Medical Device Registration in Kuwait

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:   

Arabic

Classification:        

No defined classification.

Accepts International classification – I, IIa, IIb and III

Registration Process:       

• 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:        

Yes

License Validity:     

5 years

Special Notes:       

Labels or Package Inserts should be in Arabic and English