Regulatory Strategy for Medical Devices and Pharmaceuticals/Drugs in Thailand

Thailand is a large country in South East Asia with about 64 million people.

In Thailand, both drugs and medical devices are regulated by the Thai Food and Drug Administration (FDA) and require registration before marketing. The Thai FDA is also responsible for post-marketing control. They may inspect samples of products and check for compliance and quality. Previously-approved products are also revisted periodically to ensure consistency of manufacturing and product standards over time.

You cannot register a drug or device in Thailand without either a local Thai office or a local distributor. Therefore, if you do not plan to open your own local office, it is important to select a distributor with good regulatory capabilities.

For more information on regulatory issues in Thailand, please see the following PBM publications and/or contact us to discuss your specific needs.