Thailand FDA Publishes Guidance for Software as Medical Device (SaMD)

On November 10th, the Thai FDA published guidance to assist with the determination of medical device status and risk classification for medical device software in Thailand. Software as a Medical Device, also known as SaMD includes standalone software and embedded software. This guidance is likely in response to inquiries received over the last 16 months since the new medical device Rules were implemented. 

Original guidance on the classification and justification of Software as a Medical Device (SaMD) can be found here in Thai, while an English translation can be found here. 

Please contact us if you’d like to better understand your regulatory requirements for Software as a Medical Device in Thailand or other markets in Asia. 

Thai FDA Consultation Option 

Manufacturers of devices not listed in the guidance, can choose to submit a Justification application to receive a formal determination from the Thai FDA. As part of the application, manufacturers will need to submit the following documents: Justification document, IFU, pictures of the product, materials, classification in other countries, HS Code and more. 

Justification applications take about a month and come with a fee of about US$26 each. It is also important to note that manufacturers will only be given a short period of time to answer any queries the Thai FDA may have. If not answered in time, the application could be rejected and a new application would be required. 

The Thai FDA is also willing to provide informal feedback in person or over the phone.