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SFDA

SFDA’s Guidance on Importation Requirements of Medical Devices Intended for Demonstration or Training Purpose only.

SFDA has recently published a Guidance on the requirements of Medical Devices Intended for Demonstration or Training Purpose only; Click here to read the official document. Published on: 27th December, 2020 Highlights from this Document Purpose This guidance is intended to specify the requirements for obtaining an importation license for medical devices intended for demonstration…
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SFDA’s Guidance on Import and Clearance Requirements for Particle Accelerators

SFDA has recently published a Guidance on the requirements of Import and Clearance for Particle Accelerators Used in Radioisotope Formation for Medical Applications; Click here to read the official document. Published on: 15th November, 2020 Highlights from this Document Purpose This guidance is intended to clarify SFDA requirements of importation and clearance of particle accelerators…
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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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