FDA is 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 Development, 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.
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 coordination to other groups.
Legislative Process Involvement
FDA 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
1.2 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
FDA 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
FDA constantly conducts and encourages research and development projects in relation to efficacy quality and safety of medical devices.