• 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.

• 2024-12-16 09:17:34

The updated Therapeutic Goods regulations in Australia, effective October 19, 2024, introduce streamlined documentation for medical devices assessed by the US FDA. By aligning with international standards, the changes simplify compliance for Class IIa and Class III devices, reducing burdens while ensuring safety and quality, offering manufacturers faster market access.

• 2024-12-16 07:05:36

Thai FDA has updated its guidance on the registration of Software as a Medical Device (SaMD) and Artificial Intelligence (AI) medical devices. Key revisions include new requirements for establishment licensing, compliance with advertising regulations, and enhanced cybersecurity measures. The updated guidance offers stakeholders a clear framework for classification criteria, document preparation, and post-market responsibilities.

• 2024-11-04 08:50:30

Thai FDA introduced new guidelines for handling the registration of medical devices under Notified (Class 2 & 3) and Licensed (Class 4) Medical Device. Thai FDA permitted referencing of previously approved dossiers when applying for brand name changes ("Refer") and for the transfer of medical device licenses between medical device establishment ("Transfer"). This move aimed to streamline the regulatory process, reduce redundant dossier reviews, and simplify licensing in Thailand's medical device sector.

• 2024-10-10 08:23:53

The Thai Food and Drug Administration (FDA) has initiated a registration process for Mpox diagnostic test kits in response to rising concerns over the spread of the viral infection. This move aims to enhance early detection and management of Mpox cases, ensuring public health safety. The Thai FDA has streamlined the registration process for manufacturers and importers, focusing on quality and accuracy of the diagnostic kits. This initiative is a key step in Thailand's efforts to curb the spread of the virus and strengthen its response to emerging health threats.

• 2024-10-10 08:07:48

The FDA launched the Voluntary Malfunction Summary Reporting (VMSR) program in 2018 to streamline the malfunction reporting process for medical device manufacturers. This initiative enhances the FDA's capacity to effectively monitor a diverse array of devices.

• 2024-09-17 02:22:43

The Thai FDA has announced significant regulatory changes to accelerate the approval process for medical device manufacturing and importation. Effective June 6, 2024, these changes aim to reduce redundancy in documentation without compromising product safety or quality. This streamlined approach is expected to foster innovation, attract foreign investment, and enhance Thailand's position as a regional healthcare hub.