Medical Devices

SFDA & Ministry of Interior (MOI), Observed some Radiology Deviations in 343 Healthcare Organizations

2015-07-28

SFDA & MOI specialist taskforce observed some deviations in radiology departments ( Diagnostic radiology, nuclear medicine and radiotherapy) in 314 healthcare organizations and 29 dental clinics in the different regions of the Kingdom during the field visits conducted to those organizations.

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Guidance on Innovative Medical Devices (MDS – G002)

2025-01-30
Guidance on Innovative Medical Devices (MDS – G002)
Guide
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Guidance on Requirements of Medical Devices Quality Management System for Distributors, Importers and Authorized Representatives

2019-05-01
Guidance on Requirements of Medical Devices Quality Management System for Distributors, Importers and Authorized Representatives
Guide
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MD Application Imaging Products Importation and Clearance

2019-03-02
MD Application Imaging Products Importation and Clearance
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Vaccine recipient guide for (Pfizer- BioNTech) vaccine

2020-05-12
Vaccine recipient guide for (Pfizer- BioNTech) vaccine
Guide
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Healthcare Provider guide for (Pfizer- BioNTech) vaccine

2020-05-12
Healthcare Provider guide for (Pfizer- BioNTech) vaccine
Guide
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Fees and Review Times for Marketing Authorization Application

Fees and Review Times for Marketing Authorization Application
Publication Date
Applying Date
2017-09-25

Guidance on Importation Requirements for Chemicals Used in Medical Devices Applications

2018-05-23
Guidance on Importation Requirements for Chemicals Used in Medical Devices Applications
Guide
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Guidance on Software as a Medical Device

2018-04-08
Guidance on Software as a Medical Device
Guide
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Requirements for the Import and Clearance of Medical Imaging Materials and Particle Accelerators Used in Radioisotopes Formation for Medical Applications (MDS-REQ 4)

2022-03-24
Requirements for the Import and Clearance of Medical Imaging Materials and Particle Accelerators Used in Radioisotopes Formation for Medical Applications (MDS-REQ 4)
Requirement
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