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April 26, 2011

New FDA Requirements for Selected Medical Devices

The Thai Food and Drug Administration has recently released an announcement regarding the control of static devices/chairs, electrical massage beds, and direct current devices for soaking feet. All business operators who produce, import, or sell these products, which are classified as “Notification Medical Devices” in Thailand, are required to submit additional documents in order to register new products or continue to import and sell already-registered products. The additional documents are as follows:

  1. Test results and analytical methods in accordance with IEC 60601 (International Standard of Medical Electrical Equipment).
  2. Result of clinical trials which support the product’s indications and benefits.

This requirement was introduced for these goods because the Thai FDA is concerned about the possibility of consumers being deceived and being subject to dangerous electric currents in nonstandard equipment. The FDA has already suspended the import of these products by four companies until these companies submit the required documents.

It is therefore essential that producers, importers, and distributors of these products immediately take action to submit the required documents to the FDA.  If you wish to receive more information about these requirements, please contact us at [email protected].