On November 22, 2024, the Thai FDA published an infographic on its official website, providing clarity on the classification of vehicles and medical equipment as medical devices under Thailand’s Medical Device Acts.
Vehicles: Not Classified as Medical Devices
The infographic specifies that the following vehicles are not considered medical devices under Section 4 of the Medical Device Acts (B.E. 2551):
- Ambulance
- Emergency vehicle
- Mobile medical check-up vehicle
- Mobile X-ray vehicle
- Mobile dental vehicle
- Mobile laboratory vehicle
Medical Equipment in Ambulances or Specialized Medical Vehicles
The infographic also highlights that certain medical equipment used within ambulances or vehicles for medical purposes is classified as medical devices. This classification is based on the definitions in Section 4 of the Medical Device Acts (B.E. 2551) and the amended Medical Device Act (B.E. 2562). Examples include:
- Blood Pressure Monitor / Electrocardiogram (ECG) Machine
- Intended Use: Diagnosis and monitoring of diseases and injuries in humans.
- Classification: Medical device under Section 4 (1)(ก).
- First Aid Kits (e.g., cotton wool, wound dressings)
- Intended Use: Alleviating or treating injuries in humans.
- Classification: Medical device under Section 4 (1)(ข).
- Head Immobilizer / Hard Collar
- Intended Use: Supporting or sustaining life.
- Classification: Medical device under Section 4 (1)(ค).
Further Information
For detailed information, you can access the infographic and official clarification document on the Thai FDA’s website via the following link:
Thai FDA Medical Device Clarification.
For inquiries regarding this announcement, please reach out to our team at sales@andamanmed.com or click the button below to contact us.
