Medical Devices

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

2022-03-27
Requirements for the Import and Clearance of Medical Imaging Materials and Particle Accelerators Used in Radioisotopes Formation for Medical Applications
Guide
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Requirements for Approval of Technical and Clinical Specifications of Medical Radioactive Materials (MDS-REQ 6)

2026-01-08
Requirements for Approval of Technical and Clinical Specifications of Medical Radioactive Materials (MDS-REQ 6)
Requirement
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extending deadline for receiving requests for marketing authorization applications via GHTF route

extending deadline for receiving requests for marketing authorization applications via GHTF route
Publication Date
Applying Date
2020-12-28
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