The medical devices market in Egypt and Saudi Arabia has been growing steadily in recent years, driven by a combination of factors including population growth, rising healthcare spending, and increasing awareness of the importance of healthcare. According to a report by the Business Monitor International, the medical device market in Egypt was valued at $1.5 billion in 2020, and is expected to continue growing in the coming years.
Overall, the medical devices market in Egypt and Saudi Arabia presents significant opportunities for companies that are able to navigate the complex regulatory environment and understand the specific needs and preferences of the local market.
Registration Process of Medical Device in Egypt
1- Documents Submission through the EDA Platform with sample (Normal track Or Fast track).
2- File evaluation, (Accepted or Rejected or Suspended)
3- Initial revision (if accepted)
4- P.V. Evaluation For (class III & IIb devices)
5- Scientific committee Evaluation For (systems & non-reference countries devices)
6- Final revision (after completion of requirements)
7- Technical committee Evaluation.
8- Issuance of Registration License.
Governmental registration fees (EGP)
Services | Fees |
New Registration | 10000 – Normal track |
Re-Registration | 10000 – Normal track |
Variation | 8000 |
PV Evaluation – Normal track | 500 |
PV Evaluation – Fast track | 1000 |
Registration Documents
1- Egyptian Company Documents:
1- Import Record or Scientific office license.
2- Legalized Contract.
3- Legalized relation letter (if found)
4- Company’s representative Delegation.
5- Pharmacovigilance Commitment.
2- Manufacturer Documents :
1- Legalized FDA(CFG) or Free sale certificate (FSC) from Reference Country.
* In case of FSC: plus, Legalized: CE and ISO
* In case of Class III product: plus, Legalized: CE, ISO, and CE DE
2- Declaration of Conformity (DOC).
3- Technical File.
4- Instruction for Use (IFU).
5- Label
6- Sample
7- Pharmacovigilance Commitment.
** Reference Countries regulatory authority: USA, European Medicines Agency (EMA), UK (MHRA), Canada (Healthcanada), Australia, Ireland (HPRA), New Zealand, Japan (PMDA), France, Belgium, Germany, Finland, Norway, Switzerland, Austria, Netherlands, Portugal, Sweden, Iceland, Spain, Italy, Denmark, Luxembourg.
