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SFDA

05 May 21

SFDA’s Announcement For Extending Of Work Procedures For Medical Device Marketing Authorization (MDMA) requests

SFDA has recently published Extending Of Work Procedures For Medical Device Marketing Authorization (MDMA) requests; Click here to read the official document. Published on: 01st April, 2021 Highlights from this Document Introduction Further to the previous Announcement (1) 12/2020, Receiving newmarketing authorization requests via the GHTF route will be extendeduntil (01/07/2021) AD. According to Royal…
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30 Apr 21

SFDA’s Guidance On Review And Approval Of Artificial Intelligence (AI) And Big Data Based Medical Devices

SFDA has recently published Guidance On Review And Approval Of Artificial Intelligence (AI) And Big Data Based Medical Devices; Click here to read the official document. Published on: 27th April, 2021 Highlights from this Document Scope This guidance applies to the standalone software type of medical devices, to which machinelearning-based AI technology is applied, that…
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19 Jan 21

SFDA’s Requirements For Safe Use Of Mammography

SFDA has recently published Requirements For Mammography; Click here to read the official document. Published on: 12th January, 2021 Highlights from this Document Introduction Mammography is an effective method for screening breast cancer. However, there are safety implications of mammography equipment as they utilize X-rays, which are potentially dangerous, to produce images. Screening mammography services…
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19 Jan 21

SFDA’s Requirements For Safe Use Of Medical Ultraviolet Radiation

SFDA has recently published Requirements For Safe Use Of Medical Ultraviolet Radiation; Click here to read the official document. Published on: 12th January, 2021 Highlights from this Document Introduction Ultraviolet radiation (UVR) is the band of non-ionizing radiation that lies between the ionizing radiation and the visible radiation (light) electromagnetic spectrum. The UVR wavelength range…
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19 Jan 21

SFDA’s Guidance For Medical Device Maintenance Facilities

SFDA has recently published a Guidance For Medical Device Maintenance Facilities; Click here to read the official document. Published on: 12th January, 2021 Highlights from this Document Purpose This guidance is to clarify the Saudi Food & Drug Authority (SFDA) requirements on the maintenance services of medical devices and supplies in health facilities to ensure…
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14 Jan 21

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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07 Jan 21

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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07 Jan 21

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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