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SFDA’s Guidance on Requirements for Medical Masks and Particulate Respirators

SFDA has recently published a Guidance on Medical Masks and Particulate Respirators -Recognized Standards; Click here to read the official document. Published on: 26th October, 2020 Highlights from this Document Purpose This guidance document clarifies the requirements for obtaining Medical Devices Marketing Authorization of Medical Masks, in order to place them on the market within…
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SFDA’s Products Classification Guidance

SFDA has recently published a Guidance for Product Classification Criteria; Click here to read the official document. Highlights from this Document Scope This guidance document pertains to a product or category of products that is under the responsibility of each sector within SFDA regulation. Objective This guidance presents the Saudi Food and Drug Authority’s (SFDA’s)…
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SFDA’s Quality Management System Auditing Organizations

SFDA has published a new implementing rule on how Quality Management Auditing Organizations can comply with SFDA’s requirements; Click here to read the official document. Highlights from this Document Article four: Quality Management System Auditing SFDA will perform (if needed) auditing for QMS of the establishment and overseas manufacturer Article five Any auditing organization applying…
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