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Syria

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?