Thailand Medical Device
Thailand’s closer alignment with ASEAN Medical Device Directive brings about standardized medical device regulations focusing on patient safety.
Strategically located at the heart of Southeast Asia, Thailand is a leading destination for medical tourists both within the region and from all over the world. As of September 2021, Thailand has 62 JCI-accredited hospitals, the highest in Asia. For the 2020-2021 Medical Tourism Index, the Medical Tourism Association ranked Thailand fifth out of forty-six countries. In 2019, Thailand received over 3 million medical tourists creating revenue of over $700 million. In 2020, the value of Thailand’s medical device market was approximately $6 billion. U.S. medical devices are generally regarded as high quality in the Thai market and multiple medical construction projects are currently underway or being planned.
In February 2021, Thailand’s Food and Drug Administration issued new medical device regulations in compliance with the ASEAN Medical Device Directive (AMDD), with which the country has committed to fully comply by 2022.Thailand is a member of The Association of Southeast Asian Nations (ASEAN), consisting of ten countries (Brunei Darussalam, Cambodia, Indonesia, Lao PDR, Malaysia, Myanmar, Philippines, Singapore, Thailand and Vietnam), The AMDD is a harmonized medical device regulation applicable across ASEAN countries. Thailand has signed the ASEAN agreement on medical device directive accepting the AMDD. Singapore, Malaysia, and Indonesia have fully complied with the AMDD.
Thailand’s new regulations provide more standardization across the ASEAN region and are expected to enhance patient safety. U.S. exporters of medical devices may benefit from the changes in these registration procedures for medical devices in Thailand. As an example, the changes enable U.S. companies to access a period of license validity of up to five years once they receive a license in Thailand.
In Thailand, medical devices are classified into four categories based on risk and closely follow the ASEAN Medical Device Directive. Non-invasive medical devices are mostly regarded as Class 1 which requires less documentation. Conformity Assessments under the new regulations will require applications for Class 2-4 products be submitted in the Common Submission Dossier Template (CSDT) format.
Prior to the importation into Thailand, local importers or distributors need to register medical devices with the Thai FDA and submit information based on the Thai FDA’s manual of medical device classification. The process to register a medical device can take from 200 – 300 days to receive approval. U.S. companies’ partners, including their local importers and distributors, help with this process, which includes ensuring accurate classification of Class 1 or Class 2-4 devices upon registration. Once approved, registration licenses are valid for five years for Class 1, and four years for Classes 2-4. Registration fees and process timelines for each class varies.
The key to success in Thailand is to obtain a qualified local representative. If you are interested in expanding to Thailand and look for local partners, please contact the U.S. Commercial Service in Bangkok: email@example.com