Kuwait medical device registration timeline

Planning steps and estimates; these are not regulator deadlines.

• Only the authorized representative of the company holding the marketing rights may file a device registration application; the representative must hold a valid licence from the Ministry of Commerce whose activity includes the sale of medicines, a valid agency licence issued by the Ministry of Health's Pharmaceutical Inspection and Licensing Administration, a valid store licence issued by that same Administration, a copy of the authorized signatories from the Public Authority for Manpower and a copy of the authorized person's legalization from the Kuwait Chamber of Commerce.
• Article 5 of Ministerial Decree No. (387) of 2025 subjects all medical devices and supplies intended to be marketed in Kuwait to registration, and Article 10 entitles the Administration to request additional documents or studies or samples for laboratory analysis during or after registration.
• Three review pathways exist: Standard, Fast-Track and Abridged. The Fast-Track pathway requires a formal request plus at least one qualifying condition, such as a request or valid supply contract from the Central Medical Stores or an essential medical supply need; the Abridged pathway requires approval by a recognised reference authority and a product identical in design, intended use and manufacturing site to the reference-approved product.
• The final decision on accepting an application under the Fast-Track or Abridged pathway is made solely by the Kuwait Medicine and Medical Products Registration and Regulatory Administration after a comprehensive assessment — a reference-authority approval opens an accelerated route, it does not replace the Kuwaiti decision.
• Foreign certificates — the Free Sale Certificate, GMP certificate and ISO certificate from the notified body — must be original and legalized by a Kuwaiti embassy or consulate in the country of origin, or by an authorized GCC embassy or consulate where none exists; the letter of appointment and similar administrative documents must additionally be legalized by the Chamber of Commerce in the country of origin.
• Valid electronic certificates are accepted in place of paper legalization provided an approved verification tool is available for their authentication.
• The class B, C and D device dossier and the IVD dossier require electrical safety and electromagnetic compatibility evidence where applicable, TSE/BSE-free certification for animal-origin material, confirmation that the product does not contain CMR substances, endocrine-disrupting substances or phthalates, a certificate of analysis including microbiological parameters and sterility where applicable, biocompatibility studies, clinical evidence reports and stability studies.
• The class B, C and D device dossier requires one or more product verification and validation documents — an EC/EU product quality management system or product quality assurance certificate from an EU-authorized notified body, an EU technical document assessment or product verification certificate for higher classes, or approval from FDA, TGA, ANVISA, Health Canada, Japan MHLW/PMDA or UK MHRA.
• A renewal application and its required documents must be submitted six (6) months prior to registration expiration.
• A device with a radio interface, or equipment connected to the public telecommunications network, additionally requires a CITRA type approval before it may be used in Kuwait; a CITRA permit to import communications equipment is separately required for importation.
• The Drug and Food Control Administration is the body that approves customs release of any medical preparation arriving in Kuwait from abroad, in addition to holding the device registration.
• Manufacturers must notify the Administration of any change or modification to the product, and the change may not be applied before the Administration approves it.

MDSAP: Accepted as quality-system evidence, not as a review shortcut: the dossier items name an 'ISO 13485 Medical Device QMS / ISO 13485 MDSAP' certificate for the physical manufacturer alongside a GMP certificate issued by a regulatory authority in the country of origin, and either is legalized by a Kuwaiti embassy in the country of origin. The MDSAP certificate satisfies the manufacturer quality-system document; it does not shorten the registration clock and it is not a reference-authority approval, so it does not open the Abridged Review Pathway.

Reviewed 2026-09-16. End-to-end totals remain planning estimates.