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Drug Control Division Food Control Division Narcotics Control Division Medical Device Control Division Cosmetic Control Group Hazardous Substances Control Group Supportive Group

Laws and Regulations

Definitions of terms

The 1988 Medical Device Act has noted a number of significant points (Section 3).

“Medical device” is defined as:

  1. an instrument, product, or article that is used for medical practice, nursing, midwifery practice, general medical or veterinary practice, in pursuance of the governing laws;
  2. an instrument, product, or article that is used to affect health structure or any physiological function of human or animals;
  3. a constituent, component, part, accessory or part of instrument, product or article prescribed in (1) or (2);
  4. other instruments, products or articles notified in the Government Gazette by the Minister as medical devices.

Section 36 of the Medical Device Act prohibits manufacture, import or sale of the following devices:

  1. fake devices;
  2. substandard devices;
  3. deteriorated devices;
  4. unsafe devices.

A fake medical device , according to Section 37 of the Act, is a device characterized in any of the following categories:

  1. a device which is imitatively made or copied, whether in part or as a whole;
  2. a device whose name, category, feature, or brand name as shown is inconsistent with its licence or with the details notified to the grantor;
  3. a device whose name of producer, place of origin, manufacturing date, or location of production shown is different from the fact.

A substandard device , according to Section 38, is a device whose quality does not comply with the standard requirements as specified by virtue of Section 35(2) of the Act.

A deteriorated device , according to Section 39, is a device whose quality and/or performance is below its standard requirements, or a device that has already expired.

An unsafe device , according to Section 40, is a device characterized in any of the following categories:

  1. a device that is designed for being disposed of after use;
  2. a device produced or stored unhygienically;
  3. a device that is contaminated;
  4. a device that consists of decomposed substances that might cause intoxication and do harm to users;
  5. a device whose liability or efficacy is doubtful.

Control of Medical Devices

Control of medical devices is categorized into three main levels:

  • general control,
  • pre-marketing notification, and
  • pre-marketing approval.
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