Egypt Medical Device Regulations

Egypt's Ministry of Health and the Committee on Registration of Medical Devices have issued some important decisions regarding registration of medical devices, shown below. All documents are in PDF format. 

Major Regulations

DocumentLanguageNumberPublished
Committee Decisions on Registration of Medical Devices, Cosmetics, Household Pesticides and Disinfectants (Arabic) EG-0012011
Medical Device Regulations - DRAFT (Arabic) CL-RMD-0612/2010

General Guidance Documents

DocumentLanguageNumberPublished
Documents Required for the Release of Imported Medical Devicesen CL-CPM-012010

Specific Guidance Documents

DocumentLanguageNumberPublished
Class I Non Sterile Listing SOP and Applications (Arabic) CL-RMD-082010
Egyptian Guidelines for a Medical Device Vigilance System (draft)en DRAFT2013
Requirements for registering imported medical devices in Egypt (Arabic) EG-0022010

Additional Information

DocumentLanguageNumberPublished
Updates to Medical Device Registration Rules (Arabic) EG-00303/2013