Kuwait presents significant opportunities for foreign pharmaceutical and medical device manufacturers, with heavy reliance on imports and growing demand for advanced healthcare products.
The Kuwait Drug and Food Control Administration (KDFCA), under the Ministry of Health, regulates medicines, medical devices, cosmetics, and food products through stringent licensing, registration, and approval processes. Foreign companies must navigate complex local requirements for product registration, import permits, and compliance to successfully enter and operate in the market. MedWisdom LifeScience provides expert regulatory affairs support, offering tailored consultations, strategic guidance, and comprehensive services to help global manufacturers overcome regulatory challenges, secure necessary approvals, and achieve efficient, compliant market entry in Kuwait.
Get Kuwait Compliance Support
Comprehensive preparation of regulatory dossiers, including CTD format compilation, supporting data, and KDFCA-specific documentation for product registration.
Seamless conversion and technical validation of dossiers from CTD to eCTD format, ensuring compliance with electronic submission standards accepted by KDFCA.
Management of full regulatory submissions to KDFCA, including new registrations, renewals, variations, and ongoing lifecycle maintenance.
Development of customized market entry plans, pricing & reimbursement strategies, distributor engagement, and regulatory pathway optimization for Kuwait.
Arabic/English labeling review, KDFCA-specific requirements (including artwork, patient information, and packaging standards), mock-ups, and approval support.
Preparation and submission of clinical trial applications to KDFCA/Ministry of Health, including protocol review, ethics committee coordination, and regulatory follow-up.
Implementation of PMS plans, adverse event reporting, vigilance compliance, field safety corrective actions, and ongoing monitoring per KDFCA requirements.
Customized regulatory training for internal teams, distributor support, workshops on KDFCA processes, and ongoing advisory services for sustained compliance.
Partner with Medwisdom for expert, tailored, and fully compliant regulatory support in Kuwait — from dossier preparation and KDFCA submissions to market access, post-market surveillance, and long-term success.
Contact Our Kuwait Regulatory Experts