The text addresses the inspection and revision requirements for the quality management system of medical devices and supplies factories and establishments in accordance with Royal Decree No. (M/54) and the related Implementing Regulation. The requirements include inspection of factories, authorized representatives, importers, and distributors, with visits categorized into several types: an initial visit to collect information, a visit for licensing purposes, a routine visit to assess compliance,...
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Requirements for Inspections and Audit of Quality Management System (QMS) on Medical Devices Manufacturers and Establishments ( 2025-01-27 )
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Inspection and Revision Requirements for the Quality Management System of Medical Devices and Supplies Factories and Establishments - 2025 ( 2025-01-22 )