Regulation and standards of medical devices in Uganda
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Date
2018
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East African Health Scientific Conference
Abstract
The term “medical devices” includes everything from highly sophisticated computerized medical equipment down to simple wooden tongue depressors (WHO, 2003). The regulation of medical devices is a vast and rapidly evolving field that is often complicated by legal technicalities. Recently it has been observed that improvements on biomedical devices and systems used in diagnosis and treatment of illnesses have progressed parallel to the technological developments. However, the tendency to calibrate, regulate and set standards for health equipment and other biomedical devices is still a puzzle in developing countries like Uganda. Although the consciousness and importance of calibration have reached to a remarkable point in some other national sectors such as industry and trade in the past twenty years, the issue of calibration, regulation and setting of standards has started to be discussed in the past five years for the biomedical devices which are directly related to the health of human beings mainly in East Africa (Rugera, McNerney et al. 2014).
The Global Harmonization Task Force and the international medical devices regulator forum (IMDRF) have proposed the following harmonized definition for medical devices which may be of help in setting standards and regulations ie a Medical device means any instrument, apparatus, implement, machine, appliance, implant, in vitroreagent or calibrator, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purposes of: diagnosis, prevention, monitoring, treatment or alleviation of disease, diagnosis, monitoring, treatment, alleviation of or compensation for an injury, investigation, replacement, modification, or support of the anatomy or of a physiological process, supporting or sustaining life, control of conception, disinfection of medical devices, providing information for medical purposes by means of in vitro examination of specimens derived from the human body and which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.
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Matovu, B. R. I. A. N. (2018, June). Regulation and standards of medical devices in Uganda. In East African Health Scientific Conference.