Medical Device Registration in


Ministry of Health: 

Ministry of Health Kuwait

Regulatory Authority:       

Drug and Food Control

Medical Device Regulation:

Ministerial decree for registration and release of medical devices

Official Language:   



No defined classification.

Accepts International classification – I, IIa, IIb and III

Medical Device Registration in Kuwait:       

  • Determine the device classification
  • Appoint Local Authorized Representative
  • Fill in the application form with the required documents
  • The authorized representative submits the application to the authority
  • Once approved, the device can be marketed in Kuwait

Documents Required:      

  • Application Form
  • Free Sales Certificate
  • Applicable QMS or GMP certificate
  • CE
  • Product Information – Technical Documents
  • Labels, Package Inserts
  • Declaration of Conformity (DoC)
  • Letter of Authorization

Applicable QMS:    

ISO 13485

Registration Timeline:                

6-8 months

Authorized Representative:        


License Validity:     

5 years

Special Notes:       

Labels or Package Inserts should be in Arabic and English



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