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Kuwait medical device registration resources

Research Ministry of Health registration records, classification, regulations, timelines, fees, and market updates — the stable entrance to every Kuwait medical device resource.

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Structured regulatory requirements

Explore all 5 source-linked facts

5 of 25 research dimensions currently covered · 10 official sources · latest verification 2026-09-16

Market entry

D01

Authority & regime

Verified
Ministry of Health is the issuing authority of the medical-device registration decree, as recorded in the Official Gazette
The instrument that carries Kuwait's medical device registration framework — Ministerial Decree No. 387 of 2025 — was issued by the Kuwait Ministry of Health (وزارة الصحة) and published in…
1 source-linked fact
Checked 2026-09-16
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D02

Legal basis & guidance

Verified
Ministerial Decree No. 387 of 2025 published in Official Gazette No. 1773 on 11 January 2026
Ministerial Decree No. 387 of 2025 was published by the Kuwait Ministry of Health in the Official Gazette Kuwait Al Youm, main edition No. 1773 of 11 January 2026 (22 Rajab 1447 H), at page…
1 source-linked fact
Checked 2026-09-16
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D03

Device definition & scope

Unresolved

No source-verified answer is published for this dimension yet.

0 source-linked facts
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D04

Classification rules

Verified
Kuwait classes A, B, C and D — one four-band axis for devices and IVDs
Class A — Low risk, Class B — Low-moderate Risk, Class C — Moderate-high Risk, Class D — High Risk
1 maintained scheme
Checked 2026-09-16
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D05

Registration pathways

Unresolved

No source-verified answer is published for this dimension yet.

0 source-linked facts
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D06

Reliance & recognition

Verified
GCC central registration through the Gulf Health Council does not replace Kuwaiti national registration
statement: The Gulf Health Council operates a central registration system for medical devices and issues a medical device central registration valid for five years from the date of issuance…
1 source-linked fact
Checked 2026-09-16
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D07

Economic-operator roles

Unresolved

No source-verified answer is published for this dimension yet.

0 source-linked facts
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D08

Establishment, import & distribution

Verified
Customs release of a consignment of non-ionizing-radiation devices needs a Ministry of Health release approval, conditional on a prior import licence
A consignment of devices operating with non ionizing radiation that is listed in a customs declaration is released only with the approval of the Kuwait Ministry of Health. The service is fi…
Importing a device that operates with non-ionizing radiation needs a Ministry of Health import licence, including for devices used in the medical field
A company or establishment that imports a device operating with non ionizing radiation must obtain an import licence from the Kuwait Ministry of Health. The service page states the scope as…
2 source-linked facts
Checked 2026-09-16
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D09

Dossier requirements

Unresolved

No source-verified answer is published for this dimension yet.

0 source-linked facts
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D10

Official forms & portals

Unresolved

No source-verified answer is published for this dimension yet.

0 source-linked facts
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Submission & evidence

D11

Label, IFU & language

Unresolved

No source-verified answer is published for this dimension yet.

0 source-linked facts
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D12

QMS, audit & inspection

Unresolved

No source-verified answer is published for this dimension yet.

0 source-linked facts
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D13

Standards, testing & ancillary approvals

Unresolved
Ministry of Health medical device and IVD registration — full dossier
Product-specific
Abridged Review Pathway — approval by a recognised reference authority
Product-specific
Electrical safety and electromagnetic compatibility — dossier item, no separate Kuwaiti certificate
Electrical safety
5 maintained overlays
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D14

Fees

Unresolved

No source-verified answer is published for this dimension yet.

0 source-linked facts
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D15

Review clocks

Unresolved
CITRA new type approval — radiocommunications equipment · 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
20 working days
CITRA type approval renewal · 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
5 working days
CITRA permit to import communications equipment · 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
3 working days
3 maintained pathways
Checked 2026-09-16
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D16

Approval validity & renewal

Unresolved

No source-verified answer is published for this dimension yet.

0 source-linked facts
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Lifecycle & post-market

D17

Change control

Unresolved

No source-verified answer is published for this dimension yet.

0 source-linked facts
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D18

UDI, listing & traceability

Unresolved

No source-verified answer is published for this dimension yet.

0 source-linked facts
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D19

Clinical investigation & performance

Unresolved

No source-verified answer is published for this dimension yet.

0 source-linked facts
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D20

Special access & derogation

Unresolved

No source-verified answer is published for this dimension yet.

0 source-linked facts
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D21

Manufacturer PMS

Unresolved

No source-verified answer is published for this dimension yet.

0 source-linked facts
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D22

Vigilance & incident reporting

Unresolved

No source-verified answer is published for this dimension yet.

0 source-linked facts
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D23

Recall, FSCA & market surveillance

Unresolved

No source-verified answer is published for this dimension yet.

0 source-linked facts
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D24

Advertising, claims & promotion

Unresolved

No source-verified answer is published for this dimension yet.

0 source-linked facts
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D25

Submission communications & appeal

Unresolved

No source-verified answer is published for this dimension yet.

0 source-linked facts
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Registration timeline

Full registration timeline

Ministry of Health (Ministry of Health) review clocks and planning ranges · 4-class device and IVD axis (A, B, C, D) — Ministerial Decree No. (387) of 2025, section 8 classification

Class / pathwayReview clockPlanning totalProvenance
CITRA new type approval — radiocommunications equipment(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)20 working days1-2 monthsVerified
CITRA type approval renewal(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)5 working days1-4 weeksVerified
CITRA permit to import communications equipment(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)3 working days1-2 weeksVerified
  1. 1Pre-Submission Preparation(1-3 months)
  2. 2Application Submission(1-2 weeks)
  3. 3Administrative Review(2-4 weeks)
  4. 4Technical Evaluation(20 working days)
  5. 5Registration Approval(1-2 weeks)

Official Ministry of Health rules and guidance · 2 of 2 documents linked to official sources

Medical Device Central Registration Regulation, Issue 1.0Medical Device Central Registration Regulation (Gulf Health Council)
RegistrationVerified
Medical Devices Registration Technical File Requirements, version 1.0Medical Devices Registration Technical File Requirements
RegistrationVerified
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