The Thai Food and Drug Administration (FDA) has reissued Guidelines for Determining Health-Type Software Products to help medical device registrants obtain accurate classification information. These guidelines provide clarity on which software products qualify as medical devices under Thai law, aiding stakeholders such as manufacturers, importers, and public health agencies in regulatory compliance.
Types of Health-Type Software Products
Software products are categorized into two main types:
- Embedded Software: Software built or installed with hardware for control or management.
- Standalone Software: Independent software, including:
- Web-based Applications: Operates through web browsers without installation.
- Applications: Requires installation on devices like mobile phones, computers, or smartwatches.
Users of these software products can range from individual home users to professional healthcare providers.
Classification Guidelines for Health-Type Software Products
The following guidelines outline the risk classification and intended use of various health-type software products:
- Vital Signs Monitoring: Includes software for blood pressure, heart rate, respiratory rate, oxygen saturation, and body temperature, with specific classification rules based on their intended use (e.g., sports versus medical diagnosis).
- Sleep Monitoring: Differentiates between general sleep tracking and specific applications like sleep apnea detection, which may be classified as medical devices.
- Mental Health Assessment: Covers software for mental health screening, stress testing, and mood monitoring.
- Disease Detection and Monitoring: Includes applications for monitoring chronic conditions, such as diabetes and cardiovascular health.
- Perception and Risk Assessment: Involves tools for assessing visual and auditory impairment and risk of future disease occurrences.
- Telemedicine: Defined as systems that enable remote healthcare delivery, including digital consultations and monitoring by licensed professionals.
- Medical Software: Applies to systems used in healthcare facilities for tasks such as electronic health records, patient management, and medical imaging.
Key Provisions of the Medical Device Act B.E. 2551 (Amended)
The guidelines align with Section 4 of the Medical Device Act B.E. 2551, as amended by Act No. 2 B.E. 2562, which specifies the classification criteria for medical devices and the regulatory requirements for each product type.
Detailed Product Classification
Each product type is classified based on risk level and intended use. Notable examples include:
- Classified Medical Devices: Software used for medical diagnostics, such as electrocardiograms (ECG), diabetic retinopathy screening, and cardiac treatment support, must follow stringent compliance protocols.
- Non-Medical Devices: Includes software for general wellness monitoring, such as fitness apps and general sleep monitoring tools.
Detailed Product Classification Table
For a detailed breakdown of each product type, classification, and risk
level, please refer to the table in the section below.
| Product | Type of product | Risk Classification | Remark | |||
|---|---|---|---|---|---|---|
| Non-Medical Device | Medical Device | Rule | Class | |||
| 1 | Vital signs | |||||
| 1.1 | Blood pressure | ✔ | 10 (1) | 2 | ||
| 1.2 | Body temperature | ✔ | 10 (1) | 2 | For medical diagnosis | |
| Body temperature | ✔ | To be used for checking through entry and exit doors, used in security systems | ||||
| 1.3 | Heart rate, Pulse rate | |||||
| 1.3.1 | To view your heart rate during exercise | ✔ | Athlete performance test/Common people use it for exercise | |||
| 1.3.2 | Exercise Stress test | ✔ | For medical purposes | |||
| 1.3.3 | Electrocardiogram: EKG or ECG | ✔ | 10 (1) | 2 | To check the sinus rhythm ECG or atrial fibrillation (AFib) in a recognizable form with an electrocardiogram pattern | |
| 1.3.4 | IRNF (Irregular Rhythm Notification Feature) | ✔ | 10 (1) | 2 | To analyze heart rate data to indicate the number of times Irregular heart rhythm which is a sign of Atrial Fibrillation (AFib) | |
| 1.4 | Respiratory rate, Oxygen saturation/SpO2/Pulse Ox | |||||
| 1.4.1 | Used for sports/climbing/travel | ✔ | ||||
| 1.4.2 | Hypoxemia | ✔ | 10 (1) | 3 | ||
| 1.5 | The maximum volume of oxygen (VO2 max) | |||||
| 1.5.1 | Examine the health of the heart, blood vessels, lungs, and muscles by exercising to know the performance level of the Athlete’s Physique/Fitness | ✔ | ||||
| 1.5.2 | Diagnosed cardiovascular and pulmonary diseases through Measurement, analysis, and interpretation of the oxygen metabolism rate of the body during exercise | ✔ | 10 (1) | 2 | ||
| 1.6 | Blood glucose | ✔ | 10 (1) | 2 | ||
| 1.7 | Measure body fat, Bioimpedance, fat mass | ✔ | ||||
| 2. | Sleep | |||||
| 2.1 | Deep sleep | ✔ | ||||
| 2.2 | Sleep Apnea | ✔ | 10 (1) | 3 | ||
| 2.3 | Sleep behavior | ✔ | ||||
| 3. | Mental health | |||||
| 3.1 | Stress test/screening for people who are stressed | ✔ | ||||
| 3.2 | Depression test to screen | ✔ | ||||
| 3.3 | Those at risk of suicide | ✔ | Statistical calculations from questionnaires, Use statistical calculations | |||
| 3.4 | Assessment of mental strength/mental health (RQ) | ✔ | ||||
| 3.5 | Practice meditation/breathing exercises/breath control/ balancing emotions | ✔ | To control stress levels | |||
| 3.6 | Happiness level measurement | ✔ | ||||
| 3.7 | Emotional intelligence assessment or application (Emotional Quotient: EQ) / happiness level assessment Mood (good mood/irritated) | ✔ | ||||
| 3.8 | Dementia level | ✔ | 10 (1) | 3 | Disease analysis/monitoring | |
| 4. | Fall detection | |||||
| 4.1 | Fall by walking | ✔ | In hospital/home | |||
| 4.2 | Fall out of bed | ✔ | In hospital/home | |||
| 5. | Perception | |||||
| 5.1 | Visual impairment | |||||
| Fundus Photography or Fundus Camera | ✔ | 10 (1) | 2 | |||
| Myopia, astigmatism, and long-sightedness | ✔ | 12 | 1 | |||
| 5.2 | Hearing impairment | ✔ | 10 (1) | 2 | ||
| 5.3 | Learning disorder (LD)/Learning disability | ✔ | 10 (1) | 2 | ||
| 6. | Risk assessment | |||||
| 6.1 | Risk of any disease in the future/Prediction of future disease occurrence | ✔ | Response to the Evaluation Questionnaire Respondent | |||
| 6.2 | High-risk area test | ✔ | ||||
| 7. | Planning | |||||
| 7.1 | Planning treatment for the disease | ✔ | 10 (1) | 2 | Such as planning dental braces by program Analysis of tooth movement | |
| 7.2 | Diet/Exercise planning | ✔ | ||||
| 8. | Alarm/Notification | |||||
| 8.1 | Take medicine/walk/exercise. | ✔ | ||||
| 9. | Service | |||||
| 9.1 | Provide advice on medicines/order medicines | ✔ | ||||
| 9.2 | Cabinets or robots for drug dispensing/drug organizing/drug delivery/drug production/therapy chemical drug mixing | ✔ | ||||
| 9.3 | Cabinets or vehicles for service of temperature measurement /Blood pressure/chest x-ray examination/Service for collecting equipment of specimens from the body (only cabinet) | ✔ | Thermometers/ Blood pressure /X-ray machines/collecting equipment of specimens from the body are classified as medical devices | |||
| 9.4 | Telemedicine refers to the provision of medical and public health services by a healthcare facility to individuals seeking care, delivered by licensed medical professionals through remote medical services. It involves the exchange of information that is beneficial for consultation, examination, diagnosis, treatment, nursing, disease prevention, health promotion, and physical rehabilitation. Additionally, it serves as a valuable tool for the continuing education of medical and public health personnel. | ✔ | Related Announcements
| |||
| 9.5 | Telemedicine System refers to a system that utilizes digital technology to provide medical and public health services remotely by transmitting visual and audio data or through other methods. | ✔ | Related Announcements
| |||
| 9.6 | Medical Software | ✔ | Used in various healthcare facilities such as health centers, clinics, and hospitals, this system helps make the work of doctors and healthcare facilities more convenient and efficient. It includes systems for internal organizational management, electronic health record services, patient appointment scheduling, patient data storage, and payment processing systems. | |||
| 10 | Medical software | |||||
| 10.1 | Software used for storing and transmitting medical images or data specifically for patients. | ✔ | 12 | 1 | ||
| 10.2 | Software used for screening for diabetic retinopathy | ✔ | 10 (1) | 2 | ||
| 10.3 | Medical imaging diagnostic software for stroke/cardiac disease treatment | ✔ | 10 (1) | 3 | ||
| 10.4 | Software is used to monitor the operation of the defibrillator. | ✔ | 9 (2) | 3 | ||
| 10.5 | Software for monitoring important body parameters during coronary angioplasty. | ✔ | 10 (1) | 3 | ||
| 11 | A computer program (chatbot) is developed to play a role in automatically responding to text-based conversations through messaging applications. It functions as an automated response program. | ✔ | ||||
Detailed Product Classification Table
For a comprehensive understanding of these guidelines, please refer to the full document 10.-สรุปข้อมูลวินิจฉัยผลิตภัณฑ์-software-ข้อมูล-ณ-วันที่-9-พ.ย.-65 (in Thai).
Contact Information
For further information or inquiries, please contact us at sales@andamanmed.com or click the button below for assistance with compliance and registration.