Medical Device Registration in
Syria
Ministry of Health
The Ministry of Health
Regulatory Authority
The Ministry of Health
Official Language
Arabic
Classification
Class I, IIa, IIb and III
Registration Process
- For registration, the following documents should be legalized by the Chamber of Commerce and the Syrian embassy in the country of origin.
- Prepare the technical documentation and submit it to MoH
- Once approved, an import license will be issued to the Manufacturer
Documents Required
- Technical Documents
- Manufactures company registration certificate
- CE mark or US FDA certificate
- Certificate of Free Sales
- QMS certificate
- Testing Reports
Legalized/Notarised Documents (if any)
- Manufactures company registration certificate
- CE mark or US FDA certificate
- Certificate of Free Sales
- QMS certificate
Applicable QMS
ISO 13485
Registration Timeline
1 month for company registration + the time required for testing
Authorized Representative
Yes
License Validity
Based on authorization expiry from the Country of Origin
Special Notes
- Import of refurbished medical equipment is prohibited.