Executive Summary
Market Entry
Current Market Trends
Best Prospects
Market Size
Main Competitors
Current Demand
Registration Process
Reimbursement
Barriers
Procurement & Tenders
FAQs
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
FAQs
U.S. Commercial Service Contact Information
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Executive Summary
Italy is a mature market for medical equipment, and its high per capita income and sophisticated healthcare system translates into demand for a broad range of cutting-edge medical equipment. The Italian market for medical equipment and supplies is the fourth largest in Europe following Germany, France and the UK with about 4,546 companies (including 42% distributors, 53% producers and 5% service providers) and a workforce of 112,534 people. The medical device market (including dental and optical devices) was valued at approximately $9.8 billion USD in 2020 with imports accounting for $6.7 billion USD. Aside from other medical devices, consumable products represent the largest market segment (19.7%) followed by diagnostic imaging (16.7%), and patient aids (15.2%). COVID-19 has negatively affected the medical devices market growth in Italy. While there has been a significant increase in demand for personal protective equipment and ventilators, demand in other product categories, especially orthopedical and dental devices, has declined.
The Italian government is the primary purchaser of medical equipment. Public hospitals account for over 75% of medical device sales, while the remaining 25%of sales are made to the private sector. Despite having a considerable local manufacturing industry, the domestic market for medical equipment is highly dependent on imports. Major suppliers are The Netherlands, Germany, Belgium, France, China and the United States, which had a 5.3% share of Italian imports, valued at $367 million USD in 2020. Major US imports are in diagnostic imaging, and dental and patient aids.
Italian Medical Devices Market
2019
2020
2021
Estimated
2022
Estimated
Total Market Size
10,243
9,873
11,620
11,860
Total Local Production
8,081
7,526
8,777
8,952
Total Exports
4,704
4,450
4,957
5,056
Total Imports
6,866
6,797
7,800
7,956
Imports from the U.S.
392
367
395
398
* The above statistics are unofficial estimates. They are based on reports from: Fitch Solutions and Assobiomedica. Exchange rate 1 USD = EUR 0.81 (2019)
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Market Entry
The Italian government has implemented various European Union (EU) directives and regulations related to medical devices, and U.S. companies must be prepared to comply with Italian and EU legislation.
It is up to the Regional Governments to issue specific regulations governing the procurement of medical equipment. Most purchases are made by public tenders open to both domestic and foreign companies.
All medical devices marketed in the EU must bear the CE mark to certify conformity with EU legislation. Member States have appointed certification authorities or “notified” bodies to grant these compliance certificates.
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Current Market Trends
Although the Italian domestic medical market (including dental and optical medical devices) was estimated at approximately $9.8 billion USD in 2020 and is expected to grow by 1 or 2% in 2021, there are major constraints to the sector development. The two most significant factors are the healthcare cost-containment measures together with the late payment of public hospitals, which account for 70% of medical devices sales.
Italy imports primarily from The Netherlands (25.8%), Germany (21.7%), Belgium (11.2%), France (8.8 %), China (6.9%) and the United States (5.3%). However, Netherlands and Belgium are the medical devices warehouse hubs for all major multinationals, including the United States. Imports of US manufactured devices are coming to Italy through those countries. From the Netherlands, Italy is mainly importing diagnostic imaging and orthopedic & prosthetics and from Belgium consumables. Between 2019 and 2022 imports from China have increased by 15.1%.
Italy also maintains a strong position in major subsectors including diagnostic imaging, orthopedics and prosthetics, biomedical instruments and electro medical diagnostics. Regions with the highest concentration of medical devices companies are in Northern Italy.
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Best Prospects
• Highly innovative products improving patient treatments or providing cost-efficient outcomes are on demand.
• Focus on preventive care will increase demand for POC diagnostic products. Government announced a 235-million-euro investment to provide general practitioners with first level diagnostic instruments.
• National Recovery and Resilience Plan (NRRP) includes investment of EUR 1.18 billion to replace obsolete equipment (CT scans, MRI, linear accelerators, ultrasounds, mammographs) and EUR 1.45 billion for digitalization of hospitals.
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Market Size
Healthcare Spending (Including Investment)
…as percent of GDP
9.8%
… of which spent on inpatient services (including long-term care)
109,934 mln
… of which spent on pharmaceuticals/consumables
35,250 mln
… of which spent on investments
N/A
… of which spent on outpatient services
N/A
Hospitals, Procedures, Healthcare Professionals (Source: Albanian Institute of Statistics)
Number of Hospitals
942
… Public
471
… Private
471
Number of Hospital Beds
200,272
… available beds per 1000
3.3
… of which in general hospitals
137,420
… of which in specialized clinics and rehab centers
62,852
Number of Surgical Procedures
9,558,000
Physicians
253,835
… of which surgeons
59,830
Nurses
354,120
Dentists
46,529
Demographics (Source: Albanian Institute of Statistics)
Population
60.5 million
Life expectancy men/women
81.5/85.7
Infant mortality
2.4
Percent of population older than 65
23.3%
…projection, 2030
26.1
Annual Deaths
646,400
…caused by [cardiovascular diseases]
239,527
…caused by [cancer]
178,872
Data sources: BMI, Istat, OECD Stat.
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Main Competitors
Foreign companies represent 8.2% of the total number of companies producing medical devices. Industry giants such Siemens, Philips, Hitachi and Toshiba are well represented in the market. A significant number of U.S. manufacturers of medical equipment are also present in the Italian healthcare market (about 60 companies with 5,700 employees and $2.7 billion USD domestic revenue). Some U.S. suppliers maintain wholly owned subsidiaries in Italy and sell equipment imported from the United States or from plants in other foreign countries, such as Johnson & Johnson, Medtronic, and GE Healthcare.
Italian companies are typically small or medium sized and are mainly concentrated in six regions: Lombardy, Emilia Romagna, Veneto, Lazio, Toscana and Piemonte. The sector is highly innovative and there are about 298 start-ups among which 67 % received public financing.
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Current Demand
Medical Devices
The best sales potential for U.S. manufactured medical equipment is in the following areas: home care equipment, remote monitoring equipment, high frequency medical lasers (for multiple applications), endoscopes and diagnostic imaging equipment, non-invasive and micro-surgery devices and equipment, anesthesiology equipment, EKG, stimulators and defibrillators, ophthalmic equipment, monitoring equipment, telemedicine equipment and services. The Italian market is receptive to high quality and technologically advanced diagnostics and therapeutic equipment and products.
At the beginning of 2020, the Italian government, hoping to improve local healthcare assistance to patients and reduce emergency room dependency, allocated €235 million for basic diagnostics devices acquisition. These devices for general practitioners include ECG, spirometers, holters, dermo scopes, ultrasound devices (EcoFAST), as well as health IT platforms.
Recently the government presented the National Resilience and Recovery Plan for healthcare, which includes an investment of €1.18 billion to replace obsolete medical equipment. The purchase of 3,133 devices will include CT scans, MRIs, linear accelerators, fixed X-ray systems, angiographs, gamma cameras, PET CT scans, mammographs, and ultrasound devices. Procurement is expected to occur at the end of 2024. Additionally, €1.45 billion will be invested in 280 hospitals to improve the digitalization across the facilities to include surgery units, LISS, laboratory information systems, pharmacy services, emergency rooms, triage, drug prescriptions, diagnostics, repository, and scheduling.
e-Health
COVID-19 has demonstrated the need for e-health solutions to improve the Italian healthcare system. The information technology applied to the healthcare systems is a key enabler for delivering more effective and efficient health care. In 2019 in Italy, the ICT expenditure in healthcare was $1.8 billion USD, corresponding to 1.2% of the total healthcare expenditure, which is less than other developed countries which average at around 2.5-3%. Despite the 5% increase compared to 2018, expenditures the adoption of digital instruments in healthcare remains fragmented.
One of the Recovery Plan healthcare priorities is to invest in e-Health technology infrastructure and the Electronic Medical Record (EMR), for which the government has allocated €1.67 billion. Currently, the EMR is activated in 21 regions but is only used by 12% of the population. Another €1 billion will be invested in telemedicine to enhance healthcare assistance at the local level by allowing patients to stay home.
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Registration Process
All medical products and equipment imported into Italy require a notification to the Italian Ministry of Health (MOH). The designated competent authority for medical devices is the Directorate General of Medical Devices and Pharmaceutical Services at the Ministry of Health.
All new–to-market medical devices must go through an online device registration process with the Italian Ministry of Health to be placed in the Italian market. Information on registration procedures is available on the Ministry of Health’s website (in English) as follows:https://www.salute.gov.it/portale/temi/p2_6.jsp?lingua=italiano&id=5715&area=dispositivi-medici&menu=registrazione&tab=1
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Reimbursement
In October 2012, the Ministry of Health determined the maximum reimbursement rates for the compensation of services provided in the hospital sector and in the rehabilitation and long-term care.
Both public and private health providers are reimbursed through a fee-for-service system based on the relevant tariffs. The reimbursement rates are defined in three tariffs at the national level.
• Nomenclature tariff of specialty ambulatory care (Nomenclatore tariffario dell’assistenza specialistica ambulatoriale);
Italy has faced in the past long payment delays from the public healthcare institutions. In the last few years, the average time to pay is gradually being reduced. According to Confindustria Dispositivi Medici (the Italian trade association for medical devices), the average payment time was 85 days in 2020.
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Barriers
There are no significant trade barriers or limitations on imports of U.S. goods. Technical specifications are essentially those established by the EU, which have been incorporated into Italian law.
Official technical norms are issued by UNI, the Italian Standards Institute, and electrical norms are from CEI, the Italian Electro technical Standards Institute. Information on EU standards is available from the Commercial Service Office at the U.S. Mission to the European Union (https://www.trade.gov/european-union ).
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Procurement & Tenders
Healthcare procurement has been rationalized and re-organized at regional level with a procurement organization for each region. Several tenders for medical equipment are handled at national level by Consip, a company of the Ministry of Finance.
• Healthcare Procurement: (regional level): https://www.acquistinretepa.it/opencms/opencms/program_eng.html http://www.consip.it/bandi-di-gara/gare-e-avvisi http://www.salute.gov.it/portale/temi/p2_6.jsp?lingua=italiano&id=1299&area=programmazioneSanitariaLea&menu=vuoto
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FAQs
1. Is the CE mark enough to export a medical device to Italy?
No. In order to export a medical device to Italy, the device, bearing a CE mark, needs to be registered with the Italian Ministry of Health (see info above). It is a registration not an approval. It is very important that the device is registered otherwise it may not enter the country. The registration can be done either by the manufacturer or the distributor. In any case the device registration is in the name of the manufacturer even if the administrative paperwork is submitted by the distributor.
2. What is the custom import health clearance (nulla osta sanitario)?
All medical devices entering the Italian market will be checked at customs, which will issue an import health and safety clearance. To obtain the clearance the following documents are required: Declaration of Conformity, CE certificate, Registration Number from the Italian Medical Device Registry, Product labeling (as required in the EU directive): CE marking, authorized representative, Serial number/lot number, Lot numbers: all lot numbers need to be reported, preferably on the invoice but if this is not possible on the bill of entry.
3. What are the major sales channels in Italy?
There are two principal sales channels for medical devices served by diverse group of distributors, one for the hospitals/clinics and one for the pharmacies/orthopedic shops. Regarding the expanding online sales channel, Italian customers are still cautious, despite the increasing use of internet.
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U.S. Commercial Service Contact Information
Name: Kira Migliorini Kira.Migliorini@trade.gov
