• 2025-11-26 07:23:46

This article summarizes key insights from Qualtech's 2025 ASEAN regulatory webinar, highlighting major updates in Indonesia, Thailand and Vietnam. The recap covers changes in retail rules, procurement, halal enforcement, reliance pathways and registration procedures, reflecting how these markets are streamlining medical device approvals and improving regional market access.

• 2025-10-27 04:49:01

To simplify preparation and expedite event organization, the Thai FDA announced that no advertising license is required for presenting medical devices at national, or international academic exhibitions and conferences. Academic events that meet the specified conditions may qualify for this exemption.

• 2025-10-27 04:30:17

List of selected frequently asked questions regarding the renewal of the medical device approval certificates. Originally in Thai, this English version offers practical guidance for maintaining compliance with Thai FDA requirements.

• 2025-10-27 03:54:41

The Thai FDA joined forces with the CPPD Police raided a warehouse in Samut Prakan Province and discovered it was a source of illegally imported contact lenses and other health products. Over 114,000 items worth more than 11 million baht were seized. This operation highlights the Thai FDA's ongoing efforts to protect consumers from unapproved health products and reinforce strict regulatory enforcement against illegal imports in Thailand.

• 2025-10-14 06:38:43

Join Qualtech's free webinar "Southeast Asia Medical Device Compliance Update Series 2025: Indonesia, Thailand & Vietnam" on October 28, 2025, to gain practical insights into 3 of ASEAN's fastest-growing medical device markets. Learn about key regulatory updates, compliance strategies, and market opportunities directly from Qualtech's local regulatory experts. Stay informed, compliant, and ready for growth in Southeast Asia.

• 2025-08-25 05:57:23

Thai FDA has announced a significant update to the renewal process for Class 2, 3, 4 medical device certificates, effective from 22 July 2025. This reform introduces streamlined procedures, with automatic renewals for full CSDT dossiers and differentiated requirements for Partial pathway registrations. By reducing unnecessary document submissions, the Thai FDA aims to balance regulatory efficiency with patient safety.

• 2025-08-25 05:37:56

Thai FDA has recently introduced an optimized process for certain medical device advertisements, allowing specific categories of promotional content to be automatically approved. The framework accelerates market communication while maintaining compliance.

• 2025-06-03 06:29:29

Thailand's medical tourism industry offers a unique blend of affordable, high-quality healthcare and a captivating tourist experience. Patients worldwide are attracted by the diverse range of medical specialties, advanced technology, and international accreditation of Thai medical facilities. The country's growing demand for medical devices and supportive government policies further solidify its position as a leading medical tourism destination.

• 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.

• 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.