Executive Summary
Market Entry
Current Market Trends
Best Prospects
Market Size
Main Competitors
Current Demand
Registration Process
Reimbursement
Barriers
Procurement and Tenders
Trade Events
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 and Tenders
Trade Events
U.S. Commercial Service Contact Information
Executive Summary
Spain has a comprehensive public health system that accounts for approximately 70+ percent of the sector’s activity. The market for medical devices in Spain (consumables, diagnostic imaging, dental, orthopedics and prosthetics, patient aids and other medical devices) is estimated at USD 7.4 billion for 2021.
The sector relies heavily on imports, reported at USD 6.3 billion in 2021. Approximately 60 percent of medical device imports came from the European Union, with Germany and France taking the lead. Most of the well-known U.S. brands are well-established in the Spanish market. Imports from the United States are estimated to be in the 15-20 percent range although it is difficult to confirm the U.S. market share as a portion of the U.S. imports also come through other ports in Europe and/or from U.S. production facilities in other European markets.
Spanish exports have increased continuously over the past several years. Exports of the categories indicated above are reported at approximately USD 2.1 billion in 2021, while exports of a broader range of healthcare categories, including furniture and digital health, are reported at USD 4.4 billion. Approximately 50 percent of Spanish exports are to destinations in the European Union (EU), with Germany, Portugal, Belgium, France, and Italy being the main recipients.
Small and medium sized companies make up 90 percent of the market and account for more than 40 percent of the sales. Large companies account for only 10 percent of the market and generate approximately 60 percent of the sales. Most of the large U.S. and European names are well-established in Spain, with only six percent manufacturing locally.
The strain of meeting the challenges generated by COVID has brought to the surface the need for a deep restructuring of the healthcare system in terms of scope and operation. Reinforcing the healthcare infrastructure, technical renovation and digital transformation are the government’s main areas of priority.
Market Entry
All medical products/equipment imported into Spain need to have the CE Mark. Because of this requirement, many U.S. companies have centralized their import operations into a single country where they register the products which are then distributed to the rest of the EU. Foreign healthcare products cannot be purchased directly via internet. U.S. products that are competitive in price or innovative in the U.S. market and that are already being sold in European markets have a better chance of success in Spain. (EU Medical Device Regulation (EU) 2017/745, (MDR)) came into effect on May 26, 2021. This MDR replaces Directives 93/42/EC and 90/385/EEC meaning that medical devices can no longer be certified under the old directives. Manufacturers are strongly advised to check out the new regulation to ensure compliance with new requirements.
Purchases for the public hospital system are made through public tenders from companies that are pre-selected for public tender opening bids. That is the main reason why having a qualified importer/ distributor with access to the procurement decision makers is so important for U.S. companies. In addition, all importers/distributors of medical equipment and products into Spain need to be resident in the EU and registered with the Spanish Ministry of Health.
The official approach to vitamins and health supplements in Spain is quite different to that of the United States. Spain follows EU legislation covering food and drugs and has a more conservative outlook. Many products commonly found in the U.S. health food stores are still considered by the Spanish Ministry of Health as prescription medicine and need to be approved as such. The approval of products considered drugs can be lengthy. Most healthcare supplements are considered food products and need to meet EU requirements. U.S. companies interested in placing their product on the Spanish market need to provide the Spanish Ministry of Health with technical data on the product’s composition and need to meet the labeling requirements.
Current Market Trends
U.S. medical equipment is highly regarded by Spanish doctors, domestic importers, and distributors. As with most European Union markets, Spain continues to grapple with cost containment measures in the healthcare sector budget, limiting procurement and growth. As a result, the last few years have seen a significant shift in sourcing with more items being imported from Asia. Quality, however, continues to be an important factor in the purchasing decision when it comes to more complex and sophisticated items.
Given the challenges facing importers/distributors for the past several years, more recently exacerbated by the cutback in demand during COVID, many companies currently prefer to focus their efforts on essential rather than on new products, as they are wary of making up-front investments without any guarantee of generating demand. While U.S. products are highly considered in Spain, pricing is now a decisive factor, with the emphasis on cost-effective products and equipment at times overshadowing innovation and quality.
The focus is currently on a return to regular activities, including the need to reduce the waiting list for surgical procedures that had built up during the height of the COVID crisis. On the other hand, the depth of the impact of the crisis on the healthcare system has also crystalized deficiencies in the system and the need for key adjustments to incorporate changes in society, different demands on the system, and innovative ways of moving forward. As a result, the government has identified three broad areas as top priority:
Reinforcement of personnel and infrastructure.
Increased automation, as part of the nation-wide initiative towards greater digitalization, big data, etc.
The renewal of the obsolete equipment (cardiology, respiratory/anesthesia, neurology, orthopedic, MRA, ETP, CT, etc.).
Best Prospects
Areas of focus will be on replacing/upgrading high-tech equipment and infrastructure, swifter transition towards greater digitalization, big data, and increased public-private partnerships, etc. This focus will be spread out over of several years. Many of the objectives will be covered by EU funding that will assigned by the central government to the 17 regional governments to administer, meaning that the pace and nature of the procurements and roll-out of infrastructure could well vary from region to region. Other areas offering good prospects include:
A demand for products directly connected with geriatric ailments and illnesses due the large and ageing population and increasing life expectancy.
The lower cost of treatment will continue to drive the increased interest in minimally invasive technologies, primarily in the areas of cardiology and robotics.
The demand for reputable e-health technology will continue, particularly as the Government rolls out its plan to expand digitalization across the board throughout the country.
Consumables. Asia had become the dominant supplier in recent years, mainly because of greater cost control. It is interesting to note that consumables is one of the more dynamic local sectors, although much of this production is earmarked for export.
Market Size
Healthcare spending (including investment) in 2020 (as of 8/2022)
Euros 122.9 billion (USD145.4 billion)
… Public
Euros 90.3 billion
…Private
Euros 32.5 billion
Hospitals, Procedures, Healthcare Professionals UN:
Number of hospitals
832 (2021)
…Public
464
…Private
368
Number of hospital beds
158,567
…of which in general hospitals
123,062
…of which in specialized clinics and rehabilitation centers
35,505
Number of surgical procedures
5,387,539
…of which top procedure was
Cataracts
…of second highest procedure was
Orthopaedic, digestive, and trauma
Physicians
283,811 registered, 215,000 est. active
…of which surgeons
52,000
…of which internists
11,000
…of which pediatricians
1 2,400; Public health positions: 6,500
Dentists
39,764
Demographics
Population
47.4 million
Life expectancy men/women
81/86
Infant mortality
2.6 deaths/1000 live births
Percent of population older than 65
21
…projection, 2030
25
Annual deaths
449,270 (2021) / 418,703 (2019)
…caused by [highest disease burden]
Cardiovascular/circulatory system
…caused by [second highest]
Cancer
Prevalence of [fastest growing disease burden]
Respiratory system
Source: Data gathered from a variety of sector sources and Spanish Ministry of Health
Main Competitors
The United States and Germany are the two main suppliers, with France, the U.K., Italy and Switzerland following. However, France, the U.K. and Holland are also used as storage and redistribution centers for U.S. companies. Imports from the EU in general represent almost 60 percent of imports. As a result of budget restrictions, imports from Asia are on the rise.
Many suppliers in the Spanish industry are subsidiaries of overseas corporations, including leading U.S. firms. These well-established firms often represent serious competition for NTM companies trying to break into the market.
Current Demand
The focus is currently on facilitating a focused return to regular activities in terms of consultations, as well as hospitalizations and outpatient treatment. Reducing the highest waitlist for surgical procedures in a decade is also a top priority. This should drive an increased demand in almost all areas, including orthopedics and consumables.
Registration Process
Medical products must have the CE mark and need to be registered with the Ministry of Health. The importer/distributor normally works with the U.S. company to get the product registered. Furthermore, companies importing medical products need to have an authorization issued by the Ministry of Health to handle medical products. As indicated above, a result of the development and expansion of the EU market and the requirement for the CE Mark, many U.S. companies have based their operations in a single EU country where they register the products prior to ongoing distribution throughout the EU.
Reimbursement
The official current repayment time allowed in Spain is:
Private companies up to 60 days
Public administrations up to 30 days
Public works up to 60 days
However, despite local legislation which is in line with EU directives covering payments, common practice in Spain is that large corporations and large retailers may negotiate or impose longer payment terms of up to four to six months. The Spanish government has also deferred payments in the past.
Barriers
There are no official barriers as Spain follows EU legislation regarding medical products. However, challenges exist: registration at the Ministry of Health can be time-consuming; the criteria for the selection of products can vary from region to region; certain vitamins, health products and supplements that are OTC items in the United States are considered prescription medicines or food products and need to be approved and registered as such. The registration process for drugs and medicines can be lengthy.
It should be noted, however, that apart from competitive pricing, sector professionals tend to prefer products with a proven track record and, if possible, in use in other European markets. Competition is stiff not only from in-country companies but also from most well-known international suppliers, including numerous U.S. names, that are well-established in the Spanish market.
Procurement and Tenders
Spanish Government procurement follows the principle of best value through competition. There is no official domestic preference policy, or discrimination against foreign suppliers, however the Spanish Government does encourage “full and fair opportunity” for Spanish suppliers.
Following below are the general guidelines for bidding on tenders in Spain. However, in the healthcare sector, the U.S. company must have an authorized representative with residence in Spain or the E.U. and the products must meet all EU and Spanish healthcare requirements, i.e. CE Mark, etc. Normally, authorized distributors present the bids for their U.S. partners.
The procedure to bid for a specific tender is relatively straightforward. All proposals for bids are confidential and must be accompanied by proper documentation. This information should include:
Accreditation of the legal representation used by the company.
Proof of economic and financial ability to meet all obligations and technical or professional competence plus a declaration that the company is not prohibited from contracting.
Proof that a provisional guarantee, as required by the conditions of participation, has been deposited. For foreign companies, formal acceptance of the jurisdiction of the Spanish courts (if necessary).
Accreditation that all fiscal and social security obligations have been met.
U.S. companies interested in bidding for contracts with the Public Administration must comply with the Spanish Public Sector Procurement Law (Ley de Contratos del Sector Público). Companies must also document their compliance with the Spanish Embassy in Washington, D.C.
Embassy of Spainhttp://www.spanish-embassy.com/washington.html https://contrataciondelestado.es/wps/portal/licRecientes
Trade Events
There are no major international trade shows in Spain for medical devices. Spanish professionals visit and exhibit at Medica, the major trade show in Germany in the healthcare sector. Local congresses and conventions organized throughout the country often include an exhibition area.
Please check out the link below for international events scheduled to take place in the coming months: https://www.conferenceseries.com/spain-meetings.com
U.S. Commercial Service Contact Information
Name: Helen Crowley helen.crowley@trade.gov
