Medical Devices Regulation in the Kingdom of Saudi Arabia (KSA)

The Saudi Food and Drug Authority (SFDA) regulates medical devices and IVDs sold and distributed in Saudi Arabia. A Medical Device Market Authorization (MDMA) from the SFDA is required to market medical devices (including IVDs) in the Kingdom of Saudi Arabia (KSA). The SFDA meticulously reviews MDMA applications, so prepare your submission carefully to ensure timely approval.

Medical Devices Regulation

• As KSA is an active member of AHWP, most Medical Devices regulations are based on IMDRF and GHTF requirements. These regulations ensure that only Medical Devices authorized by one of the founding IMDRF members have access to the Saudi Arabian market.
• The Saudi Arabian Food and Drug Authority (SFDA) was established in 2003 and is still constructing the regulatory infrastructure for Medical Devices registration. The SFDA operates through a Medical Devices Interim Regulations (MDIR) system. The SFDA is an independent authority that reports to the Council of Ministers and is responsible for the regulation of Medical Devices in Saudi Arabia.
• The MDIR is facilitated through a set of Electronic systems and solutions to enable manufacturers, Authorized Representatives, Importers, Distributors, and other parties to communicate efficiently with the SFDA. The electronic application forms are found on the Medical Devices Marketing Authorization (MDMA) portion of the SFDA’s website.

The Medical Devices interim regulation applies to the following parties and products:

1. Manufacturers, authorized representatives, importers and distributors.
2. All Medical Devices and their accessories that will be supplied to the KSA market.
3. Contact lenses and laser surgical equipment for cosmetic rather than medical purposes, and their accessories.

• Medical Devices may be placed on the market only if they comply with the applicable provisions of this MDIR. A local representative is required to handle the registration application on behalf of the foreign manufacturer.

SFDA Authorized Representative for medical device manufacturers

If you do not have an office or entity in Saudi Arabia, you must appoint a Saudi Arabia Authorized Representative. This representative needs to obtain an Authorized Representative License, which must be renewed annually, to legally represent you in the Kingdom of Saudi Arabia (KSA). Additionally, your KSA Authorized Representative is responsible for submitting all application documents to the Saudi Food and Drug Authority (SFDA) to register your device.

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Required Documentation

According to article 18 of MDIR, to register a Medical Devices, the applicant is asked to submit the following documentation to SFDA.

1. Application form;
2. Letter of Authorization (LOA);
3. Manufacturer and Saudi Authorization representative details;
4. GMP certificate or QM- system certificate (ISO 13485, ISO 9001);
5. Recent Audit Report;
6. Other Certificates as required by the Devices class;
7. Documents supporting the market authorization in reference IMDRF market;
8. Declaration of Conformity, written in English;

The declaration of conformity clearly identifies to which Medical Devices it applies and attests that the Medical Devices complies with the regulatory requirements of the relevant IMDRF Founding Member and also complies with the national provisions of MDIR.

• Environmental statements: Statement attesting that the Medical Devices complies with the regulatory requirements of the relevant IMDRF Founding Member jurisdiction and also complies with the national provisions of this Interim Regulation;
• The applicant shall indicate, which of the GHTF Founding Member(s) allows the Medical Devices that is the subject of the MDMA application, onto its market; and
• Regulatory Compliance Attestation: Statement confirming that the applicant will comply with the KSA’s National Centre for Medical Devices Reporting (NCMDR) requirement and any Filed Safety Corrective Action affecting the Medical Devices be reported to KSA authorities.

Moreover, the following Technical documents are requested for submission:

• A copy of the Medical Devices information including labeling, Intended use, instruction for use (IFU) and marketing materials, in English and/ or Arabic language;
• Specifications or similar documents that ensure, that the Medical Devices are correctly stored, transported, installed and maintained in the KSA, and users can be trained in their proper use;
• A report of any relevant adverse event, that involves the Medical Devices, be submitted to SFDA’s National Centre for Medical Devices Reporting (NCMDR).

Pre-Owned Medical Devices

Used or refurbished medical equipment is allowed entry into Saudi Arabia. However, the Ministry of Health and other Saudi government hospitals keep away from purchasing such equipment.

Post-Marketing Surveillance

The NCMDR receives reports of suspected Medical Device adverse events and confirmed product recalls from healthcare practitioners and device suppliers within the Kingdom of Saudi Arabia.

Saudi Arabian Medical Device Regulatory Process

The chart illustrates the SFDA approval process per device classification in the KSA and is available for download in the Regulatory Affairs Management Suite (RAMS). Only a condensed overview of the main steps for registration is provided here.

1. Step 1: Determine the classification of your device according to the SFDA’s classification rules.
2. Step 2: Appoint a KSA Authorized Representative (AR) to manage your device registration and interact with the SFDA on your behalf. Your KSA AR must present the authenticated AR contract to the SFDA for review and obtain a license to represent you in the KSA.
3. Step 3: Prepare the Technical File and application form for submission to the SFDA.
4. Step 4: Pay the application fee. The SFDA reviews the application and may request additional information.
5. Step 5: Upon SFDA approval, you will be issued a Medical Device Marketing Authorization (MDMA) certificate for your device.

SFDA Registration Requirements for Medical Devices

All application documents are submitted electronically via the SFDA’s Unified Electronic System or GHAD. SFDA submissions must be provided in English and include the following documentation:

Device information (including accessories)

• Trade name (in English and Arabic if the device is intended for lay use)
• Model name(s)/number(s), catalog number(s), etc. (for software, the major version number may be used for this purpose)
• Device description
• Intended purpose
• Classification
• Evidence of approval in other countries, if available

Labeling

• Labels and packaging; power supply label, where applicable
• Instructions for use (IFU) or justification letter, if not available
• Information on storage, transportation, installation, maintenance and disposal (may refer to IFU)
• Barcodes 
• Currently only required for lay-use devices

1. See the Unique Device Identification (UDI) section for information about the SFDA’s implementation of UDI requirements for all devices.

• Proposed advertising material
• For software, the SFDA generally requests an explanation of the version digits (e.g., which digit represents a significant/major change, and which digit indicates a minor change)

Design and Manufacturing Information

• Bill of materials
• Description of function and assembly of the device
• Technical specifications
• Manufacturing process flow

Essential principles checklist

Declaration of Conformity

Benefit-risk analysis and risk management

• Procedure
• Risk management plan
• Risk analysis
• Risk management report

Product verification and validation

• Pre-clinical data
• Clinical data

Post-market surveillance plan

Periodic Safety Update Report (or Post-market surveillance report for Class A medical devices/Class A and B IVDs)

The above is an abbreviated summary of information and documents that must be included in the Technical Documentation File submitted for MDMA registration for most devices.

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