GCC Medical Device Registration: Qatar, Kuwait, Bahrain & Oman Complete Guide

Why the Smaller GCC States Matter

Saudi Arabia and the UAE dominate the medical device market conversation in the Gulf, but the four smaller GCC states — Qatar, Kuwait, Bahrain, and Oman — collectively represent a significant and growing opportunity. Combined healthcare spending across these markets has grown steadily, driven by government investment in healthcare infrastructure, rising chronic disease prevalence, and ambitious national health strategies.

Each of these countries maintains its own regulatory system with distinct requirements, timelines, and processes. Unlike the EU, there is no single centralized medical device registration that covers all GCC states. The Gulf Health Council (GHC) offers a centralized pharmaceutical registration procedure, but for medical devices, each country requires separate national registration — though having approvals from reference markets (Saudi SFDA, US FDA, EU CE marking) significantly streamlines the process.

This guide covers the complete registration requirements for each country, current as of April 2026.

Country-by-Country Registration Requirements

Kuwait: Ministerial Decree 387/2025 Framework

Regulatory Authority

Medical devices and IVDs in Kuwait are regulated by the Ministry of Health (MOH) through the Medicine and Medical Products Registration and Regulatory Administration (MMPRRA). The regulatory framework underwent a significant update with the issuance of Ministerial Decree No. 387 of 2025, which established comprehensive requirements for the registration and circulation of medical devices and IVDs in Kuwait.

Classification System

Kuwait uses a risk-based classification system aligned with IMDRF principles under MD 387/2025:

Class	Risk Level	Description
Class A	Low	Non-invasive devices, minimal patient contact
Class B	Low–Moderate	Short-term invasive devices, low-to-moderate risk
Class C	Moderate–High	Medium-term invasive devices, moderate-to-high risk
Class D	High	Long-term implants, life-sustaining devices
IVD Class A–D	Low to High	Separate IVD classification aligned with IMDRF

Registration Pathways

Under MD 387/2025, Kuwait offers three registration pathways:

1. Standard Pathway: Full technical dossier submission with complete documentation review. Required for devices not eligible for reliance or expedited review. Timeline: 6–8 months.

2. Fast-Track Pathway: Available for devices addressing urgent healthcare needs, such as supply contracts or requests from the Central Medical Stores (CMS). The authority exercises discretion in granting fast-track status. Timeline: 3–5 months.

3. Abridged (Reliance) Pathway: Leverages existing marketing authorizations from recognized reference regulators (FDA, CE marking under EU MDR, MHRA, Health Canada, TGA, PMDA, ANVISA, SFDA) to reduce duplication and expedite review. This pathway uses STED-format documentation aligned with IMDRF requirements. Timeline: 2–4 months.

Required Documentation

• Completed registration application form
• Authorization letter to the Kuwaiti Authorized Representative (AR), legalized
• ISO 13485 certificate of the manufacturer
• Certificate of Free Sale from the country of origin
• CE certificate or FDA clearance (mandatory for fast-track; recommended for standard)
• Technical file in STED or EU MDR format
• Labeling and IFU (Arabic and English)
• Clinical evaluation report
• Risk management file (ISO 14971)
• Pharmacovigilance commitment letter
• Product samples (upon request)

Fees and Timeline

Item	Details
Application fee	Varies by pathway; contact MMPRRA
Registration validity	3–5 years (device-dependent)
Review timeline	2–8 months depending on pathway
Authorized Representative	Required for all foreign manufacturers

Key Considerations

• Kuwait established a structured framework for the withdrawal or suspension of medical devices that exhibit defects or health risks
• The decree requires all medical devices and IVDs to be registered with the MOH before importation, marketing, or distribution in both public and private sectors
• Kuwait recognizes the Gulf Health Council's centralized procedure for pharmaceuticals, but medical device registration remains a national process

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Bahrain: NHRA Mandatory Registration

Regulatory Authority

The National Health Regulatory Authority (NHRA) of Bahrain is responsible for medical device regulation. Under Resolution No. 48 of 2020, all medical devices must be registered with the NHRA before they can be imported, marketed, or used in the Kingdom of Bahrain. The mandatory registration deadline was February 1, 2026.

Classification System

Bahrain uses a three-class system for medical devices aligned with EU standards:

Class	Risk Level	Registration Requirement
Class I	Low	Optional registration; listing recommended
Class IIa/IIb	Moderate	Mandatory registration
Class III	High	Mandatory registration
IVD Class B/C/D	Moderate–High	Mandatory registration

Note: While Class I registration is technically optional, the NHRA strongly recommends listing all devices. All medium and high-risk devices (Class IIa, IIb, III and IVD Class B, C, D) must be registered.

Registration Process

1. Appoint a Registered Authorized Representative (AR): Only ARs registered with NHRA can submit device registration applications. The AR must hold a valid Commercial Registration with medical device activity.

2. List devices with NHRA: Before submitting registration applications, the AR must list all devices by submitting a listing form to medical_devices@nhra.bh.

3. Book an appointment on the Ajheza system: Registration is done through NHRA's Ajheza system. The AR books an appointment and submits all required documents at the booked date and time.

4. Submit required documentation:

   • Medical Device Registration form (Annex 1), signed and stamped by AR
   • Technical details: user manual, catalogue, service manual
   • Artwork/label (must include device identification number and manufacturer details)
   • Authorization letter or agreement from legal manufacturer to AR
   • ISO 13485 certificate
   • Certificate of Free Sale
   • Declaration of Conformity (per EU regulations)
   • EC Design Examination Certificate or FDA CFG (required for Class III and IVD Class D)
   • Quality Assurance Certificate (QAC) with verification evidence
   • GMDN code

5. NHRA review and approval: Review takes 20 working days (standard) or 10 working days (fast-track via recognized conformity assessment body). Certificate validity is 1 year, renewable with updated documentation.

Fast-Track Option

NHRA has recognized ABC Company as a conformity assessment body for fast-track application submissions. Manufacturers using this recognized body benefit from accelerated review.

Fees

Fees are applied and notice to pay is sent through the Ajheza system. Exact fee amounts are communicated during the application process and vary by device classification.

Importation Requirements

Importation of medical devices (Class II and III) must go through the OFOQ system (Bahrain's online import portal). Key rules:

• Importation must be done through an authorized representative of the legal manufacturer
• Importers must have Commercial Registration with activity code 4659 (Medical Devices supplies and Related Parts)
• Healthcare facilities, importers, clearance agents, and regulatory affairs professionals can apply on OFOQ
• All documents must be uploaded individually in PDF format, in Arabic or English

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Oman: MOH Class C & D Registration Portal

Regulatory Authority

Oman's Ministry of Health (MOH) regulates medical devices through its Drug Safety Center / Medical Device Committee. In a significant regulatory development, Oman officially launched the registration process for Class C and Class D (high-risk) medical devices in July 2025 under Circular 161/2025.

Classification System

Oman uses the following risk-based classification:

Oman Classification	Risk Level	GHTF Equivalent
Class A/B	Low	Class I/II
Class C	Moderate–High	Class III equivalent
Class D	High	Class IV equivalent
IVD	Classified separately	A–D system

Low-risk devices (Class A/B/Class I): Not currently subject to mandatory registration, though listing is recommended.

Moderate-to-high risk (Class C/Class II) and High risk (Class D/Class III): Mandatory registration under the new framework. Registration became mandatory before July 1, 2026 — importation without registration is now restricted.

Registration Process

The MOH launched its e-portal for device applications on August 11, 2025. The registration process requires:

Section 1: Application Type

• Medical device or IVD designation
• Device name, risk classification, device grouping
• Regulatory jurisdiction the device follows (options: KSA MDMA, USA, EU, Canada, Australia, Japan, or Others)

Section 2: Manufacturer Information

• Manufacturer name, physical site address
• Quality management system certificates (e.g., ISO 13485)

Section 3: Device Information

• Full device description, intended use, indications
• Device identifier, batch/lot reference numbers
• Label, catalogue, IFU

Section 4: Device Labeling

• Instructions for Use (IFU)
• Device label
• Product labels and packaging
• Promotional materials/catalogue

Section 5: Essential Principles & Conformity Evidence

• Essential Principles checklist demonstrating safety and performance
• Evidence of conformity with recognized standards

Reference Market Recognition

Oman explicitly recognizes approvals from the following jurisdictions for the purposes of registration:

• Saudi Arabia (SFDA MDMA)
• United States (FDA)
• European Union (CE marking)
• Canada (Health Canada)
• Australia (TGA)
• Japan (PMDA)

Having approval from one of these reference markets significantly streamlines the registration process in Oman, as the MOH can leverage the reference authority's assessment.

Fees and Timeline

Item	Details
Review timeline	10–20 working days
Certificate validity	1 year initially; must be renewed with updated documentation
Fees	Applied through the e-portal

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Qatar: MOPH Pharmacy and Drug Control Department

Regulatory Authority

Medical devices in Qatar are regulated by the Ministry of Public Health (MoPH), specifically through the Pharmacy and Drug Control Department (PDCD). Qatar's regulatory framework differentiates between implantable and non-implantable devices.

Registration Pathways

Qatar operates two distinct pathways based on device type:

Device Category	Regulatory Requirement	Key Characteristics
Implantable devices	Full Registration	Mandatory pre-market registration with MoPH before any import or sale
Non-implantable devices & consumables	Import Permit (per shipment)	Required prior to each shipment — the standard route for most medical devices

Reference Market Approval Requirement

For both pathways, a fundamental prerequisite is that the device must hold prior authorization from a reference market regulator recognized by the GHTF:

• USA (FDA 510(k) or PMA)
• European Union (CE Marking under EU MDR/IVDR)
• Japan (PMDA)
• Canada (Health Canada)
• Australia (TGA)

This reference market approval forms the basis for the technical review in Qatar.

Required Documentation (Import Permit — Non-Implantable Devices)

The local AR must submit the following for each import permit application:

1. Certificate of Free Sale (CFS): Issued by the health authority in the country of manufacture, legalized by the Qatari Embassy/Consulate
2. Commercial Invoice & Packing List: Specific to the intended shipment
3. Certificate of Origin: For customs clearance
4. Technical Dossier: Including:
   • ISO 13485 certificate of the manufacturing facility
   • Product description and specifications
   • Labels and IFU
   • Risk analysis
   • Clinical evaluation data (for higher-risk devices)

Required Documentation (Full Registration — Implantable Devices)

For implantable devices requiring full registration:

• Complete technical file (STED or EU MDR format)
• CE certificate or FDA approval
• Clinical data and clinical evaluation report
• Post-market surveillance plan
• ISO 13485 certificate
• Declaration of Conformity
• Arabic and English labeling

Fees and Timeline

Item	Details
Import permit	Per shipment; processing typically 1–2 weeks
Full registration	Device-specific; timeline varies by risk class
Authorized Representative	Required for all foreign manufacturers
Registration validity	Varies; typically 3–5 years

Gulf Health Council Harmonization

The Gulf Health Council (GHC), formerly the Gulf Cooperation Council Health Ministers' Council, offers a centralized pharmaceutical registration procedure that covers all six GCC member states. However, there are important limitations for medical devices:

• Pharmaceuticals: The centralized procedure allows a single application to the GCC Drug Regulation (GCC-DR) for review by a panel of experts from different GCC countries. If approved, the GCC Health Council issues a registration certificate accepted across member states, though some national-level steps (pricing approvals, import licenses) may still be required.

• Medical Devices: There is no equivalent centralized procedure for medical devices at this time. Each GCC country requires separate national registration. However, having approvals from reference markets — particularly Saudi SFDA MDMA — is increasingly recognized across the GCC and can streamline individual country applications.

The GHC continues to work toward greater harmonization of medical device regulations across the region, and manufacturers should monitor developments that could eventually lead to a more unified GCC device registration process.

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Cross-Country Comparison Matrix

Requirement	Kuwait	Bahrain	Oman	Qatar
Regulatory Authority	MOH / MMPRRA	NHRA	MOH	MoPH / PDCD
Governing Regulation	MD 387/2025	Resolution 48/2020	Circular 161/2025	MoPH regulations
Classification System	IMDRF A–D	EU-aligned I–III	GHTF A–D	GHTF-aligned
Mandatory Registration	All classes	Class II+ / IVD B+	Class C & D	Implantables; permits for others
AR Required	Yes	Yes (registered with NHRA)	Yes	Yes
Reference Market Recognition	Yes (SFDA, FDA, CE, etc.)	Yes (SFDA, FDA, MHRA, TGA)	Yes (SFDA, FDA, EU, etc.)	Yes (FDA, CE, PMDA, etc.)
Submission System	MOH portal	Ajheza system	MOH e-portal	MoPH portal
Review Timeline	2–8 months	20 working days (standard)	10–20 working days	1–2 weeks (permits)
Certificate Validity	3–5 years	1 year	1 year	3–5 years
Arabic Labeling	Required	Required	Required	Required
ISO 13485	Required	Required	Required	Required

Practical Recommendations

1. Register in Saudi Arabia first. The SFDA MDMA is the most recognized and established regulatory framework in the GCC. Having Saudi approval significantly accelerates registration in Kuwait, Bahrain, Oman, and Qatar — all of which explicitly reference SFDA approval as a recognized basis for streamlined review.

2. Plan for parallel submissions. Since there is no centralized GCC device registration, manufacturers pursuing multiple GCC markets should prepare country-specific dossiers in parallel to minimize time-to-market across the region.

3. Appoint experienced local representatives. The quality of your local AR directly impacts registration timelines. Choose representatives with established relationships with the relevant regulatory authorities and a track record in your device category.

4. Budget for legalization costs. Certificates of Free Sale and authorization letters typically require legalization by the embassy/consulate of each target country — a process that adds both time and cost.

5. Start Arabic translation early. All four countries require Arabic labeling and IFU. Begin translation and artwork preparation before starting the registration process.

6. Monitor regulatory evolution. All four markets are actively developing their regulatory frameworks. Kuwait's MD 387/2025, Bahrain's mandatory registration deadline, Oman's new e-portal, and Qatar's evolving requirements all represent relatively recent changes. Engage with local regulatory consultants who track these developments in real time.