Abstract
Medical devices are designed by the manufacturer for use alone or in association with humans for one or more of the specific purposes: diagnosis, prevention, control, treatment, and disease alleviation. Gulf Cooperation Council (GCC) countries are the regional political and economic union including all Arab states of the Persian Gulf—Saudi Arabia, Kuwait, United Arab Emirates (UAE), Qatar, Bahrain, and Oman. The main objectives of the medical device sector are to protect and preserve public health and ensure a high level of safety and health protection. Classification, labeling requirements, fee structure, registration procedure, and different regulatory authorities of medical devices are discussed in this chapter for each GCC country. Saudi Arabia is regulated by Food and Drug Authority, Kuwait is regulated by the Food and Drug Administration of the Department of Health, Qatar is regulated by Ministry of Public Health, Bahrain is regulated by NHRA, and Oman and UAE are regulated by Ministry of health.
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