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
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 |