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Thailand FDA Publishes Guidance for Software as Medical Device (SaMD)
Published on: December 15th, 2022
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.
Examples of Software as a Medical Device in Thailand
The guidance covers 11 common product types and provides examples of Software as a Medical Device that are (or are not), considered medical devices. The product types covered include vital signs monitoring, sleep monitoring, mental health evaluation, fall detection, perceptual impairment, risk assessments, planning, alarm/notifications, service/operations, medical software, and chatbots.
Examples of SaMD:
- Body temperature (diagnostic)
- Exercise Stress test (EST)
- Electrocardiogram : EKG or ECG
- Hyperxemis assessment
- Sleep apnea
- Software for storage and transfer of patient medical data
- Software for Diabetic Retinopathy screening
- Software for medical diagnostics on stroke/heart disease treament
- Software for monitoring defribrilators
- Software for monitoring the important parameters of the patient during cardio surgery
Examples of products not considered SaMD:
- Body temperature (safety purposes)
- Performance of heart, blood vessel, lung and muscle by exercise test
- Measurement of body fat, body fluid (Bioimpedance)
- Disease risk prediction
- Alarm for daily activities
- Remote medicine service system
- Medical operations software
- Mental health assessments
Note: Depending on the intended use, treatment plans could be either, a medical device or not.
Please click here for the guidance in Thai and here for an English translation.
For more information on the registration process in Thailand, please see our Thailand Medical Device Registration page.
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Asia Actual has an office in Singapore and Bangkok staffed by experienced, bilingual regulatory and commercial professionals to address any questions or provide support. Please contact us to explore if this new program is appropriate for your devices.
Asia Actual is a regulatory consulting company specializing in helping manufacturers grow their sales through independent license holding, direct fulfillment, and a variety of sales channel support services.