Egypt Medical Device Regulations

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Major Regulations
Document Number Published Language
Download Medical Device Regulations - DRAFT (Arabic) CL-RMD-06 12/2010
Download Committee Decisions on Registration of Medical Devices, Cosmetics, Household Pesticides and Disinfectants (Arabic) EG-001 2011
General Guidance Documents
Document Number Published Language
Download Documents Required for the Release of Imported Medical Devices CL-CPM-01 2010 English
Specific Guidance Documents
Document Number Published Language
Download Requirements for registering imported medical devices in Egypt (Arabic) EG-002 2010
Download Class I Non Sterile Listing SOP and Applications (Arabic) CL-RMD-08 2010
Download Egyptian Guidelines for a Medical Device Vigilance System (draft) DRAFT 2013 English
Additional Information
Document Number Published Language
Download Updates to Medical Device Registration Rules (Arabic) EG-003 03/2013