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