Introduction
In the past, when there was no law relating to medical device control, the Ministry of Public Health normally solved the problems pertaining to medical devices by referring to the provisions of the Drug Act. The terminology and control measures in the Act were often found not pertinent to the fact and nature of medical devices, which are instruments or apparatus, not medicines. Moreover, upon application of the Drug Act to medical devices whose technology has been increasingly advanced, we often came across the limitation of the Act. This limitation caused the control and quality assurance of medical devices to be insufficient and inefficient. To ensure effective control of quality, efficacy and safety of medical devices emerging with the technological advancement, the Medical Device Act of B.E. 2531 (1988) was enacted and has become effective since May 23, 1988.
On August 3, 1988, an ad hoc task force was appointed within the FDA to implement the Act and to take responsibilities for the control of medical devices. On June 22, 1990, the Medical Device Control Division was officially established and has since been recognized as an authoritative agency under the FDA. Now about 25 pharmacists work for this Division.
The activities under the above Act are conducted under the supervision of the Medical Device Committee, which gives consent and advice, and makes recommendations to the Secretary-General of the Food and Drug Administration.
