Overview of the Electronic Medical Devices in Saudi Arabia

Saudi Arabia’s electronic medical devices market is booming, driven by rising demand for advanced products, growing cancer cases, and increasing heart disease. The rapid adoption of smart wearables also adds to the electronic medical devices market, thanks to rising health awareness, remote healthcare needs, smartphone integration, and post-pandemic trends like work-from-home fitness tracking.

The electronic medical devices in Saudi Arabia reached SAR 8.1Bn in 2023 and is expected to grow at a Compound Annual Growth Rate (CAGR) of 5.9% amounting to SAR 10.8Bn by 2028.

The leading segment in the industry is electronic medical equipment and patient aids, followed by smart wearables.

Recent Developments
  • In 2023, Philips and Wipro have collaborated to provide an advanced electronic medical record (EMR) enterprise solution tailored for healthcare providers in Saudi Arabia.
  • In 2023, Digital Diagnostics, creator of FDA-cleared AI system IDx-DR, and UK health tech company, Open Medical Partners collaborate independently with Tamer Healthcare in Saudi Arabia to bring innovative digital transformation solutions to the region.
  • SFDA and UNDP extended their partnership until 2026 with a SAR 49.9Mn project to integrate biotechnology into pharmaceuticals, food, and medical devices, sharing regulatory expertise globally.
Challenges
  • For manufacturers, making sure their medical devices follow local rules, get registered and approved can be a complicated and time-consuming job.
  • Inequities in healthcare infrastructure and services between urban and rural areas result in uneven access to medical devices and healthcare services.
  • By the end of 2023, Saudi Arabia relied heavily on imports for approximately 90.0% of its medical device needs, primarily from the US and Europe, as local supply fell short. This has prompted the government to actively promote the entry of local manufacturers into the medical disposables market, in response to the challenges posed by the COVID-19 pandemic.
Market Segmentation

The electronic medical devices industry market is categorized into:

  • Electronic Medical Equipment and Patient Aids (97.8%): Monitoring devices, diagnostic devices, drug delivery devices, surgical devices, bio implants and stimulation devices, automation, and robotics. Patient aids include diabetes, hearing aids, neurostimulation, diagnostic instruments, cardio, orthopedics.
  • Smart Wearables (2.2%): Sensor-embedded wearable devices to monitor body vitals, such as body temperature, blood pressure, and heart rate
Regulatory Environment

The Saudi Food and Drug Authority (SFDA) oversees the regulation of medical devices available and distributed in Saudi Arabia. A Medical Device Market Authorization (MDMA) issued by the SFDA is mandatory for the marketing of medical devices within the Kingdom.

The SFDA develops and implements regulations and guidelines for the registration of medical devices, products, and related instruments. It aims to guarantee the safety, quality, and effectiveness of medical devices and products, including laboratory materials, medical eyewear, contact lenses, their solutions, and electronic products, while preventing any harmful effects on human health. It seeks to confirm the safety and precision of the calibration of medical and diagnostic devices.

 

Import-Export Analysis

In 2023, Import of Saudi Arabia’s electronic medical devices reached SAR 6.0Bn, up from SAR 4.5Bn in 2019, with a CAGR of 7.5% between 2019-2023. Saudi Arabia’s electronic medical device imports include hearing aid devices and instruments & appliances used in medical, surgical, dental, or veterinary sciences. In 2021, the US significantly contributed to the import of electronic medical devices and patient aids to Saudi Arabia while Mexico and Germany were the second and third largest suppliers. Also in 2021, Saudi Arabia sourced Hearing aid devices primarily from Australia followed by The US and Netherlands.

(Note: HS codes: 9018 and 902140 have been considered to generate above mentioned insights.)

Saudi Arabia’s electronic medical device exports include Hearing Aid devices and Instruments & appliances used in medical, surgical, dental, or veterinary sciences. Exports of Saudi electronic medical devices decreased from SAR 117.0Mn in 2019 to SAR 89.8Mn in 2023, with a CAGR of -6.4%. Saudi Arabia led electronic medical device exports to the Netherlands in 2021, likely influenced by a rising number of cancer cases. In 2021, UAE and Germany were the second and third largest trading partners for Saudi Arabia in electronic medical devices. Also in 2021, Saudi Arabia primarily directed its exports of Hearing Aids to South Africa and the UAE.

(Note: HS codes: 9018 and 902140 have been considered to generate above mentioned insights.)
Local Manufacturing in the Electronics Medical Devices

In 2023, local manufacturing within the electronic medical devices in Saudi Arabia was estimated to be around 27.1% of the overall electronics market. The favorable geographic location, supportive government policies, and a sizable domestic market collectively establish an environment conducive to medical device manufacturing in the KSA.

 

Competitive Landscape

The Saudi Arabia’s Electronic Medical Devices market is primarily dominated by global specialized players

Baxter International: Established in 1931 with an annual revenue of SAR 56.6Bn (2023). Baxter impacts millions worldwide daily, with its products and therapies prevalent across various healthcare settings, spanning hospitals, clinics, and homes. In 2009, The Olayan Group and Baxter Healthcare established a joint venture known as Baxter Company Limited (BCL) to get Baxter into the Saudi Arabian market. Their products include Infusion Systems and Specialized Patient Monitoring, IV Preparation and Compounding, Acute Renal Therapy, Hemodialysis, Peritoneal Dialysis.

Boston Scientific Corporation: Incorporated in 1978, Boston Scientific Corporation has an annual revenue of SAR 48.8Bn (2023). The company creates and distributes medical devices across three segments: Rhythm and Neuro, Cardiovascular, and MedSurg. Rhythm and Neuro focuses on heart monitoring and therapy, Cardiovascular develops technologies for heart diseases, and MedSurg offers minimally invasive devices for gastrointestinal and pulmonary conditions. In 2021, Boston Scientific established a direct presence in Saudi Arabia after a long history of operating through indirect channel partners. The company’s products include Access Devices, Diagnostics, Mapping and Navigation Equipment, Ablation Systems, Ultrasound Imaging Systems, Electrophysiology Recording Systems, CO2 Laser Systems, Deep Brain Stimulation Systems, Defibrillators, Direct Visualization Systems, and Thrombectomy Systems.

Medtronic: Founded in 1949, Medtronic has an annual revenue of SAR 117.1Bn (2023). The company pioneer’s revolutionary healthcare technology solutions, addressing the most intricate and demanding conditions worldwide. In 2013, Medtronic identified Saudi Arabia as a key to its success due to the significant and tangible opportunities within the market. This led to the landmark development of Medtronic Saudi Arabia in 2015. Medtronic’s product range includes Electrosurgical Hardware, Pacemakers, Hemostasis Management Systems, Oxygenators, Monitoring Systems, Integrated Power Console (IPC) Systems, Parathyroid Detection Systems, Oximeters, Ventilators, and Visualization Solutions.

Fresenius Medical Care Ag & Co: Instituted in 1996, Fresenius Medical Care boasts an annual revenue of SAR 160.1Bn (2023). The company provides a comprehensive range of products and services covering the entire dialysis value chain from a unified source. Operating a global network of over 4,000 dialysis clinics serving approximately 345,000 patients, Fresenius Medical Care is supported by 42 production sites across all continents. These facilities supply essential dialysis products, including machines, dialyzers, and related disposables. In 2022, Fresenius Medical Care established their first nephrocare clinic in Saudi Arabia, located in the center of Riyadh. Their product portfolio includes Peritoneal Dialysis Machines, Home Hemodialysis Machines, Acute Dialysis Machines, and Dialyzers.

General Electric Healthcare: Initiated in 1892, GE HealthCare achieves an annual revenue of SAR 68.6Bn (2023). As a leading innovator in global medical technology and digital solutions, GE HealthCare empowers clinicians with intelligent devices, data analytics, applications, and services through its Edison intelligence platform. GE HealthCare has maintained a presence in Saudi Arabia since the 1980s, offering a diverse range of products including Imaging systems, Ultrasound machines, Diagnostic ECG equipment, and Ventilators.

Apple: Organized in 1976, Apple, Inc. reported an annual revenue of SAR 1,444.3Bn in 2023. Headquartered in Cupertino, California, Apple operates across the Americas, Europe, Greater China, Japan, and the rest of Asia Pacific. Apple uses third parties to sell its products in Saudi Arabia. Their product lineup includes Watches, among other innovations.

Huawei Technologies: Formed in 1987, Huawei anticipates an annual revenue of SAR 369.4Bn in 2023. As a global technology leader headquartered in Shenzhen, China, Huawei specializes in connecting the world through information and communications technology (ICT). Since 2002, Huawei has maintained a presence in Saudi Arabia, providing a wide range of innovative products and services. Their product lineup includes Classic watches, Smart technology watches, and band series.

Fitbit: Founded in 2007, Fitbit, now a part of Google, reported an annual revenue of SAR 4.35Bn in 2022. The company is driven by a dedicated team passionate about health and fitness, creating products designed to improve lives. Their product range includes Watches.

 

 

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