ABSTRACT
The total medical device market size in Thailand was estimated around US$1,259 million in 2016 with an expected growth rate of 10% in 2017. The medical device market in the Association of Southeast Asian Nations (ASEAN) countries was about $4.6 billion in 2013. ASEAN is implementing a plan to harmonize medical device regulations called the ASEAN Medical Device Directive (AMDD). The AMDD lays out basic requirements for medical device safety and performance, the medical device classification system, a Common Submission Dossier Template for medical devices (CSDT), and an ASEAN-wide post marketing alert system. Thailand is a liberal market without any restrictions on the importation and sale of medical devices, except for the registration of the products with the Thai Food and Drug Administration (FDA). As Thailand has signed ASEAN Agreement on Medical Device Directive (AMDD) on 21 November 2014, it plans to make ratification to the Secretary-General of ASEAN by the end of 2017.
