Category Archives: Medical Devices

Medical Devices Regulatory: List of Accepted Foreign Agencies

Medical Devices Regulatory

Medical Devices Regulatory: List of Accepted Foreign Agencies for Inspection or Certification of Medical Devices The Food and Drug Administration has provided a list of foreign agencies accepted for inspection or certification of medical devices or medical device establishments in 2024. This list, announced on June 4, 2024, outlines the agencies and their scope of… [read more]

Thai FDA Concise Program for Medical Device Registration

Thai FDA Concise Program

Concise evaluation and Reliance program 2024 is the notification ruling the Thai FDA Concise Program for Medical Device Registration. In the dynamic landscape of healthcare, ensuring the safety and efficacy of medical devices is paramount. Thailand, with its burgeoning healthcare sector, has implemented robust regulatory frameworks to oversee the registration of medical devices. Among these… [read more]

Warehouse for Thai FDA license

Warehouse for Thai FDA license

Warehouse for Thai FDA license: unlock Your Path to Thai FDA Licensing with Siam Building’s Specialized Warehouse Units Welcome to Siam Building, the premier destination for businesses seeking top-tier warehouse facilities tailored explicitly for Thai FDA licensing requirements. Strategically located in Pathum Thani, Thailand, our cutting-edge warehouse units are owned and operated by Siam Trade… [read more]

Possible changes in Thai FDA Medical Device License

Possible changes in Thai FDA Medical Device License

Can I request any change in Thai FDA Medical Device License after it has been released? Medical device regulation in Thailand is overseen by the Thai Food and Drug Administration (FDA), which ensures the safety, quality, and efficacy of medical devices circulating within the country. Obtaining a medical device license in Thailand is a crucial… [read more]

MEDICAL DEVICES RISK CLASSIFICATION THAI FDA

MEDICAL DEVICES RISK CLASSIFICATION in Thailand

MEDICAL DEVICES RISK CLASSIFICATION IN THAI FDA What is the classification of my medical device in Thailand? here’s the answer   Medical Devices risk classification are clearly stated in the official documentation issued in 2021, following the new regulations issued in 2021. Since then, we receive from new customers always the same question: what is… [read more]