In 2015, Thailand along with other ASEAN members ratified the ASEAN Medical Device Directive (“AMDD”) in order to align regional regulations governing medical devices. To comply with the terms of the AMDD, Thailand has passed several amendments, regulations and notifications on the classification and registration requirements for medical devices. Importation and manufacture of medical devices has more recently increased due to the COVID-19 global pandemic. With an increasing interest in the life and health sciences sector, and a global need for medical devices and equipment, an understanding of Thailand’s regulatory regime related to medical devices is important for business operators including importers and manufacturers, in Thailand.