Kuwait Medical Device & IVD Registration: Complete FAQ Guide (2026 Update)

Prepared by OMC Medical | Global Regulatory Consulting Partner

At OMC Medical, we support global manufacturers in successfully registering their medical devices and IVDs in Kuwait in full compliance with the Kuwait Ministry of Health (MOH) requirements under the Medicine and Medical Products Registration and Regulatory Administration (MMPRRA).

This practical FAQ is designed for manufacturers, brand owners, and distributors planning market entry into Kuwait.

1. Who is the regulatory authority for medical devices in Kuwait?

Medical devices and IVDs are regulated by the Kuwait Ministry of Health (MOH) through the Medicine and Medical Products Registration and Regulatory Administration (MMPRRA), in accordance with Ministerial Decree MD (387/2025).

2. Is medical device registration mandatory in Kuwait?

Yes. All medical devices and IVDs must be registered with the MOH before importation, marketing, or distribution in Kuwait, for both public and private sectors.

3. Do foreign manufacturers need a local Authorized Representative?

Yes. Foreign manufacturers must appoint a Local Authorized Representative (AR) established in Kuwait. The AR represents the manufacturer before the MOH for: 

• Product registration 
• Importation approvals 
• Post-market surveillance (PMS) 
• Regulatory communication and variations 
  
  

OMC Medical assists in coordinating with compliant and MOH-approved local agents.

4. Who qualifies as an Authorized Representative in Kuwait?

The Authorized Representative must: 

• Be a legal entity established in Kuwait 
• Hold a valid Ministry of Commerce license 
• Hold an Agent License and Store License from the Pharmaceutical Inspection & Licensing Administration 
• Be approved by the MOH for medical device activities 

5. What products fall under Kuwait’s medical device regulation?

The regulation applies to: 

• Medical Devices 
• In Vitro Diagnostic (IVD) Devices 
• Accessories to medical devices 
• Medical device software (standalone or embedded) 
• Substance-based medical devices (non-pharmacological action) 

6. How are medical devices classified in Kuwait?

Kuwait follows an IMDRF-aligned, risk-based classification:

• Class A – Low risk 
• Class B – Low to moderate risk 
• Class C – Moderate to high risk 
• Class D – High risk
  
  Classification is based on intended use, duration of use, invasiveness, and risk. OMC Medical provides formal classification assessments to prevent rejections and delays.

7. How are IVD devices classified?

IVDs are classified into Class A, B, C, or D based on public health risk, individual risk, and intended diagnostic purpose, aligned with international IVDR principles.

8. What registration pathways are available in Kuwait?

Kuwait provides three regulatory pathways:
• Standard Review Pathway – Full technical review for all device classes
• Fast-Track Review Pathway – For critical, ICU, life-saving, or CMS-requested products
• Abridged Review Pathway – Reliance-based pathway using approvals from reference authorities

OMC Medical advises on the fastest and most cost-effective pathway for each product.

9. Which reference approvals are accepted by Kuwait MOH?

Recognized reference authorities include:

• US FDA (CDRH) 
• EU CE Marking 
• UK MHRA (UKCA) 
• Health Canada 
• TGA Australia 
• PMDA / MHLW Japan 
• ANVISA Brazil 
  
  

10. Can multiple products be submitted under one application?

Yes, subject to bundling rules:

• Medical Device Family 
• Medical Device System 
• Procedure Pack 
• IVD Device Pack 

A maximum of 50 items per application is allowed, subject to MOH acceptance. OMC Medical evaluates bundling eligibility to optimize cost and timelines. 

11. What technical documentation is required?

Kuwait requires Summary Technical Documentation (STED) aligned with IMDRF, including: Device description and intended use 

• Risk classification justification 
• Essential Principles checklist 
• Risk management and benefit-risk analysis 
• Clinical evidence / performance data 
• Labeling and IFU 
• ISO 13485 and/or regulatory approvals 
  
  

12. Are documents required to be legalized?

Yes. Documents such as:

• Free Sale Certificate 
• ISO 13485 Certificate 
• CE Certificate 
• Letter of Authorization 
  
  

must be original and legalized by the Kuwait Embassy (or authorized GCC embassy), unless valid electronic verification is available. 

13. Are electronic certificates accepted?

Yes. Electronic certificates and e-legalization are accepted if official verification is available.

14. What is STED and why is it important?

STED (Summary Technical Documentation) demonstrates conformity with Essential Principles of Safety and Performance and is mandatory for most Class B, C, and D devices.

15. How long does registration take?

Indicative timelines:

• Standard Review: 6–9 months 
• Abridged Review: 3–6 months 
• Fast-Track Review: Case-dependent 

Timelines depend on dossier quality and regulatory queries. OMC Medical focuses on first-cycle approvals to minimize delays. 

16. Is renewal of registration required?

Yes. Registrations must be renewed periodically with updated documents per MOH requirements.

17. Can registered products be changed?

Yes. Variations such as labeling, IFU, manufacturing site, design, or distributor changes require prior MOH approval.

18. What are the consequences of non-compliance?

MOH may:

• Suspend the registration 
• Cancel the registration 
• Request corrective and preventive actions (CAPA) 
• Block importation 
  
  

19. Are post-market surveillance obligations mandatory?

Yes. Manufacturers and ARs must:

• Report adverse events and recalls 
• Maintain a PMS system 
• Notify the MOH of global safety actions 
  
  

20. Can an agency or distributor be transferred?

Yes. Transfer of agency is permitted, subject to MOH approval and documentation review.

How OMC Medical Supports Your Kuwait Market Entry

OMC Medical is a global regulatory consulting firm specializing in Middle East medical device registrations. Our services include:

• Regulatory strategy & pathway selection 
• Device classification & gap analysis 
• STED and dossier preparation 
• Local Authorized Representative coordination 
• End-to-end MOH submission and follow-up 
• Post-registration lifecycle management
  
  

Conclusion

Kuwait’s medical device and IVD regulatory framework is increasingly structured and aligned with international standards under MMPRRA. While this improves regulatory predictability, it also increases documentation, compliance, and post-market obligations for manufacturers.

Partnering with an experienced regulatory consultant like OMC Medical ensures faster approvals, reduced regulatory risk, and smooth long-term compliance in the Kuwait market. Whether you are entering Kuwait for the first time or expanding your product portfolio, a well-planned regulatory strategy is key to sustainable market access and uninterrupted supply.