Medical Device Regulations from Egypt

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


Document	Language	Number	Published
Committee Decisions on Registration of Medical Devices, Cosmetics, Household Pesticides and Disinfectants (Arabic)		EG-001	2011
Medical Device Regulations - DRAFT (Arabic)		CL-RMD-06	12/2010

General Guidance Documents


Document	Language	Number	Published
Documents Required for the Release of Imported Medical Devices	en	CL-CPM-01	2010

Specific Guidance Documents


Document	Language	Number	Published
Class I Non Sterile Listing SOP and Applications (Arabic)		CL-RMD-08	2010
Egyptian Guidelines for a Medical Device Vigilance System (draft)	en	DRAFT	2013
Requirements for registering imported medical devices in Egypt (Arabic)		EG-002	2010

Additional Information


Document	Language	Number	Published
Updates to Medical Device Registration Rules (Arabic)		EG-003	03/2013