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SFDA’s Announcement About Detailed Fees For Updating Medical Device Marketing Authorization (MDMA) Applications.

SFDA has recently announced the detailed fees for updating medical device marketing authorization (MDMA) applications; Click here to read the official document. Published On: 13 January 2021 Highlights from this Document Purpose This announcement would like to clarify the detailed fees for updating Medical Device Marketing Authorization (MDMA) applications. Scope This guidance applies to local…
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SFDA’s Draft Guidance of Requirements of Licensing Service Providers for Quality Assurance and Ionizing Radiation Measurements in Healthcare Facilities.

SFDA has recently published the Draft Guidance of Requirements of Licensing Service Providers for Quality Assurance and Ionizing Radiation Measurements in Healthcare Facilities; Click here to read the official document. To post your comments on this DRAFT, please use the message box below Highlights from this Document Purpose This guidance is intended to clarify SFDA…
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SFDA’s Draft Guidance of Importation and Re-Exploration for Radioactive Materials Used In Medical Applications

SFDA has recently published the Draft Guidance of Importation and Re-Exploration for Radioactive Materials Used In Medical Applications; Click here to read the official document. To post your comments on this DRAFT, please use the message box below Highlights from this Document Purpose This guidance is intended to clarify SFDA Requirments of importation and re-exportation…
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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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