Romania Medical Devices Market (2025-2031) | Outlook, Analysis, Companies, Trends, Size, Forecast, Share, Value, Industry, Revenue & Growth

Romania Medical Devices market Highlights

Report Name	Romania Medical Devices market
Forecast period	2025-2031
Market Size	USD 1.3 Billion –  USD 2.9 Billion
CAGR	6.8%
Growing Sector	Healthcare

Topics Covered in the Romania Medical Devices Market Report

The Romania Medical Devices market report thoroughly covers the market by type and by application. The report provides an unbiased and detailed analysis of the on-going market trends, opportunities/high growth areas, and market drivers which would help the stakeholders to devise and align their market strategies according to the current and future market dynamics.

Romania Medical Devices Market Size & Analysis

In 2025, the Romania Medical Devices market is valued at approximately $ 1.3 billion, with a projected compound annual growth rate (CAGR) of 6.8% over the next five years. Additionally, by 2031, the market is expected to reach around $ 2.9 billion. The healthcare sector holds significant position in the overall market.

Romania Medical Devices Market Synopsis

The Romania medical devices market is experiencing steady growth, fueled by an expanding healthcare sector, rising demand for advanced medical technologies, and increasing government investments in healthcare infrastructure. With a growing population and a heightened focus on improving patient care, Romania is seeing greater adoption of diagnostic imaging, surgical instruments, and patient monitoring devices. Chronic disease prevalence, coupled with an aging population, is also driving demand for specialized medical devices and equipment. While the market is dominated by imported products from global companies, the local manufacturing sector is gradually developing, focusing on cost-effective solutions for both public and private healthcare providers. As Romania continues to modernize its healthcare services, the medical devices market is expected to grow, offering opportunities for international and domestic players alike.

According to 6Wresearch, Romania Medical Devices market size is projected to grow at a CAGR of 6.8% during 2025-2031. The growth of Romania's medical devices market is fueled by several key drivers, including rising healthcare spending, government initiatives to modernize healthcare infrastructure, and an aging population with increasing healthcare needs. The prevalence of chronic diseases, such as cardiovascular and respiratory illnesses, has heightened demand for diagnostic and monitoring devices, while the expansion of private healthcare services is boosting the adoption of advanced technologies like imaging and minimally invasive surgical equipment.

Additionally, Romania's alignment with European Union (EU) standards has improved regulatory processes, facilitating market entry for global players. However, the Romania Medical Devices industry faces challenges such as heavy reliance on imported devices, which can drive up costs and impact accessibility, particularly in public healthcare. Limited local production capacity, high regulatory compliance costs, and regional disparities in healthcare infrastructure also pose obstacles to market growth. Addressing these challenges through increased investment in local manufacturing and regulatory alignment could further accelerate Romania’s medical devices sector.

Romania Medical Devices Market Trends

Growth in Digital Health Technologies - Increasing adoption of telemedicine, remote patient monitoring, and AI-driven diagnostics to improve healthcare accessibility and efficiency.

Rising Demand for Diagnostic and Imaging Equipment - Enhanced focus on early diagnosis of chronic diseases is driving demand for MRI, CT, and ultrasound devices.

Shift Towards Minimally Invasive Procedures - Greater preference for minimally invasive surgeries is boosting the demand for advanced surgical tools and endoscopy devices.

Expansion of Private Healthcare Sector - Growth in private healthcare facilities is increasing investments in high-end medical devices and improving access to modern treatment options.

Increased Adoption of Point-of-Care Testing - High demand for rapid, on-site testing solutions, especially in rural and underserved regions, is fostering the use of point-of-care diagnostic devices.

Investment Opportunities in the Romania Medical Devices Market

Diagnostic Imaging Equipment - High demand for advanced MRI, CT, and ultrasound machines, particularly as healthcare facilities modernize to meet rising diagnostic needs.

Telemedicine and Remote Monitoring - Expanding telemedicine services present opportunities for investment in digital health platforms and remote monitoring devices.

Point-of-Care Testing Devices - Increasing demand in rural areas and smaller healthcare facilities creates potential for investment in portable and rapid diagnostic devices.

Minimally Invasive Surgical Equipment - Rising preference for minimally invasive procedures supports investment in endoscopic devices, laparoscopic tools, and robotic surgery systems.

Home Healthcare Devices - Growing aging population and prevalence of chronic diseases drive demand for home-use devices like glucose monitors, respiratory devices, and blood pressure monitors.

Local Manufacturing Capacity - Opportunity to establish or expand domestic production of medical devices, reducing dependency on imports and improving cost-effectiveness.

Healthcare Infrastructure Development - Government and private sector investments in new hospitals and clinics open up opportunities for supplying essential and high-tech medical equipment.

Key Players in the Romania Medical Devices Market

The Romania medical devices market is characterized by a mix of international giants and emerging domestic players. Key global companies include Siemens Healthineers, GE Healthcare, Philips Healthcare, and Medtronic, which dominate in advanced imaging, diagnostic, and therapeutic equipment. Johnson & Johnson and B. Braun are also prominent, providing a wide range of surgical instruments and hospital supplies. Domestic companies, such as Medicarom Group and Tehno Electro Medical Company (TEMCO), focus primarily on distribution and some production of basic medical equipment, helping bridge supply needs in the local market.

Additionally, some of these players hold majority of the Romania Medical Devices market share. Moreover, these companies leverage Romania’s strategic position in the EU to import and distribute high-quality devices, supporting the country's growing demand for modern healthcare solutions.

Government Regulations in the Romania Medical Devices Market

Romania medical devices market operates under stringent regulations aligned with the European Union Medical Device Regulation (EU MDR) and in Vitro Diagnostic Regulation (IVDR), which aim to ensure high standards of safety, efficacy, and transparency. These EU regulations require that all devices sold in Romania meet strict quality and documentation standards, undergo regular safety evaluations, and obtain CE marking before market entry.

The National Agency for Medicines and Medical Devices (NAMMD) oversees the registration, monitoring, and compliance of medical devices, working to ensure that only approved and safe products are available. Further, these initiatives have further boosted the Romania Medical Devices market revenues. Furthermore, regulations are in place for clinical investigations, advertising practices, and post-market surveillance to safeguard patient safety. While these standards support product quality and trust, they also pose challenges for local and smaller companies due to the rigorous and costly compliance requirements.

Future Insights of the Romania Medical Devices Market

The Romania medical devices market is expected to experience steady growth, driven by increasing healthcare investments, technological advancements, and a rising demand for high-quality healthcare services. As the country continues to modernize its healthcare infrastructure, there will likely be an expansion in advanced medical equipment, including diagnostic imaging, minimally invasive surgical devices, and patient monitoring systems.

Digital health and telemedicine are also anticipated to gain momentum, especially with Romania’s growing commitment to improving healthcare accessibility in both urban and rural areas. Additionally, the shift toward preventive healthcare, alongside EU-aligned regulatory standards, will further support the adoption of innovative devices, creating opportunities for both domestic and international players.

Diagnostic Devices Category to Dominate the Market - By Type

According to Ravi Bhandari, Research Head, 6Wresearch, the diagnostic devices category in Romania is experiencing notable growth, driven by an increased focus on early disease detection and the rising prevalence of chronic conditions such as cardiovascular diseases, diabetes, and cancer. Demand for advanced diagnostic imaging technologies, including MRI, CT scans, and ultrasound machines, is surging as healthcare facilities prioritize timely and accurate diagnosis.

Point-of-care testing devices are also gaining traction, especially in rural and underserved areas, where immediate access to diagnostic results is critical. Additionally, government initiatives and healthcare reforms aiming to modernize Romania’s healthcare infrastructure are contributing to investments in diagnostic equipment. As a result, this category is expected to grow steadily, meeting both clinical and outpatient diagnostic needs across the country.

Hospitals & Ambulatory Surgical Centers to Dominate the Market – By Application

Growth in the hospitals and ambulatory surgical centers (ASCs) segment in Romania’s medical devices market is fueled by rising investments in healthcare infrastructure and the expansion of private healthcare facilities. Hospitals are increasingly adopting advanced medical technologies, such as minimally invasive surgical devices, robotic systems, and patient monitoring equipment, to enhance treatment efficiency and outcomes. Ambulatory surgical centers, which provide cost-effective and convenient alternatives for procedures that do not require hospitalization, are also experiencing strong demand, particularly for diagnostic and outpatient surgical procedures.

The growing preference for ASCs is driven by shorter recovery times, lower costs, and increased patient satisfaction. Together, hospitals and ASCs are poised to become significant contributors to the medical device market's growth, as both sectors strive to improve accessibility and quality of care across Romania.

Key Attractiveness of the Report

• 10 Years Market Numbers.
• Historical Data Starting from 2021 to 2024.
• Base Year - 2024.
• Forecast Data until 2031.
• Key Performance Indicators Impacting the Market.
• Major Upcoming Developments and Projects.

Key Highlights of the Report:

• Romania Medical Devices Market Outlook
• Market Size of Romania Medical Devices Market, 2024
• Forecast of Romania Medical Devices Market, 2031
• Historical Data and Forecast of Romania Medical Devices Revenues & Volume for the Period 2021-2031
• Romania Medical Devices Market Trend Evolution
• Romania Medical Devices Market Drivers and Challenges
• Romania Medical Devices Price Trends
• Romania Medical Devices Porter's Five Forces
• Romania Medical Devices Industry Life Cycle
• Historical Data and Forecast of Romania Medical Devices Market Revenues & Volume By Types for the Period 2021-2031
• Historical Data and Forecast of Romania Medical Devices Market Revenues & Volume By Orthopedic Devices for the Period 2021-2031
• Historical Data and Forecast of Romania Medical Devices Market Revenues & Volume By Cardiovascular Devices for the Period 2021-2031
• Historical Data and Forecast of Romania Medical Devices Market Revenues & Volume By Diagnostic Devices for the Period 2021-2031
• Historical Data and Forecast of Romania Medical Devices Market Revenues & Volume By IVD for the Period 2021-2031
• Historical Data and Forecast of Romania Medical Devices Market Revenues & Volume By MIS for the Period 2021-2031
• Historical Data and Forecast of Romania Medical Devices Market Revenues & Volume By Wound Management for the Period 2021-2031
• Historical Data and Forecast of Romania Medical Devices Market Revenues & Volume By Diabetes Care for the Period 2021-2031
• Historical Data and Forecast of Romania Orthopedic Devices Medical Devices Market Revenues & Volume By Others for the Period 2021-2031
• Historical Data and Forecast of Romania Medical Devices Market Revenues & Volume By Applications for the Period 2021-2031
• Historical Data and Forecast of Romania Medical Devices Market Revenues & Volume By Hospitals & Ambulatory Surgical Centers for the Period 2021-2031
• Historical Data and Forecast of Romania Medical Devices Market Revenues & Volume By Clinics for the Period 2021-2031
• Historical Data and Forecast of Romania Medical Devices Market Revenues & Volume By Others for the Period 2021-2031
• Romania Medical Devices Import Export Trade Statistics
• Market Opportunity Assessment By Types
• Market Opportunity Assessment By Applications
• Romania Medical Devices Top Companies Market Share
• Romania Medical Devices Competitive Benchmarking By Technical and Operational Parameters
• Romania Medical Devices Company Profiles
• Romania Medical Devices Key Strategic Recommendations

Market Covered

The report offers a comprehensive study of the subsequent market segments:

By Types

• Orthopedic Devices
• Cardiovascular Devices
• Diagnostic Devices
• IVD
• MIS
• Wound Management
• Diabetes Care
• Others

By Applications

• Hospitals & Ambulatory Surgical Centers
• Clinics
• Others