Egypt Regulatory Framework Medical Device registration

Egyptian Medical devices regulation basics

Here below are reported some of the most relevant guidance for Medical Device Registration in Egyptian market:

Major Regulations

Committee Decisions on Registration of Medical Devices, Cosmetics, Household Pesticides and Disinfectants 2011
Medical Device Regulations2010

General Guidance Documents

Documents Required for the Release of Imported Medical Devices 2010

Specific Guidance Documents

Class I Non Sterile Listing SOP and Applications 2010
Egyptian Guidelines for a Medical Device Vigilance System 2013
Requirements for registering imported medical devices in Egypt 2010

Additional Information

Updates to Medical Device Registration Rules 2013


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