Medical Device Registration in
Iraq
Ministry of Health:
Regulatory Authority:
State Company for Marketing Drugs and Medical Appliances (KIMADIA)
Medical Device Regulation:
No defined regulation
Official Language:
Arabic
Classification:
Class A, B, C and D
Medical Device Registration in Iraq:
- Determine device classification
- Appoint Authorized Representative
- Prepare the application form and required documents
- Submit it to KIMADIA
- Once approved, the device can be marketed.
Documents Required:
- The company registration form
- QMS certificate
- Company product list
- Raw material certification letter & country of origin of raw material
- Copy of commercial invoice
Legalized/Notarised Documents (if any)
Manufacturer registration certificate
Letter of Authorization
Applicable QMS:
ISO 13485 or 9001
Registration Timeline:
90 days
Authorized Representative:
Yes