Kuwait Medical Device Registration
Kuwait's medical device market is evolving in alignment with international rules and standards, presenting opportunities for growth and development within the sector. The Ministry of Health , Drug and Food Control (MoH), through its Pharmaceutical and Herbal Medicines Control and Registration Administration regulates medical devices and In-Vitro Diagnostics (IVD) marketed in Kuwait.
In September 2022, Kuwait's Ministry of Health introduced three new ministerial decrees aimed at regulating the field of medical devices. The initial decree, Ministerial Decree No. 13 of 2022, specifically addresses the registration and distribution processes for medical devices. These requirements are adopted from the European Council Directives for medical devices 93/42/EEC and active implantable medical devices 90/385/EEC and from guidelines issued by the International Medical Device Regulators Forum (IMDRF).
Medical Device Regulatory Requirements for Kuwait Market Entry
| Authority | Ministry of Health (MOH) through its Pharmaceutical and Herbal Medicines Control and Registration Administration |
| Regulation | M.D. (13)/2022[1] |
| Classification | Medical devices and IVDs are classified into four classes (A, B, C and D) |
| Validity of license | 5 years |
Navigate Kuwait's medical device regulations effortlessly with our MDV consultants. Ensure smooth market entry and success. Limited slots available—contact us now!
Freyr Competencies for Kuwait market entry
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Regulatory Intelligence and Due-Diligence Services in Kuwait![]()
Medical Device Classification Support in Kuwait![]()
Device Registration![]()
Kuwait Authorized Representation![]()
Translation support![]()
Labeling Support![]()
Distributor identification and qualification![]()
License renewal and transfer![]()
Customs clearance![]()
Post-Market Surveillance
Frequently Asked Questions (FAQs)
You must confirm that there has been no change in the product's composition, specification, shelf life, and other parameters since registration. If there are changes, you need to submit a copy of variation approvals from the Pharmaceutical and Herbal Medicine Control and Registration Administration.
Yes. The license is transferrable. This requires original legalized termination letter of the old agent and legalized letter of appointment of new local agent, along with the list of registered product. Only medical device with valid registration will be transferred.
Renewal applications and required documents should be submitted 6 months before the registration's expiration.
Medical Device Regulatory Consulting – Proven Expertise
Why Freyr?
- Independent Representation and Regulatory Support.
- Continuous Liaison with the Agency for Submissions, Queries, and Feedback.
- Single Point of Contact in the Country for Liaison with the Regulatory Agency.