Thailand: FDA Guidelines for Software as Medical Device (SAMD)

ARQon
Feb 22, 2023
1 min read

Thailand Food and Drug Administration (FDA) published guidelines to determine the state and risk categorization of medical device software in Thailand on 10 November 2022. The guidelines covered on both standalone software and embedded software. This advice is probably in response to questions that have been asked in the 16 months since the new medical device rules went into effect.

FDA Consultation in Thailand

Device manufacturers that wish to acquire a formal determination from Thai FDA may choose to file a justification application for products that are not included in the advice. Justification process takes about a month and cost about US$26 each. The Thai FDA may query on the application, so manufacturers should respond in a short time. Otherwise, the application might get rejected and manufacturers must have to submit a new application. Manufacturers should attach documents listed below for the justification application:

Justification document
IFU
Product images
Materials
Classification in other countries
HS Code

Thailand Examples of Software Used as a Medical Device

The guideline published 11 product types that can be deemed as medical or non-medical devices which are vital sign monitoring, sleeping, mental health, fall detection, risk assessment, ability deficiency, planning, alarm system, services, medical software and chatbots. The table below shows examples of the classification. Full detail for software classification can refer here.