Thailand’s FDA has issued a new notification, effective July 16, 2026, that changes the documentation required to renew a drug registration certificate. Renewal is no longer a routine administrative step, as applicants must now demonstrate that their quality, efficacy, and safety documentation... Read More
Thailand is raising the bar for medical device software. A revised labeling regulation taking effect June 20, 2026, brings stricter documentation standards and, notably, the country’s first-ever unique device identification (UDI) requirement for software as a medical device (SaMD). The rule covers moderate... Read More
Thailand’s Food and Drug Administration finalized its Medical Device Labeling Regulation (B.E. 2568) on December 22, 2025. The regulation consolidates prior fragmented rules into a single framework. Mandatory compliance needs to start by June 20, 2026. The new rules clarify labeling content,... Read More
Malaysia’s Medical Device Authority (MDA) and Thailand’s Food and Drug Administration (Thai FDA) have recently signed a Confidentiality Agreement and launched a three-month regulatory reliance pilot to accelerate medical device approvals and reduce duplicate reviews in each country. Announced in early December 2025,... Read More
According to the recent Medical Facility Act in Thailand, telemedicine is now allowed and becoming more pervasive. Hospitals and clinics can diagnose, prescribe, and send out electronic prescriptions after a video call with a doctor is completed. Also, telepharmacy now permits a... Read More
The Thai FDA announced updated renewal procedures for Class 2, 3, and 4 medical devices, which came into effect on July 22, 2025. Renewal applications must be submitted on an annual basis, between October 1 and December 31. Devices that were originally... Read More
On 1 May 2025, Thailand’s Food and Drug Administration (TFDA) launched its new e-Certificate system. Certifications of all health products in Thailand are now online. The system aims to reduce some of the bureaucratic hurdles for manufacturers, importers, and distributors, with quicker,... Read More
Introduction Quality, safety, and efficacy are of the utmost importance for drug products. A vital part in achieving this is having a Drug Master File (DMF). A DMF is a confidential submission to a health authority to provide detailed information about the... Read More
In January, the Thai Food and Drug Administration (Thai FDA) released updated Change Notification Guidelines for In Vitro Diagnostic (IVD) products. The new guidelines took effect on January 15, 2025. To add medical device items, manufacturers must submit change requests that must be... Read More
Recently, The Asia Pacific Medical Technology Association (APACMed) released their position paper titled “Risk-based Change Management for Registered Medical Devices.” As noted in this paper, some Asian countries utilize risk-based methods for device changes, while others require change submissions no matter what... Read More