Medical Devices
Overview

KSA is well-positioned to grow its medical devices and consumables sector to serve local and regional demand by leveraging existing ecosystem and proximity to MENA and Europe. Medical device industry is an attractive sector in Saudi Arabia for several key reasons:

  • The domestic market is large (i.e., ~SAR 20B) and growing (~5% p.a.), with significant import substitution potential (94% of local demand is imported)
  • Export potential to countries in MENA and Europe due to proximity and free trade agreements supported by export enablement package: including new export financing solutions such as EXIM bank and streamlined export procedures.
  • Leverage the value chains in Saudi Arabia – e.g. plastics – and can provide a supporting ecosystem to develop medical devices industry.
  • Tailored incentives for strategic projects and general incentives package for local manufacturers e.g. 10% preferential price, human capital development and Governmental Support for industry 4.0 …etc
  • Access to +40 industrial cities across the kingdom, with upgraded infrastructure and equipment. Additionally, the Saudi ports network consists of 9 ports, 3 of them are industrial ports equipped with the latest necessary technologies and operational methods to welcome all types of maritime shipping modes.

The significant change in demographics profoundly affects the future shape and direction of the Saudi healthcare system. The Population is expected to reach 39M in 2030. Additionally, Doyof Al Rahman Program (DARP), one of Saudi Arabia’s Vision 2030 realization programs whose mission is to comprehensively improve the Pilgrims’ experience, and to achieve the target of 30 million Pilgrims visiting annually by 2030 mandates agile healthcare settings and services. Thus, there are huge opportunities which stem out of the need to provide fast response time for emergency situations by continually monitoring every single pilgrim’s vital sign, screening and identifying communicable diseases. 

Additionally, the Saudi medical devices market is the biggest in the MENA region, well-regulated and has a stable demand through the concentrated buyers (NUPCO and GULF HEALTH COUNCIL). However, the private sector is improving and outpacing public sector growth. The number of private hospitals and beds has grown by %2.9 and %3 respectively over the last 5 years. This goes in alignment with the realization of 2030 vision which seeks to foster the private sector participation to play a pivotal role in transforming the healthcare sector. This will ultimately impact the financial performance of the private sector which will enhance payments for Medical device companies.

  

Currently, there are more than 45 local medical device manufacturers with a market share of ~6% (SAR 1.2B).  By 2025, the target is to increase the number to 16% by expanding the current product portfolio and attraction of new medical device technologies to provide comprehensive solutions needed by the healthcare providers which should ultimately reflect on the diversity of products and the number of factories to be established within this period.  Products manufactured in the kingdom fall into different categories 40% of them are single-use devices made out of plastic. Other products being manufactured are reusable surgical instruments, detergents and solutions, general IVD, hospital furniture, dental and ophthalmic products. The manufacturer of glocumneters and strips are currently under construction which is expected to cover the local and regional market.

The current opportunities in the industry arise from healthcare sector growth and the government support to substitute the import. This new strategy will capitalize on the local value chain and move forward to value-added MedTech devices driven by local and regional demand. Some of the opportunities the IC have identified are; Infusion and Syringe pump and their consumables, Insulin Pump, Patient monitoring devices, Blood collection bags, Advanced Wound Management, Otoscope and ophthalmoscopes, Sphygmomanometers (electronic and aneroid), Thermometers (oral and tympanic), Bone Fixation and orthopaedic, Laboratory devices and reagents for primary healthcare, Ultrasound imaging devices.

 

The government’s endeavours to expand healthcare services to match the international standard will maintain the growth on demand for medical devices, the current patient per bed is 2.5 while the targeted ratio is 3.7. Furthermore, the investment in expanding primary healthcare centres and focus on home healthcare services will reflect on demand for home healthcare technologies and telemedicine services and technologies. Under 2030 vision public sector will invest in promoting preventive care, reducing infectious diseases and encouraging citizens to make use of primary care as the patient's first point of entry into the health care system and the focal point for all needed health care services.

 

The market of Medical Devices is regulated by the Saudi Food and Drug Authority (SFDA) with reliance on scientific evidence and risk assessment through collaboration with domain expert to effectively monitor and control different components of the value chain across the life cycle of medical devices. The EU, US FDA and Japanese approvals are recognized in Saudi Ariba making it easy for international manufacturers to capitalize on their strength in the regulatory field without the need to change the structure of the technical documentation to serve to the regional market. Moreover, the SFDA is an active participant in the International standardization committees and chairmen of regional working parties to unify Medical Device Regulation. The SFDA approval is recognized in Gulf Council Countries and most of the African market.