The Kingdom of Saudi Arabia( KSA) officially introduced a new regulation governing medical devices, which is slated to take effect latterly this year. In affiliated news, the Saudi Food and Drug Authority( SFDA) extended the use of the GHTF expedited market access route and published a guidance document on artificial intelligence in medical software and an updated classification guidance. The first step in preparing a Riyadh, Saudi Arabia device for marketing in the United States is to determine how the FDA has classified your device. A medical device is defined by law in section 201( h) of the Federal Food, Drug and Cosmetic( FD&C) Act. Medical devices in the United States are distributed into one of three classes( I, II, or III), based on the degree of risk they present. As device class increases from class I to class II to class III, the regulatory controls also increase, with class I devices subject to the least regulatory control, and class III devices subject to the most stringent regulatory control. Based on the classification and the regulatory strategy, you must determine if a clinical trial is necessary. Clinical development, clinical trial design, protocol development, and choosing the right CRO […]
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