• 2025-02-21 04:28:54

The NMPA's new IVD Reagent Classification Catalog, effective January 1, 2025, introduces a standardized classification code format for streamlined registration. The update replaces the previous system, requiring compliance with the "6840-XX-XXXXX" format and providing guidelines for multiplex and unclassified products. Early preparation is essential to avoid approval delays.

• 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.

• 2025-01-22 06:13:50

Administrative Order No. 2024-0016 sets a new schedule of fees and charges by the Food and Drug Administration (FDA) of the Philippines for all regulated products, including medical devices, drugs, food, and cosmetics. The updated fees aim to simplify compliance for manufacturers and distributors while keeping pace with the growing demands of the healthcare industry. This change ensures more efficient processes for licensing, product registration, and market access.

• 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.