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.
| Document | Language | Number | Published |
|---|---|---|---|
| Documents Required for the Release of Imported Medical Devices | en | CL-CPM-01 | 2010 |
| 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 |
| Document | Language | Number | Published |
|---|---|---|---|
| Updates to Medical Device Registration Rules (Arabic) | EG-003 | 03/2013 |
Since the publication of ISO 13485:2016, risk management is a major concern for maintaining regulatory compliance in major medical device markets.
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