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Iraq

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Iraq

Medical Device Registration in Iraq

Ministry of Health: 

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

Registration Process:       

  • 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

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