The Thai FDA has compiled and categorized groups of active medical devices based on similar principles of operation and intended use to identify applicable standards for each group. These standards are provided for advisory references only to assist registrants in preparing relevant test reports for submission under the ASEAN Common Submission Template Dossier (CSDT).
Core Requirements for All Active Medical Devices
Active medical devices registered in Thailand are generally expected to align with:
- IEC 60601-1 (General safety and essential performance)
- IEC 60601-1-2 (Electromagnetic compatibility)
- IEC 60601-1-6 OR IEC 62366-1 (Usability)
Device-Specific Standards
- IEC 60601-2-X series: Particular standards for each device type
- IEC 60601-1-11: Applicable for home/lay user devices outside clinical settings
- IEC 60601-1-3: Applicable for diagnostic X-ray equipment
Biocompatibility Testing
Device components with patient contact or invasive use require:
- ISO 10993-1 (Biological evaluation)
- Additional applicable ISO 10993 series standards based on risk assessment per ISO 10993-1
Software Requirements
Active devices with embedded software must follow:
- IEC 62304 (Medical device software lifecycle)
| Device Type | Intended Use | General Reference Standards for Active Medical Devices | Device-Specific Reference Standards (If applicable) |
| Digital Blood Pressure Monitor | Measure systolic and diastolic blood pressure for medical diagnosis | IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6 or IEC 62366-1 | IEC 60601-1-11, IEC 80601-2-30 |
| Suction Device | Removes bodily fluids and secretions from patients | ISO 10079-1 | |
| Automated External Defibrillator: AED | Restores normal heart rhythm during cardiac fibrillation | IEC 60601-1-11, IEC 60601-2-4, ISO 10993-1 | |
| Electrocardiography (ECG) | Records heart's electrical signals for cardiac diagnosis | IEC 60601-2-25, ISO 10993-1 | |
| Pulse Oximeter | Measures blood oxygen saturation (SpO2) | IEC 60601-1-11, ISO 80601-2-61, ISO 10993-1 | |
| Infrared Thermometer | Non-contact body temperature measurement | IEC 60601-1-11, ISO 80601-2-56, ISO 10993-1 | |
| Nebulizer | Delivers liquid medication to respiratory system and lungs | IEC 60601-1-11, ISO 27427, ISO 10993-1 | |
| Hearing Aid | Enhances hearing for individuals with hearing loss | IEC 60601-1-11, IEC 60601-2-66, ISO 10993-1 | |
| Dental Unit (including Handpieces, Motor) | Positions patients for dental procedures | IEC 80601-2-60, ISO 14457, ISO 7494-1 | |
| Endoscope (GI) | Diagnostic visualization and surgical procedures in digestive tract | IEC 60601-2-18, ISO 8600, ISO 10993-1 | |
| Diagnostic Ultrasound | Diagnostic imaging of internal organs using high-frequency sound waves | IEC 60601-2-37, ISO 10993-1 | |
| Electronic nerve stimulator | Relieves acute and chronic pain through electrical nerve stimulation | IEC 60601-2-10, ISO 10993-1 | |
| Infusion pump /Syring pump | Precisely controls IV delivery of fluids, nutrients, and medications | IEC 60601-2-24 | |
| X-Ray Diagnostics | Diagnoses abnormalities in lungs, heart, bones, chest, and internal organs | IEC 60601-1-3, IEC 60601-2-28, IEC 60601-2-54 | |
| Electroencephalography (EEG) | Records brain electrical activity to locate neurological abnormalities | IEC 60601-2-26 | |
| Infant phototherapy | Light therapy treats neonatal jaundice from elevated bilirubin levels | IEC 60601-2-50 | |
| Dental X-Ray | Diagnoses dental conditions affecting teeth, roots, jaw, and facial bones | IEC 60601-1-3, IEC 60601-2-63, IEC 60601-2-65 | |
| Magnetic Resonance Imaging | Advanced diagnostic imaging for disease detection and treatment planning | IEC 60601-2-33 | |
| Tonometer | Measures intraocular pressure for glaucoma risk assessment and monitoring | ISO 8612, ISO 15004-1, ISO 10993-1 | |
| Electric breast pump | Assists lactating mothers in expressing and storing breast milk | IEC 60601-1-11, ISO 10993-1, Other standards demonstrating food grade materials (for equipment supporting or contacting breast milk; must be food-grade and BPA-free). | |
| Feeding pump | Delivers liquid nutrition to patients unable to swallow or eat adequately | NA | |
| Nasal aspirator | Removes mucus and nasal secretions | IEC 60601-1-11, ISO 10993-1 | |
| Fundus camera | Photographs retina for diagnosing and monitoring eye conditions (No include Artificial Intelligent (AI)) | ISO 15004-1, ISO 10940 | |
| Oxygen concentrator | Provides supplemental oxygen for respiratory patients | IEC 60601-1-11, ISO 80601-2-69, ISO 10993-1 | |
| Medical supply unit (E.g.: Bed head unit, Medical pendant) | Delivers electrical power, communications, data, lighting, medical gases, and vacuum systems to healthcare areas | ISO 11197 | |
| Robotic Orthosis, Exoskeleton | Assists mobility-impaired patients with neuromuscular or skeletal conditions; controls arm and leg movement | IEC 80601-2-78, IEC 62304 | |
| Digital image plate (for general X-ray images) | Converts X-ray energy into digital images viewable on computer screens | IEC 62304 | |
| HIFU (High intensity focused ultrasound) | Non-invasive facial lifting, wrinkle reduction, and skin tightening | IEC 60601-2-62, ISO 10993-1 | |
| CT Scan (Computerized Tomography) | Cross-sectional imaging for diagnosing internal organ abnormalities | IEC 60601-1-3, IEC 60601-2-44, ISO 10993-1 | |
| CPAP/ BIPAP/Auto CPAP | Positive airway pressure therapy for sleep apnea treatment | IEC 60601-1-11, ISO 80601-2-70, ISO 80601-2-74 | |
| Patient Monitor | Continuous vital signs monitoring including heart rate, blood pressure, ECG, SpO2, and temperature | IEC 60601-1-8, IEC 60601-1-12, IEC 80601-2-49, (If contains ECG) IEC 60601-2-27, (If contains blood pressure monitoring function) IEC 60601-2-30, IEC 60601-2-34, (If contains respiratory gas monitoring function) ISO 80601-2-55, (If contains temperature measurement) ISO 80601-2-56, (If contains pulse oximeter function) ISO 80601-2-61, (If contains software) IEC 62304 |
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Reference:
Recommendations on Required Test Reports for the Registration of Active Medical Devices