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
Frequently Asked Questions
Yes. Medical devices need to go through the applicable regulatory registration process before they can be legally marketed in Kuwait.
Medical device regulations in Kuwait fall under the Ministry of Health, with regulatory oversight involving the Drug and Food Control authority.
Yes. Manufacturers selling medical devices in Kuwait may need to appoint a local Authorized Representative to submit applications and communicate with the relevant regulatory authority
The required documents may include an application form, Free Sale Certificate, applicable QMS or GMP certificate, CE documentation, technical product information, labels, package inserts, Declaration of Conformity, and a Letter of Authorization.
Ready to Streamline Your Regulatory Compliance?
Join hundreds of companies who trust OMC Medical for their regulatory needs.
