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
In May, the Thai Food and Drug Administration (TFDA) released new registration guidelines on Software as a Medical Device (SaMD) in Thailand. These guidelines are designed to establish regulations for software-based medical innovations and clarify pathways to reduce uncertainty and expedite market... Read More
Importers who purchase and bring into Thailand foreign drugs need to get those imported drugs registered in Thailand before they can be sold. One of the requirements for Thai drug registration is foreign drug facilities must meet GMP standards. Recently, the Thai... Read More
The Thai Food and Drug Administration (FDA) has recently updated its regulatory framework, introducing changes designed to streamline the process for device registration in Thailand. These changes, which take effect immediately following their publication in the Royal Gazette, are aimed at simplifying... Read More
The Thai Food and Drug Administration (FDA) has announced new regulatory frameworks designed to elevate the quality of medical devices in Thailand. As part of this initiative, two important notifications have been issued: the Good Manufacturing Practice (GMP) and the Good Importing... Read More
In recent years, Thailand, a Southeast Asian country with 70 million people, has been consistent in its commitment to improving the regulation of pharmaceuticals, ensuring the safety, efficacy, and accessibility of drugs in the market. Two significant developments include the initiation of... Read More
Starting February 14, 2024, the Thai FDA has enhanced its medical device registration requirements. Prior to this new regulation, medical devices generally only required a partial ASEAN Common Submission Dossier Template (CSDT), but now a full CSDT is required. The Thai FDA... Read More
On March 1, 2024, new regulations governing drugs imported into Thailand for clinical studies will come into effect, transforming Thailand’s clinical trial landscape. These regulations introduce a detailed framework for the importation of drugs for clinical studies. Notably, while there were no... Read More