In conformity with the “Ministry of Public Health regarding Medical device categories shall be registered under notified medical device B.E.2563 (2020)“, therapeutic medical devices are classified under Listing (Class1 medical device).
Starting from 3rd December 2022, Thai FDA agreed to implement the new risk classification from Notified Medical Device (Class 2 or 3) to Listing Medical Device (Class 1) in accordance with the latest updated “Ministry of Public Health regarding Medical Device Categories in which shall be registered as notified medical device (3rd Edition) B.E.2565 (2022)”
In summary, therapeutic medical devices (class 1) that are compulsory to be registered under the Class 1 route are the following:
Therapeutic Medical Devices |
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1. Superficial heat |
1.1 Powered heating pad or electric heating pad |
1.2 Steam bath cabinet |
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1.3 Moist air heat therapy unit |
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2. Controller cold compression unit (Only the electric device) |
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3. Hydrotherapy or immersion hydrobath |
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4. Direct current device or equipment |
4.1 Galvanic or direct current |
4.2 Interrupted direct current |
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5. Electric current frequency lower than 2,000 Hz |
5.1 Sinusoidal current |
5.2 Diadynamic current |
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5.3 Faradic current |
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5.4 High voltage current |
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5.5 Transcutaneous electrical nerve stimulation - TENS |
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6. Electric current frequency 2,000 – 6,000 Hz |
6.1 Interferential current |
6.2 Russian current |
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7. Electric current frequency more than 6,000 Hz |
7.1 Shortwave diathermy |
7.2 Microwave diathermy |
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8. Static current |
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9. Magnetotherapy |
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10. Non-ionized radiation therapy |
10.1 Ultraviolet |
10.2 Infrared |
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10.3 Low power laser |
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11. Mechanotherapy |
11.1 Massager *In case intended use/indication are as follows. a. Temporarily relaxes the specific muscles b. Temporarily increase local blood circulation c. To prevent pressure ulcers |
11.2 Vibrator *In case intended use/indication are as follows. a. Temporarily relaxes the specific muscles b. Temporarily increase local blood circulation c. To prevent pressure ulcers |
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11.3 Pressure-applying device |
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11.4 Electric traction machine |
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11.5 Ultrasound |
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12. Exercise therapy |
References:
Medical device categories shall be registered under notified medical device B.E.2563 (2020)
Risk Classification of medical devices B.E. 2562 (2019)
Guideline on medical device labelling and device document preparation B.E.2563 (2020)