Egypt Regulatory Framework Medical Device registration
Egyptian Medical devices regulatory 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
Document | Year |
| Documents Required for the Release of Imported Medical Devices | 2010 |
Specific Guidance
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 |
Regulation | Year |
| Committee Decisions on Registration of Medical Devices, Cosmetics, Household Pesticides and Disinfectants | 2011 |
| Medical Device Regulations | 2010 |
Document | Year |
| Documents Required for the Release of Imported Medical Devices | 2010 |
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 |
Document | Year |
| Updates to Medical Device Registration Rules | 2013 |
