DOOSIGAN / Thailand regulatory updates
We review recent notices from Thai regulators and explain their practical impact by product category.
01 / Regulatory updates
3 regulatory updates
Thai FDA has added Malaysia's Medical Device Authority (MDA) as the eighth foreign authority whose device assessments it accepts. Only devices approved under the MDA–Thai FDA regulatory reliance programme qualify, effective 6 October 2026.
Thai FDA has issued the 23rd addition to its list of experts and organisations that evaluate medical device technical documentation. Alongside three individual experts, the Electrical and Electronic Products Testing Center (PTEC) under NSTDA has been added.
The Thai FDA Medical Device Control Division announced that its new system for medical-device clinical trial applications would open on 9 September 2026. Teams preparing new applications should check account access and the revised submission workflow.
