How to Register a Medical Device in Saudi Arabia?

Written by Pharmadocx Consultants

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Medical Device

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30 May 2025

The Saudi Arabia medical device regulations are dynamic and are constantly being updated to protect patient health. We have prepared this detailed guide to help you easily register your medical device in Saudi Arabia.

Why should you choose Saudi Arabia for starting a medical device business?

Saudi Arabia is aiming to become a medical device manufacturing hub that will cater to not only the domestic demands but also be able to export to global markets. Saudi Arabia is the gateway to the Middle East and North African region as well as has close proximity to European and Asian regions. It offers a prime location for companies seeking to expand internationally. Hence, it is strategically located for starting a medical device business. Starting a medical device business in Saudi Arabia will open up global export opportunities. Notably, Saudi Arabia is prioritizing indigenous manufacturing in the medical device sector. Moreover, to encourage domestic medical device production, the government has introduced several schemes.

Saudi Arabia is an emerging market for medical device companies. The country is heavily invested in improving its healthcare infrastructure and patient care services. Additionally, it is focussed on strengthening its medical device industry. Thus, Saudi Arabia is a lucrative market for starting a medical device business. Saudi Arabia offers:

Government subsidies
Land and infrastructure support
Streamlined regulatory framework
Skilled workforce
Tax exemptions

Saudi Arabia is focusing on self-reliance in the medical device sector. Hence, the government has launched various schemes to boost local medical device production. Additionally, it is supporting infrastructural development in the medical device industry. Furthermore, it is fostering an environment conducive for research and development in the medical device sector. Hence, a medical device business in Saudi Arabia will have a promising future.

Regulations for medical device in Saudi Arabia

Saudi Arabia medical device classification system

To register a medical device in Saudi Arabia, it is important to understand the Saudi Arabia medical device classification system. The Saudi Food and Drug Administration (SFDA) has classified medical devices into four classes based on their risk level. Notably, grouping of medical device models, variants, accessories into a single application is permitted per SFDA medical device regulations. The SFDA medical device class is arranged in increasing order of risk levels.

Class A: Low risk medical devices. Class A has some sub categories. Low to medium risk sterile medical devices, measuring medical devices, and reusable surgical instruments form a part of Class A medical device subcategory.
Class B: Low to medium risk medical devices
Class C: Medium to high-risk medical devices
Class D: High risk medical devices

Registration pathways for medical device in Saudi Arabia

Compliance with SFDA guidelines is mandatory to register your medical device in Saudi Arabia. The Saudi Arabia medical device registration process and type depend on the SFDA medical device class. There are two primary SFDA medical device registration pathways:

Medical Device National Registry (MDNR) listing: For non-sterile/non-measuring low risk medical devices, listing in the Medical Device National Registry (MDNR) is required as a pre-requisite for selling the device in Saudi Arabia. This listing can be done by any establishment importing or distributing the device in the country. Basic product and manufacturer information, proof of QMS, and reference country approval are required. Additionally, device labelling and marketing materials are also required. The SFDA usually grants approval in 4 working days. Furthermore, this approval is valid for 3 years.
Medical Device Marketing Authorization (MDMA): For all other classes of devices, medical device approval issued as Medical Device Marketing Authorization (MDMA) is required to sell the device in Saudi Arabia. The SFDA medical device registration timeline for the MDMA approval is usually 35 days. Furthermore, the license will remain valid for the period of original license validity or 3 years for undefined original license validity.

Documents required for registering medical device in Saudi Arabia

Manufacturer and the Saudi authorized representative details.
Device information (including accessories): Trade name in English and Arabic (if the device is intended for lay use) and model name(s)/number(s), catalogue number(s), etc. have to be provided. Additionally, device description and intended purpose have to be mentioned. The medical device classification has to be mentioned. Evidence of approval in other countries, if available, may be provided.
Design and manufacturing information: Description of function, technical specifications, bill of materials, medical device design, and assembly of the device have to be provided. Additionally, manufacturing process flow has to be included.
Device label: Device labels, packaging, and power supply label, where applicable, have to be provided. Additionally, instructions for use (IFU) or justification letter, if not available, have to be included. Storage, transportation, installation, maintenance, and disposal information has to be mentioned. Furthermore, barcodes and proposed advertising materials have to be provided. Notably, all medical devices must be labelled in Arabic and English, including the essential safety and usage information.
Essential principles checklist
Benefit-risk analysis and risk management: Risk management plan, risk analysis, and risk management report have to be provided.
Product verification and validation: Pre-clinical data and clinical data have to be mentioned.
A statement certifying that the applicant will follow the National Centre of Medical Devices Reporting (NCMDR) requirements has to be provided.
Post-market surveillance plan
Periodic safety update report

We have provided an overview of the information to be included in the technical documentation file required for the Saudi Arabia medical device registration process. For a detailed list of documents required, feel free to reach out to us. Furthermore, we will help you prepare and compile the documents as per regulatory guidelines. Avail our comprehensive document preparation service to have your technical documents prepared in a hassle-free manner.

Saudi Arabia authorized representative

All foreign manufacturers not having a legal entity or physical presence in Saudi Arabia are required to appoint a medical device authorized representative. The authorized representative will act on behalf of the manufacturer in Saudi Arabia. Notably, the authorized representative must have an Authorized Representative License issued via the medical device establishment (MDEL) system. The authorized representative will be responsible for submitting the application to the SFDA to register your medical device. Additionally, the representative will act as a liaison between the SFDA and foreign manufacturer.