FDA Thailand
Thai Version
FDA Thailand Home Contact FDA Thailnad Thai Version Thai Version
FDA Thailand Home
Contact FDA Thailnad
FDA Thailand Home About FDA Thailand About FDA Thailand Contact FDA Thailnad Contact FDA Thailnad
Contact FDA Thailnad FDA Site Map FDA Site Map
About FDA Thailand FDA Site Map
About FDA Thailand
Drug Control Division Food Control Division Narcotics Control Division Medical Device Control Division Cosmetic Control Group Hazardous Substances Control Group Supportive Group

System Development

We are in charge of 6 main responsibilities which are 1) Division Action Plan Making 2) Division Budget Formulation 3) Legislative Process Involvement 4)Medical Device Categorization 5) Human Resource Deve- lopment and 6) Research and Development Involvement

Action Plan Making

The staff makes an annual action plan in consistence with the National Public Health Policy. Responsibilities includes

  • reviews, analyzes, edits, consolidates and justifies the action plan
  • tracks and monitors performance of each group in a maner consistent with the FDA intent and the division action plan, and
  • analyzes and presents annual division performance to the FDA.

Budget Formulation

The staff plans, organizes, and carries out annual year division bugeting in full compliance with the medical device control activities administered by the FDA. Responsibilities include

  • reviews, analyzes, edits, consolidates and justifies budget estimates
  • develops detailed strategy and background documentation for presenting all the activities of the division budget
  • ensures that the budget is utilized in a maner consistent with the FDA intent and the division mission, and
  • provides financial management consultations and coordinations to other groups.

Legislative Process Involvement

We are involved in legislative process by enacting amending and revising Medical Device Act, relevant Ministerial Regulations and Ministerial Notifications to be submitted to Medical Device Committee for an approval.

Medical Device Categorization

Nowadays, certain health products available in the market cannot be definitely categorized as drug, medical device, or cosmetics. Those who wish to have any product categorized if it is medical device and if so, what type of medical device it is shall file an application for product categorization together with required documentation to the Medical Device Control Division.

For categorization of product as medical device, one needs to take into consideration the definition of “Medical Device ” given in the Medical Device Act, B.E. 2531

In attempt of medical device control, the Ministry of Public Health has issued announcements on licensing, or report on manufacture, import or free sale of medical device. This leads to necessity of categorization if a product to be manufactured, imported, or sold is medical device and if so, what type of medical device it is. Up to the present, the Ministry of Public Health has required license or report for the following medical devices

1. Medical Device To Be Licensed

1.1 Condom

1.2 Examination glove

1.3 Surgical glove

1.4 Disposable hypodermic hygienic syringe

1.5 Disposable insulin syringe

1.6 HIV test for diagnosis, screening

2 Medical Device To Be Notified

2.1 HIV Test for other purposes

2.2 Medical equipment for physical therapy

2.3 Alcohol-Detector test equipment

2.4 Implant silicone breast

Human Resource Development

We are committed to continuous improvement of the capability of all staff by setting up Human Resource Development Programs which allow all the staff throughout the division to enhance their abilities needed for their jobs.

Research and Development Involvement

We constantly conduct and encourage research and development projects in relation to efficacy quality and safety of medical devices.

Food Control Division Drug Control Division FDA Thailand Home Cosmetic Control Group Supportive Goup Hazardous Substances Control Group Medical Devices Control Division Narcotic Control Division
Visitor No. Since 21 October 2004