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
MD Application Imaging Products Importation and Clearance
2019-03-02
MD Application Imaging Products Importation and Clearance
Vaccine recipient guide for (Pfizer- BioNTech) vaccine
2020-05-12
Vaccine recipient guide for (Pfizer- BioNTech) vaccine
Guide
Healthcare Provider guide for (Pfizer- BioNTech) vaccine
2020-05-12
Healthcare Provider guide for (Pfizer- BioNTech) vaccine
Guide
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
Guidance on Software as a Medical Device
2018-04-08
Guidance on Software as a Medical Device
Guide
Requirements for the Import and Clearance of Medical Imaging Materials and Particle Accelerators Used in Radioisotopes Formation for Medical Applications
2022-03-27
Requirements for the Import and Clearance of Medical Imaging Materials and Particle Accelerators Used in Radioisotopes Formation for Medical Applications
Guide
Requirements for SFDA Approval of Technical and Clinical Specifications of Radioactive Medical Materials (MDS-REQ 6)
2023-07-18
Requirements for SFDA Approval of Technical and Clinical Specifications of Radioactive Medical Materials (MDS-REQ 6)
Requirement
extending deadline for receiving requests for marketing authorization applications via GHTF route
extending deadline for receiving requests for marketing authorization applications via GHTF route