall verify approved products on the Thai FDA's website, updated on a weekly bases.

• 2025-02-20 11:06:06

The Thai FDA has launched a priority track for 6 types of medical devices targeting Non-Communicable Diseases (NCDs), enabling faster approval for essential healthcare solutions. This initiative is designed to ensure quicker access to vital healthcare solutions, providing medical device companies with faster market entry for devices targeting public health challenges.

• 2025-02-20 10:48:19

In 2025, the Thai FDA reinstated the auto approval system for specific Class 1 medical devices with additional conditions. The new "Positive List" identifies eligible devices by their GMDN generic names, expediting approvals while others require manual review.

• 2025-02-20 10:32:57

The FDA has released a draft on lifecycle management and marketing submission recommendations for devices that include AI-enabled software functions. This draft incorporates the Total Product Life Cycle (TPLC) approach and guiding principles for Good Machine Learning Practice (GMLP).

• 2025-02-20 10:09:30

Decree No. 04/2025/NĐ-CP, released on January 1st, 2025, by Vietnam MOH, extending the validity of import license until June 30, 2025, on the Decree amending and supplementing of Clause 2, Clause 3, and Clause 4, Article 76 of Decree No. 98/2021/ND-CP, as revised by Decree No. 07/2023/ND-CP, regarding medical device management.

• 2025-01-20 06:54:39

Register our FREE Webinar on 2025 Updates & Forecast for European Medical Device Regulations. Keep your medical device compliance in Europe up-to-date!

• 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.

• 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.

• 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.

• 2025-01-22 07:16:29

This guidance provides detailed instructions on assigning Master Unique Device Identification Device Identifiers (Master UDI-DIs) to contact lenses.