Executive Summary
Market Entry
Current Market Trends
Best Prospects
Market Size
Main Competitors
Current Demand
Registration Process
Reimbursement
Barriers
Procurement & Tenders
Trade Events
Frequently Asked Questions
U.S. Commercial Service Contact Information
Tab Options
Executive Summary
Market Entry
Current Market Trends
Best Prospects
Market Size
Main Competitors
Current Demand
Registration Process
Reimbursement
Barriers
Procurement & Tenders
Trade Events
Frequently Asked Questions
U.S. Commercial Service Contact Information
Executive Summary
In 2019, healthcare expenditures in Finland amounted to 9.2 percent of GDP ($25.12 billion USD). The biggest growth was in outpatient care medicine (+10.1 percent), primary care (+4.5 percent) and in long-term and homecare for the elderly and disabled (+4.2 percent). Universal health insurance coverage is accessible for all citizens and permanent residents in the country, with a range of comprehensive health services delivered primarily by publicly owned and operated providers. In 2019, approximately 76.8 percent of services and programs within the system were funded through public expenditure. Private financing accounted for 23.2 percent. The majority of Finnish hospitals are public. Private hospitals provide approximately five percent of hospital care in Finland. Private healthcare, excluding occupational services to prevent work-related illnesses and accidents, accounts for about six percent of total healthcare expenditure. In these districts, university hospitals in the major cities of Finland form the basis of tertiary care and contain the most technologically advanced facilities and medical equipment in the nation. All levels of healthcare are funded by the municipalities, but the national government covers the cost of medical training and participates in financing by providing a general, non-earmarked, subsidy to the municipalities.
The responsibility for organizing health, social and rescue services will be transferred from municipalities to wellbeing services counties starting in 2023. Municipalities will remain responsible for promoting the health and wellbeing of their residents. The public sector will remain as the organizer and primary provider of services. Private sector actors and the third sector will supplement public health and social services. Five collaborative areas for healthcare and social welfare will be created to secure specialized services. People will continue to be allowed to use health and social services across regional boundaries.
Finland is very advanced in its use of IT systems within the healthcare industry, relative to other European nations. According to the European Commission, Finland ranks 5th in terms of the deployment of Health IT within the EU. Individuals within the healthcare system have widespread, simple access to convenient ePrescription and eArchive services via KanTa (The Finnish Electronic Patient Record system). This allows citizens to access their medical records and to gain access to the Picture Archiving and Communications System (PACS), which allows them to see and send relevant information within the healthcare system. The use of electronic patient records among primary health centers and secondary care hospital districts is universal, and it is mandatory for all public health care providers.
Market Entry
As a member of the European Union (EU), Finland’s local legislation concerning medical devices fully comples with EU directives. The Finnish Medicines Agency, Fimea is the national competent authority for regulating pharmaceuticals. As a central administrative agency operating under the Ministry of Social Affairs and Health it promotes the health and safety of the population by regulating medicinal, medical devices, blood and tissue products, biobanks and by developing the pharmaceuticals sector. For more information, visit: https://www.fimea.fi/web/en/frontpage
Medical trade is duty-free within the EU. Import duties are collected from production coming from non-EU countries. Duties assessed on medical equipment imported from the United States vary by product, ranging from 5-12 percent.
Current Market Trends
There are some major hospital construction projects going on in bigger hospital districts during 2020-2030. These projects vary from totally new hospitals to renovated operating rooms and new medical devices. Even if operating budgets in general have been reduced in public hospitals and the procurement is focused primarily on replacing older equipment, several hospitals have reached the end of their lifecycle, forcing the Government to budget more money into them.
High-quality and technically sophisticated medical equipment have market potential in Finland, especially equipment that increases efficiency and reduces occupancy rates in hospitals. Finland also produces high technology medical equipment. Finland is one of the few European countries that export more health technology than they import. The exports of the Finnish health technology industry reached a new record in 2020 as the value of Finland’s exports of health technology products rose to $2.88 billion USD, an increase of 0,5% over 2019. Increasing competition in the market is expected as local production expands.
In general, the market for health technology is expected to rise, but due to the upcoming healthcare reform and the prevailing uncertainties related to it, its expenditures are expected to slow down a little bit for the next couple of years.
In 2020, the Ministry of Finance launched a program called Aurora AI . The task of Aurora is to develop an operating model that organizes public administration activities using artificial intelligence.
Artificial intelligence (AI) solutions are now of interest to Finnish health care providers and their use is growing rapidly. Innovative and agile young companies in Finland are continuously developing new types of solutions for the fast-growing field of health technology that will benefit healthcare professionals and patients globally. The program Artificial Intelligence and Robotics (Hyteairo) launched by the Ministry of Social Affairs and Health in 2018, highlights the goals of the development of robotics and artificial intelligence and the necessary measures as part of the wider digitalization of the welfare sector. The utilization of artificial intelligence and robotics improves people’s well-being and enhances the operation of the service system
Telehealth services are increasing rapidly in Finland and a great factor driving the growth has been COVID-19. Even though the pandemic slows down, telehealth services are still in high demand. Business Finland’s Smart Life Finland program actively seeks to promote the introduction of artificial intelligence and other revolutionary technologies in the fields of healthcare and well-being. The aim is to promote personal, real-time and intelligent health and wellbeing solutions that are accessible anywhere and at any time.
Due to the continuous development of MyKanta pages, citizens’ use of e-health and e-welfare services is expected to rise rapidly in the future.
Best Prospects
Electronic Medical Records (EMR)
Patient monitoring systems
Mini invasive surgery (MIS)
Magnetic resonance imaging (MRI) equipment
Market Size
Healthcare spending (including investment)
$27,61 billion (2019)
9.2 as percent of GDP (2019)
$9.4 billion of which spent on inpatient services (including long-term care) (2019)
$1.66 billion of which spent on investments (2019)
$3.7 billion of which spent on outpatient services (2019)
Hospitals, Procedures, Healthcare Professionals UN
Number of Hospitals:
5 University Hospitals
8 Private
Number of hospital beds (2018)
19,921
284,05 per 100 000 available beds per capita (2018)
19 921 of which in general hospitals
205 of which in rehabilitation centers
380,432 surgical procedures (2019)
Top procedure
49,144 Cataract Surgery (2018)
Second highest procedure
15,739 Dilatation of the coronary artery (2018)
Physicians of working age
21,100 (2018)
of which surgeons
1,436 (2020)
of which internists
1,131 (2020)
of which pediatricians
666 (2020)
Demographics
Population
5.5 million
Life expectancy men/women
79.8/85.1 (2021)
Infant mortality
1.4/1000 live births (2020)
Percent of population older than 65
22.7 percent (2020)
projection, 2030
26.1 percent
Annual deaths
55,488 (2021)
caused by [diseases of the circulatory system]
34 percent (2019)
caused by [neoplasms]
25 percent (2017)
Prevalence of [fastest growing disease burden]
Alzheimer disease, 34.7 percent increase between 2009-2019
Main Competitors
In 2020 the majority of imports of health technology products consisted of medical equipment that accounted 3,2 percent of imported goods. Over 80 percent of the medical equipment imported to Finland comes either from or through the EU. Direct imports from the United States account for 6,7 percent, U.S. being the seventh largest importer to Finland. Other important external supplier countries are Germany, Russia, Sweden, Netherlands, and China. (Tulli, trade statistics, DEA terveysteknologia)
Locally produced healthcare products (primarily medical equipment and pharmaceuticals) are well known for their quality and high technology. In medical equipment, local Finnish companies are the biggest competitors to U.S. companies with strength in dental equipment and specialized x-ray and IVD equipment. In pharmaceuticals, U.S. companies will find competition both from local Finnish companies like Orion, and from the Finnish production operations of global competitors like German Bayer, Japanese Santen, and even other U.S. firms like Pfizer.
Current Demand
High-quality and technically sophisticated U.S. medical equipment has excellent market potential in Finland. The best prospects for U.S.-made medical equipment are in electronic medical records (EMR’s), X-ray equipment, patient monitoring systems, mini-invasive surgery, video endoscopes, digital image processing, and picture archiving. In pharmaceutical products, Finland offers outstanding opportunities for drug target discovery, clinical research and Real-World evidence.
Another trend in the market is mobile health services (mHealth). As mHealth is a rather new phenomenon in the market, a common infrastructure software is currently missing. Finland offers the third-best market prerequisites for the mHealth business among the EU countries. Telemedicine in Finland is expected to gain even more presence because of the continuous improvement of healthcare systems. And, as the population ages rapidly, demand for elderly care services and products is expected to grow.
Registration Process
At the beginning of 2020, Health technology tasks of the National Supervisory Authority of Welfare and Health (Valvira) were transferred to the Finnish Medicines Agency (Fimea), including health care devices and equipment supervision - Duties related to the guidance, supervision and registration of biobanks, the licensing and supervision duties specified in the Act on the Medical Use of Human Organs and Tissues. As well as tasks related to embryo research, and the supervision duties related to the Gene Technology Act. Today, Valvira is charged with the supervision of the social and health care, early childhood education and care, alcohol, and environmental health sector.
Manufacturers domiciled in Finland shall notify their contact details and information on the products they manufacture for the product register maintained by the Finnish Medicines Agency Fimea, if the manufacturer:
- Places medical devices on the market in its own name
Representatives established in Finland must submit the same details.
Extra notification is necessary if the medical product is high-risk and includes IVDs intended for self-testing and if the device contains substance of human origin.
To submit the notification, the party must be:
Notification shall be submitted within two weeks of the device and its conformity procedures meeting legal requirements and the placement of the device on the market, or when the device has been submitted for performance evaluation.
Information on medicinal products and how to register them and introduce to the market can be found by visiting the Finnish Medicines Agency , Fimea website.
Reimbursement
Products that are imported to the market need to fulfill the requirements set by legislation and controlled by Fimea (The Finnish Medicines Agency). The manufacturer needs to give the declaration of conformity and make sure the imported products have a CE label. Fimea also requires the manufacturer to be able to present the necessary documents of the product and to prove that the usage complies with healthcare industry regulations. If these requirements are not met the product cannot be imported to the Finnish market.
As stated in Medical Devices Act 629/2010 (available only in Finnish) all medical devices are required to have markings and instructions ensuring their safe use. Manufacturers are also obliged to provide their contact details either on the device or the package. All markings and instructions must be provided in both Finnish and Swedish.
In May 2022, a new IVD regulation for IVD devices (2017/746) will be fully applicable. The goal of the reform of the rating system is to improve patient safety, while taking into account technological development. At the same time, the rating system has been harmonized more in line with international practices.
Barriers
There are no restrictions on imports in Finland, if they comply with EU requirements. Although marketing requires thorough knowledge of end user needs, the import climate is receptive to equipment that is new and of excellent quality. The market is very competitive.
Procurement & Tenders
Most purchasing of health technology and medical equipment is conducted by public procurement through national boards, agencies, centers, and offices executing charters from the central government. This excludes procurements for private hospitals. The government’s central procurement office, Hansel Ltd , handles framework agreements. Finland is a party of the WTO Government Procurement Agreement, which means that U.S companies can bid on goods to specified government entities on large contracts on an equal footing with Finnish firms.
HILMA is a free electronic database (only in Finnish and Swedish), run by the Finnish Ministry of Economic Affairs and Employment, for actors to announce their upcoming procurements. The database also offers companies the possibility to get information of the ongoing tenders. All public companies, public authorities and the Lutheran and Orthodox Church are obligated to announce their tenders when the value exceeds a certain limit.
When the tender exceeds the EU limit, it should also be announced at TED (Tenders Electronic Daily), the online version of the “Supplement to the Official Journal” of the EU, dedicated to European public procurement. Altogether some 460,000 calls for tenders are published per year via TED, for value of about € 420 billion. Every day, approximately 1,700 public procurement notices are published on the database.
Frequently Asked Questions
1. Is the CE mark enough to export a medical device to Finland? https://www.fimea.fi/web/en/marketing_authorisations/product_information/package_labelling
2. What are the labeling/marking requirements on medical devices in Finland?
3. What are the major sales channels in Finland?
U.S. Commercial Service Contact Information
Name: Ms. Tiina Ketelä-Juvonen tiina.ketela@trade.gov
