Ministry of Health

The Ministry of Health

Regulatory Authority

The Ministry of Health

Official Language

Arabic

Classification

Class I, IIa, IIb and III

Medical Device Registration in Syria

• 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.