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Thailand FDA Provides Guidance on Classification of Physical Therapy Devices
Published on: January 20th, 2023
Updated Requirements for Physical Therapy Devices
On December 3rd, 2022, the Thailand FDA (TFDA) issued new guidance on the classification of physical therapy devices. This has been done to address confusion created by the transition from product categorization under the old medical device rules, to risk classification under the new medical device rules. The guidance also specifically identifies electrical massagers and Class 1 medical devices.
If you are interested in learning more about the Thailand FDA or are looking to get market access for your product in Thailand, feel free to contact us here.
Under the old Rules, physical therapy devices were categorized as Notified Devices and subject to more scrutiny than most General Medical Devices by the TFDA. Under the new Rules, physical therapy devices are subject to the standard classification guidelines outlined in the Rules, most being Class 1 Listed, or Class 2 Notified medical devices. Significantly, physical therapy devices now qualify for the expedited Partial 2 regulatory review pathway and can avoid the time consuming Specialist Review process.
The new regulation specifically identifies massagers and vibrators and now classifies both products as a Class 1 Rule 12 medical device, due to the abilities listed below. Not all physical therapy devices can be registered as Class 1 Listing medical devices, only massagers and vibrators intended to be used in the ways listed below:
- The ability to relax specific muscles in the body
- The ability to increase local blood circulation
- The ability to prevent the creation of pressure ulcers
Necessary Documentation for Registering Physical Therapy Devices with the TFDA
Manufacturers/importers of devices with massaging/vibrating functions must submit a medical device registration application in accordance with the “Ministerial Regulations on Permission and Issuance of a License to Manufacture or Import Medical Devices.” More information on medical device registration in Thailand can be found on our website here. This application will be filed through the usage of the TFDA e-submission system, requiring these documents/evidence:
- Evidence/documentation of medical device labeling
- Instructions for use
- Product specifications
- Document showcasing the name/location of the manufacturing facility
- Declaration of conformity
- Letter of authorization (for importing)
- Document showcasing history of registration abroad (for foreign registered products)
- Grouping Indication Letter (if necessary)
Physical Therapy Devices Affected by the TFDA’s New Ruling
The following devices will be affected by the TFDA’s latest requirements for physical therapy devices:
- Surface heat therapy devices
- Electric/powered heating pads
- Steam bath cabinets
- Cold compression units
- Hydrotherapy/immersion hydro-baths
- Direct current therapy devices
- Galvanic therapy device
- Interrupted direct current therapy devices
- Devices that provide therapeutic effect with an electric current lower than 2,000 kHz
- Sinusoidal current therapy devices
- Diadynamic current therapy devices
- Faradic current therapy device s
- High voltage current therapy devices
- Transcutaneous electrical nerve stimulations – TENS
- Devices that provide therapeutic effect with an electric current between 2,000-6,0000 kHz
- Interferential current therapy devices
- Russian current therapy devices
- Devices that provide therapeutic effect with an electric current more than 6,0000 kHz
- Shortwave diathermy therapy devices
- Microwave diathermy therapy devices
- Static current therapy devices
- Magnetotherapy devices
- Non-ionized radiation therapy devices
- Ultraviolet therapy devices
- Infrared therapy devices
- Low-power laser therapy devices
- Mechanotherapy devices
- Pressure-applying devices
- Electric traction machines
- Exercise therapy devices
In the event that a massager or vibrator has already been registered as a Notified Medical device prior to December 3rd, 2022, the local manufacturer or importer must register it as a Listing Medical Device before the existing license expires.
Both the Labeling and IFU of a device must meet the criteria set forth by the Notification of the Ministry of Public Health. If these regulations are not complied with, the manufacturer or importer must submit an amendment by November 27th, 2023.
Additionally, the TISI (Thai Industrial Standards Institute) has issued recent regulation on electric massage appliances for household purposes, which can be found here.
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Asia Actual has an office in Bangkok staffed by experienced, bilingual regulatory and commercial professionals to address any questions or provide support. Please contact us to explore if this new program is appropriate for your devices.
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