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Egyptian Medical devices regulation basics
Here below are reported some of the most relevant guidance for Medical Device Registration in Egyptian market:
Major Regulations
Regulation Year Committee Decisions on Registration of Medical Devices, Cosmetics, Household Pesticides and Disinfectants 2011 Medical Device Regulations 2010 General Guidance Documents
Document Year Documents Required for the Release of Imported Medical Devices 2010 Specific Guidance Documents
Document Year 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
Document Year Updates to Medical Device Registration Rules 2013 Doubts?
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Doubts ?
Reach out to us and we will help you clarify your situation
