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.

Want to know more about this registration process?