Guidelines

Date
2023-09-28
Medical Devices Guide
Guidance on SFDA Requirements for Quality Assurance Programs for Radiation Emitting and Imaging Devices (MDS-G15)
2023-03-22
Medical Devices Guide
Guidance on MDMA –Significant and Non-Significant Changes (MDS-G012)
2023-01-03
Medical Devices Guide
Guidance for Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices (MDS – G010)
2022-03-27
Medical Devices Guide
Requirements for the Import and Clearance of Medical Imaging Materials and Particle Accelerators Used in Radioisotopes Formation for Medical Applications
2019-05-01
Medical Devices Guide
Guidance on Requirements of Medical Devices Quality Management System for Distributors, Importers and Authorized Representatives
2018-05-23
Medical Devices Guide
Guidance on Importation Requirements for Chemicals Used in Medical Devices Applications
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