🇰🇼 Kuwait IVD regulatory data

kuwait:medical-device

kuwait

• medical-device
• ivd

Kuwait classes A, B, C and D — one four-band axis for devices and IVDs

Kuwait uses a single four-class risk axis for medical devices and for in-vitro diagnostic devices alike. Section 8.1(a) of the annex to Ministerial Decree No. (387) of 2025 states that the classification system consists of four classes 'where Class A represents the lowest hazard and Class D the highest', and the section 8.2 class table heads itself 'Proposed general classification system for Medical Devices & IVD Devices' and gives Class A as Low risk, Class B as Low-moderate Risk, Class C as Moderate-high Risk and Class D as High Risk. Classification turns on the manufacturer's intended use and the technology used, the manufacturer must document its justification for the class it chooses, and where two or more rules apply the device is allocated the highest level of classification indicated.

• Id

  a

  Label

  Class A — Low risk

  Normalized Risk Level

  low

• Id

  b

  Label

  Class B — Low-moderate Risk

  Normalized Risk Level

  medium

• Id

  c

  Label

  Class C — Moderate-high Risk

  Normalized Risk Level

  high

• Id

  d

  Label

  Class D — High Risk

  Normalized Risk Level

  highest

Ministry of Health

• moh.gov.kw
• ghc.sa

official-source-verified

• Title

  Gulf Health Council, Guidance on Medical Devices Classification (2026) — Table 1 and Table 2, the GCC-wide class levels for devices and for IVDs

  Url

  https://www.ghc.sa/wp-content/uploads/2026/09/Guidance-on-Medical-Devices-Classification.pdf

  Reviewed On

  2026-09-16

  Supports

  An independent official publication of the same four-band axis from the Gulf Health Council, the GCC body whose central registration regime Kuwait participates in. Table 1 gives Class A Low, Class B Low-Medium, Class C Medium-High and Class D High for devices other than IVDs, and Table 2 gives Class A Low Individual Risk and Low Public Health Risk through Class D High Individual Risk and High Public Health Risk for IVDs. It is carried as corroboration of the axis and of the device/IVD split, not as the Kuwaiti instrument: the operative Kuwaiti text is section 8 of Decree No. (387) of 2025.

Ministerial Decree No. (387) of 2025 on the regulation of the registration and circulation of medical devices and supplies — English annex, section 8 'Classification System for Medical Devices' (8.1 Structure of the Classification Rules and the 8.2 class table)

https://www.moh.gov.kw/UserGuides/387.pdf

2026-09-16

• class-axis
• ivd-class-axis
• classification-rules

Kuwait

kuwait

KW

🇰🇼

Ministry of Health

Ministry of Health

middle-east

3

4-class device and IVD axis (A, B, C, D) — Ministerial Decree No. (387) of 2025, section 8

• Id

  citra-new-type-approval

  Class Name

  CITRA new type approval — radiocommunications equipment

  Pathway

  Application to CITRA with an official letter requesting type approval, the device's technical specifications, a manufacturer's authorization letter, a Declaration of Conformity for region 1 and a lab report from an approved laboratory; review and approval, fee payment, then issue and delivery of the type approval certificate

  Official Timeline

  Min

  20

  Max

  20

  Unit

  working-days

  Verification Status

  official-verified

  Official Source

  Title

  CITRA — Service Details: New Type Approval (SrvcID=44), service fee and duration

  Url

  https://www.citra.gov.kw/sites/en/Pages/ServiceDetails.aspx?SrvcID=44

  Accessed Date

  2026-09-16

  Realistic Timeline

  Min

  1

  Max

  2

  Notes

  • The CITRA service page publishes the duration in the words '20 Business days'. The dataset records it as working days, which is the same published clock on the reading that a business day is a working day; the published wording is quoted here so the mapping is visible rather than silent.
  • This is a CITRA equipment-type-approval clock and is NOT a Ministry of Health device-registration clock. Kuwait's Ministry of Health publishes no device-registration decision clock at all: the annex to Decree No. (387) of 2025 says only that the Standard Review Pathway 'shall undergo a full regulatory assessment in accordance with the applicable requirements, timelines, and procedures defined by' the Administration, and gives no number, and the Fast-Track and Abridged pathway sections give none either. The absence of a Ministry of Health clock is recorded in unresolved.reviewClocks.
  • The clock applies to equipment with a radio interface or connected to the public network, so it reaches only the radio-bearing subset of medical devices and runs alongside, not instead of, device registration.

  Clinical Trial Required

  No

  Local Testing Required

  No

  Gmp Required

  No

• Id

  citra-type-approval-renewal

  Class Name

  CITRA type approval renewal

  Pathway

  Application to CITRA to renew the type approval, with an official letter to renew and a manufacturer's authorization letter; review and approval, fee payment, then issue and delivery

  Official Timeline

  Min

  5

  Max

  5

  Unit

  working-days

  Verification Status

  official-verified

  Official Source

  Title

  CITRA — Service Details: Renew Type Approval (SrvcID=66), service fee and duration

  Url

  https://www.citra.gov.kw/sites/en/Pages/ServiceDetails.aspx?SrvcID=66

  Accessed Date

  2026-09-16

  Realistic Timeline

  Min

  1

  Max

  4

  Unit

  weeks

  Notes

  • The CITRA service page publishes the duration as '5 Business days', recorded here as working days.
  • The renewal fee turns on the transmitter power rather than on the device's risk class: KD 30 for each device with 10 mW output power or less and KD 50 for each device with more power.
  • This is a CITRA clock and not a Ministry of Health device-registration renewal clock; the Ministry publishes none, as recorded in unresolved.reviewClocks.

  Clinical Trial Required

  No

  Local Testing Required

  No

  Gmp Required

  No

• Id

  citra-import-permit

  Class Name

  CITRA permit to import communications equipment

  Pathway

  Application to CITRA with the completed services application form, the device's technical specifications and, where applicable, an authorization letter to CITRA for import of telecom devices naming the importing company; review and approval, then delivery of the authorization

  Official Timeline

  Min

  3

  Max

  3

  Unit

  working-days

  Verification Status

  official-verified

  Official Source

  Title

  CITRA — Service Details: Issuing a permit to import communications equipment (SrvcID=82), duration and fee

  Url

  https://www.citra.gov.kw/sites/en/Pages/ServiceDetails.aspx?SrvcID=82

  Accessed Date

  2026-09-16

  Realistic Timeline

  Min

  1

  Max

  2

  Unit

  weeks

  Notes

  • The CITRA service page publishes the duration as '3 Business days', recorded here as working days, and the service fee as 'Not applicable' — the permit itself carries no charge.
  • The permit authorizes importation in accordance with CITRA's technical rules; it is separate from the Ministry of Health customs-release approval, which the Drug and Food Control Administration describes as its own responsibility for any medical preparation arriving in Kuwait from abroad.
  • This is a CITRA clock and not a Ministry of Health device-registration clock.

  Clinical Trial Required

  No

  Local Testing Required

  No

  Gmp Required

  No

• Authority

  US FDA approval and the EU route — a CE certificate from an EU-authorized notified body

  Accepted

  Yes

  Benefit

  Two of the recognised reference authorities for the Abridged Review Pathway and the first two entries in the class B/C/D dossier's product verification and validation list; an accelerated assessment that still runs under Kuwaiti requirements and post-market obligations, with the acceptance decision reserved to the Administration.

• Authority

  Health Canada, Japan MHLW/PMDA, UK MHRA, Brazil ANVISA and Australia TGA approvals

  Accepted

  Yes

  Benefit

  Also recognised reference authorities under the Abridged Review Pathway, on the same terms as the FDA and EU routes: identical product required, national requirements still assessed, final acceptance decided by the Administration.

• Authority

  Other accredited verification and validation documents

  Accepted

  Yes

  Benefit

  The class B/C/D dossier list closes with an open item for other accredited verification and validation documents, so bodies beyond the named reference authorities can satisfy the evidence item without opening the Abridged Review Pathway itself.

• Authority

  GCC central registration issued by the Gulf Health Council

  Accepted

  No

  Benefit

  No GCC device mutual recognition shortens the Kuwaiti route. The Gulf Health Council's own Medical Devices Central Registration Regulation states at Article (29) that compliance with its provisions, conditions and requirements 'shall not replace any additional requirements in member state', and its Article (7) central registration runs for five years on a separate track. The GCC class axis and the Gulf Health Council's classification guidance are convergent with Kuwait's, which is why the axis is corroborated by them, but neither is a substitute for Kuwaiti registration.

• 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.

Yes

Kuwaiti registered agent / local authorized representative

Yes

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.

No validity period is published. The annex to Ministerial Decree No. (387) of 2025 requires the renewal application and its documents to be submitted six (6) months prior to registration expiration, which establishes that registrations expire and that there is a filing window, but it states no term. The Ministry of Health's own administration page likewise publishes no term. A press summary of an earlier device decree circulating in Kuwait puts the certificate validity at five years, but no retrievable official instrument states that for the 2025 decree, so no term is asserted here — see unresolved.registrationValidity.

2026-09-16

partially-verified

• Title

  CITRA — Service Details: New Type Approval (SrvcID=44), service fee and duration

  Url

  https://www.citra.gov.kw/sites/en/Pages/ServiceDetails.aspx?SrvcID=44

  Accessed Date

  2026-09-16

• Title

  CITRA — Service Details: Renew Type Approval (SrvcID=66), service fee and duration

  Url

  https://www.citra.gov.kw/sites/en/Pages/ServiceDetails.aspx?SrvcID=66

  Accessed Date

  2026-09-16

• Title

  CITRA — Service Details: Issuing a permit to import communications equipment (SrvcID=82), duration and fee

  Url

  https://www.citra.gov.kw/sites/en/Pages/ServiceDetails.aspx?SrvcID=82

  Accessed Date

  2026-09-16

2026-09-16

Template Id

default

Status

planning-template

Usage Rule

Maintained planning steps and estimates, not verified regulator deadlines.

Steps

• Step

  1

  Title

  Pre-Submission Preparation

  Description

  Gather technical documentation, quality management system (QMS) records, and clinical data required by Ministry of Health. Appoint a Kuwaiti registered agent / local authorized representative.

  Duration

  1-3 months

  Icon

  📋

• Step

  2

  Title

  Application Submission

  Description

  Submit complete registration dossier to Ministry of Health including device description, risk analysis, and testing reports.

  Duration

  1-2 weeks

  Icon

  📤

• Step

  3

  Title

  Administrative Review

  Description

  Ministry of Health reviews application for completeness. May request additional documents or clarifications.

  Duration

  2-4 weeks

  Icon

  🔍

• Step

  4

  Title

  Technical Evaluation

  Description

  In-depth technical assessment of device safety and performance. Ministry of Health may issue questions.

  Duration

  20 working days

  Icon

  ⚙️

• Step

  5

  Title

  Registration Approval

  Description

  Upon successful review, Ministry of Health issues Kuwait market authorization certificate.

  Duration

  1-2 weeks

  Icon

  ✅

kuwait

Kuwait

low

• Id

  moh-device-registration-dossier

  Name

  Ministry of Health medical device and IVD registration — full dossier

  Category

  Product Specific Conformity

  Status

  Included In Medical Registration

  Object

  Medical Device Or Ivd

  Note

  The annex to Ministerial Decree No. (387) of 2025 (the decree's own articles are not in the published annex) sets out the dossier by class in its sections 11 to 18: common items include a legalized letter of appointment, the agent licence issued by the Ministry of Health's Pharmaceutical Inspection and Licensing Administration, a legalized original GMP certificate issued by a regulatory authority in the country of origin or an ISO 13485 (medical device QMS or MDSAP) certificate for the physical manufacturer, a legalized original Free Sale Certificate stating that the products are freely sold in the country of origin, and — for the higher classes — product verification and validation documents from a recognised reference body. Legalization must be original, by a Kuwaiti embassy or consulate in the country of origin or by an authorized GCC embassy or consulate where none exists (Chamber-of-Commerce legalization applies only to the letter of appointment and similar administrative documents, section 7); valid electronic certificates are accepted where an approved verification tool exists.

  Source Urls

  • https://www.moh.gov.kw/UserGuides/387.pdf

  Source Binding

  reviewed

• Id

  moh-abridged-pathway-reference-authority-approval

  Name

  Abridged Review Pathway — approval by a recognised reference authority

  Category

  Product Specific Conformity

  Status

  Included In Medical Registration

  Object

  Reference Authority Approval

  Note

  The Abridged Review Pathway is a reliance-based regulatory pathway that enables accelerated assessment of a medical device or IVD by leveraging approval from recognised reference authorities — the annex names FDA, EU member-state approval with a CE certificate, Health Canada, Japan PMDA, UK MHRA, Brazil ANVISA and Australia TGA — combined with national regulatory requirements and post-market obligations. It is not a substitute for review: the product must be identical in design, intended use and manufacturing site to the reference-approved product with no permitted difference in specifications, materials, formulation, performance or manufacturing process, the application is still assessed under the Abridged Review pathway, and section 6.3 states that the final decision on acceptance under both the Fast-Track and the Abridged pathway is made solely by the Kuwait Medicine and Medical Products Registration and Regulatory Administration after a comprehensive assessment of the application and its supporting documentation. The same reference list reappears as dossier item 5, 'Product verification and validation documents', in the class B/C/D and IVD dossier sections.

  Source Urls

  • https://www.moh.gov.kw/UserGuides/387.pdf

  Source Binding

  reviewed

• Id

  moh-device-dossier-electrical-safety-and-emc

  Name

  Electrical safety and electromagnetic compatibility — dossier item, no separate Kuwaiti certificate

  Category

  Medical Electrical Safety

  Status

  Evidence Only No Separate Certificate

  Object

  Electrically Powered Medical Device

  Note

  The Kuwaiti dossier requires 'Electrical safety, and electromagnetic compatibility (if applicable)' as a document of the application — item 11 of the class B/C/D dossier in section 12 and item 10 of the IVD dossier in section 16 — which is evidence filed inside the registration rather than a separate pre-market approval issued by the Ministry of Health. No Kuwaiti low-voltage or EMC order reaching medical devices was retrieved, and no separate scheme is asserted for either: the EMC limb is covered by the same dossier item as the electrical-safety limb rather than by a scheme of its own.

  Source Urls

  • https://www.moh.gov.kw/UserGuides/387.pdf

  Source Binding

  reviewed

• Id

  citra-type-approval

  Name

  CITRA type approval for ICT and radiocommunications equipment

  Category

  Radio Spectrum

  Status

  Mandatory At Import

  Object

  Radiocommunications Or Network Connected Equipment

  Note

  CITRA operates Kuwait's type approval process for telecommunications devices, testing conformity to the technical specifications it publishes. Its power to regulate technical standards and type approval rests on Articles 3(J) and 3(K) and Articles 43, 44 and 45 of Law No. 37 of 2014, and CITRA's technical standards V1.1 states that the Government of Kuwait has established a type approval process for all ICT equipment used within the country and that current ETSI standards as used under the EU Radio Equipment Directive are the standards applied, Kuwait falling in ITU Region 1. The published new-type-approval service requires an official letter to CITRA, the device's technical specifications, a manufacturer's authorization letter, a Declaration of Conformity for region 1 and a lab report from an approved laboratory, and costs KD 50 for each device on a 20-business-day clock; renewal costs KD 30 for each device of 10 mW output power or less and KD 50 above that, on a 5-business-day clock. A device with a radio interface — a Bluetooth or Wi-Fi module, for instance — therefore carries a CITRA approval in addition to Ministry of Health device registration.

  Source Urls

  • https://www.citra.gov.kw/sites/en/Pages/ServiceDetails.aspx?SrvcID=44
  • https://www.citra.gov.kw/sites/en/Pages/ServiceDetails.aspx?SrvcID=66
  • https://www.citra.gov.kw/sites/en/LegalReferences/%D9%84%D8%A7%D8%A6%D8%AD%D8%A9%20%D8%A7%D9%84%D9%82%D9%88%D8%A7%D8%B9%D8%AF%20%D9%88%D8%A7%D9%84%D9%85%D9%82%D8%A7%D9%8A%D9%8A%D8%B3.pdf

  Source Binding

  reviewed

• Id

  citra-import-permit

  Name

  CITRA permit to import communications equipment

  Category

  Import Conformity

  Status

  Mandatory At Import

  Object

  Communications Equipment Shipment

  Note

  CITRA issues an authorization to import telecommunication devices in accordance with the technical rules and regulations, described on the service page as 'Authorization to import telecommunication devices in accordance with the technical rules and regulations'. The published service requires the completed application form, the device's technical specifications and, where applicable, an authorization letter to CITRA for import of telecom devices naming the importing company. The service fee is published as 'Not applicable' and the clock is 3 business days. No fee is charged for this permit — a verified zero, not an unpublished amount.

  Source Urls

  • https://www.citra.gov.kw/sites/en/Pages/ServiceDetails.aspx?SrvcID=82

  Source Binding

  reviewed

• Authority

  Ministry of Health

  Topic

  Ministerial Decree No. (387) of 2025 on the regulation of the registration and circulation of medical devices and supplies — English annex: classification, authorized representative, review pathways, dossier requirements

  Url

  https://www.moh.gov.kw/UserGuides/387.pdf

• Authority

  Ministry of Health

  Topic

  official repository of Ministry of Health ministerial decrees and circulars, which lists Ministerial Decree No. (387) of 2025 and the fee decree No. 278 of 2019

  Url

  https://www.moh.gov.kw/ar/Pages/DCC.aspx

• Authority

  CITRA

  Topic

  service details for a new type approval — required documents, fee of KD 50 for each device, duration 20 business days

  Url

  https://www.citra.gov.kw/sites/en/Pages/ServiceDetails.aspx?SrvcID=44

• Authority

  CITRA

  Topic

  service details for renewal of a type approval — KD 30 for each device with 10 mW output power or less and KD 50 above that, duration 5 business days

  Url

  https://www.citra.gov.kw/sites/en/Pages/ServiceDetails.aspx?SrvcID=66

• Authority

  CITRA

  Topic

  service details for a permit to import communications equipment — required documents, fee not applicable, duration 3 business days

  Url

  https://www.citra.gov.kw/sites/en/Pages/ServiceDetails.aspx?SrvcID=82

• Authority

  CITRA

  Topic

  Technical standards for ICT equipment connected to the public telecommunication network, V1.1 — legal basis for type approval and the standards applied

  Url

  https://www.citra.gov.kw/sites/en/LegalReferences/%D9%84%D8%A7%D8%A6%D8%AD%D8%A9%20%D8%A7%D9%84%D9%82%D9%88%D8%A7%D8%B9%D8%AF%20%D9%88%D8%A7%D9%84%D9%85%D9%82%D8%A7%D9%8A%D9%8A%D8%B3.pdf