Thailand FDA Provides Guidance on Classification of Physical Therapy Devices

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.

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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)