Thai FDA defines “Software” as the instruction sets or programs used to command a computer to work. The software can be divided into 2 types as follows.
● 1. Embedded Software (Software that is embedded or installed with hardware to control or manage the operation.)
● 2. Standalone Software (Software that can be used alone without connecting to a computer.)
- Web-based application: Software that runs through web browsers such as Google Chrome, Firefox, Microsoft Edge without installation.
- Application: A program that requires installation on electronic devices such as mobile phones, computers, smart watches etc.
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No. |
Product |
Product type |
Risk Classification |
Remark |
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|
Non-Medical Device |
Medical Device |
Rule |
Class |
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|
1 |
Vital signs |
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|
1.1 |
Blood pressure |
|
• |
10 (1) |
2 |
|
|
1.2 |
Body temperature |
|
• |
10 (1) |
2 |
For medical diagnosis |
|
|
Body temperature |
• |
|
|
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For entrance door, safety purpose |
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1.3 |
Heart rate, Pulse rate |
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|
(1) |
For monitoring heart rate during exercise |
• |
|
|
|
Athlete / ordinary people may use it during exercise |
|
(2) |
EST (Exercise Stress test) |
|
• |
10 (1) |
2 |
For medical purpose |
|
(3) |
Electrocardiogram: EKG or ECG |
|
• |
10 (1) |
2 |
ECG: Sinus, AFib |
|
(4) |
IRNF (Irregular Rhythm Notification Feature) |
|
• |
10 (1) |
2 |
Atrial Fibrillation (AFib)] |
|
1.4 |
Respiratory rate, Oxygen saturation/SpO2/Pulse Ox |
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|
(1) |
For sport activities or travelling |
• |
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|
(2) |
Hypoxemia assessment |
|
• |
10 (1) |
3 |
|
|
1.5 |
The maximum volume of oxygen (VO2 max) |
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|
(1) |
Performance of heart, blood vessel, lung and muscle by exercise test |
• |
|
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|
|
|
(2) |
Diagnose heart disease and artery and lung disease by measure, analyze and interpret the O2 metabolism rate during exercise |
|
• |
10 (1) |
2 |
|
|
1.6 |
Blood glucose |
|
• |
10 (1) |
2 |
|
|
1.7 |
Body fat, body fluid (Bioimpedance), fat mass measurement |
|
• |
|
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|
2 |
Sleeping |
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|
2.1 |
Deep sleep |
• |
|
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|
2.2 |
Sleep Apnea |
|
• |
10 (1) |
3 |
|
|
2.3 |
Sleep behavior analysis |
• |
|
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|
3 |
Mental Health |
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|
3.1 |
Stress test / screening |
• |
|
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3.2 |
Depression test |
• |
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3.3 |
Suicidal risk screening |
• |
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Statistical calculations from questionnaires using statistical calculations |
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3.4 |
Resilience Quotient (RQ) |
• |
|
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3.5 |
Meditation practice / Breathing practice / Breath setting / Emotional balance |
• |
|
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For stress management |
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3.6 |
Happiness measurement |
• |
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3.7 |
Emotional Quotient assessment, application / emotional level assessment (good mood/irritability) |
• |
|
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3.8 |
Dementia assessment |
|
• |
10 (1) |
3 |
For analysis / monitoring |
|
4 |
Fall detection |
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|
4.1 |
Fall detection (walking) |
• |
|
|
|
For hospital / home use |
|
4.2 |
Fall detection (sleeping) |
• |
|
|
|
For hospital/ home use |
|
5 |
Perceptual defect |
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|
5.1 |
Visual impairment screening |
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|
Fundus Photography or Fundus Camera |
|
• |
10 (1) |
2 |
|
|
|
Vision measurement device |
|
• |
12 |
1 |
|
|
|
5.2 |
Hearing impairment screening |
|
• |
10 (1) |
2 |
|
|
5.3 |
Learning disorder (LD) / Learning disability |
|
• |
10 (1) |
2 |
|
|
6 |
Risk assessment |
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|
6.1 |
Risk of getting any disease in the future / prognosis of future disease |
• |
|
|
|
Questionnaires |
|
6.2 |
Risk area of contracting the disease assessment |
• |
|
|
|
|
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7 |
Planning |
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|
7.1 |
Treatment plan |
|
• |
10 (1) |
2 |
For example, planning orthodontic treatment by analyzing the movement of teeth |
|
7.2 |
Meal / Exercise plan |
• |
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8 |
Alarm/Notification |
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|
8.1 |
Reminder to take medicine / walk / exercise |
• |
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9 |
Service |
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|
9.1 |
Medicine recommendation |
• |
|
|
|
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|
9.2 |
Machine or robot dispensing / organizing / delivering / producing medicines / mixing chemotherapy drugs |
• |
|
|
|
|
|
9.3 |
Area or vehicle for medical services |
• |
|
|
|
Thermometer / blood pressure monitor /x-ray machine / specimens collection device are classified as a medical device. |
|
9.4 |
Telemedicine |
• |
|
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|
|
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9.5 |
Digital telemedicine service system |
• |
|
|
|
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9.6 |
Medical software |
• |
|
|
|
Used in a variety of medical facilities. This includes the organization's operational management system, electronic health record, patient appointment, patient information, payment system. |
|
10 |
Software |
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|
10.1 |
Software for storage and transfer of patient medical data |
|
• |
12 |
1 |
|
|
10.2 |
Diabetic retinopathy screening software |
|
• |
10 (1) |
2 |
|
|
10.3 |
Medical imaging diagnostic software for stroke / heart disease treatment |
|
• |
10 (1) |
3 |
|
|
10.4 |
Defibrillator Monitoring Software |
|
• |
9 (2) |
3 |
|
|
10.5 |
Software for monitoring the important parameters of the patient during cardio surgery |
|
• |
10 (1) |
3 |
|
|
11 |
Chatbot |
• |
|
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References:
Thai FDA: Guidance on Software as Medical Device (9 November 2022)