The Italian market for medical equipment & supplies ranks sixth in the world and third in Europe following Germany and France.  Italy is a mature market for medical equipment and its high per capita income and sophisticated healthcare system translate into demand for a broad range of cutting-edge medical equipment.  Italians are educated consumers and expect state-of-the art medical equipment, which ensures continuous demand for innovative medical equipment and products.

Italian manufacturing sector has strongly specialized its production with great efficiency in fields like X-ray equipment, cardiology equipment, implantable pacemakers, operating theatre equipment, anesthesia equipment, respiratory apparatus, dialysis equipment and dental products ranging from instruments to dental chairs. 

The Italian National Healthcare System (SSN) was established in 1978 to provide essentially free medical care at the point of use to all Italians. Thus, the SSN is by far the major healthcare provider in Italy. The 20 Italian Regions, which have the primary role in setting and implementing healthcare policies, are responsible for developing regional health plans and for organizing and delivering healthcare services through local "Health Units".  Regions, and not the central government, are responsible for any deficits and are required to cover them by instituting co-payments and increasing regional taxation. The SSN receives its funding through the National Health Fund, appropriated every year through the Government of Italy’s budgetary legislation.

Public healthcare accounts for 80 percent of total expenditures for medical equipment and products, with the remainder being spent by private healthcare facilities.  In addition, the SSN purchases a significant portion of healthcare services from private providers.  The SSN has jurisdiction over 196 large hospitals as well as 600 medium and small size hospitals, which are managed by 197 Local Health Authorities.  The total number of beds in the public sector is 220,932.

In addition, public healthcare manages 7,079 outpatient facilities, 1506 residential facilities for the elderly and 4,794 other healthcare facilities.  Private healthcare service providers account for 637 private and independently operated clinics of which 531 are endorsed and operate within the SSN.  A geographic map of public and private health care institutions indicates that while public hospitals are very numerous in the northern regions and evenly distributed in central Italy, private clinics dominate in the South.

Private clinics operate with more flexibility and have independent financial means, and can thereby circumvent the cumbersome purchasing procedures and the financial limitations faced by public hospitals.  

Public hospitals, which make up 60 percent of total healthcare institutions, account for over 80 percent of total equipment purchases.  It is estimated that a significant number of U.S. manufacturers of medical equipment are present in the Italian healthcare market.  Some American suppliers maintain wholly owned subsidiaries in Italy and sell equipment imported from the United States or from plants in other foreign countries.  Another significant American presence is that consisting of the numerous companies represented by local importers and distributors.  Since U.S. technology and standards are highly regarded and recognized, American companies will maintain their excellent market position in the future.  

Best Products/Services

The best sales potential for U.S. manufactured medical equipment is in the following areas:  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, monitoring equipment, telemedicine equipment and services.  A large percentage of medical equipment in Italian healthcare facilities is obsolete, and it is estimated that 30-35 percent are in need of replacement.  A replacement policy is gradually taking place.  The Italian market is receptive to high quality and technologically advanced diagnostics and therapeutic equipment and products.  

The Italian market for medical equipment is highly dependent on imports.  Major suppliers are the United States, Germany, France and Japan.  Domestic production is competitive in such areas as radiology, ultrasonic medical equipment and various segments of the overall dental sector.  It is, however, limited with respect to the most sophisticated medical products and equipment for which investments in R&D are of critical importance. 

Opportunities

It is up to Regional Governments to issue specific regulations governing procurement of medical equipment.  Most purchases are made by public tender and are open to both domestic and foreign companies.  Announcements of tenders on public procurements are monitored by the U.S. Mission to the European Union and can be accessed through the webpage: www.buyusa.gov/europeanunion. In general, it is unrealistic for a foreign firm to believe that it can navigate the cumbersome bureaucratic procedure of public procurement without having a base in Italy or a strategic Italian partner. Companies which want to participate in public tenders must first qualify by submitting adequate evidence of their business experience and professional expertise.

All medical devices marketed in the EU must bear the CE mark to certify conformity with EU law.  Member States have appointed certification authorities or "notified" bodies to grant these compliance certificates. U.S. medical equipment receives duty-free treatment in Italy.

New registration procedures (on-line) for medical devices have been introduced by the Italian Ministry of Health (MOH) through Italian Decree laws available on the Ministry's website in Italian only.  The new system, according to the Ministry of Health, is intended to improve the previous registration procedures and also enhance device traceability.  A registration number will be assigned to each medical device and the new data bank will be used to generate a  list of medical devices referred to as a  "Repertorio" that are sold to the Italian National Health System (Servizio Sanitario Nazionale).  Companies interested in selling to the Italian National Health System should be included in the "Repertorio" and are required to pay a fee of Euro 100 for each device or group of devices that have the same registration.

The registration procedure appears to be rather complicated and there are approximately 50 questions to be answered regarding the medical device.  It is therefore suggested that U.S. companies designate a third party in Italy to register.  The Ministry of Health’s website is as follows:http://www.ministerosalute.it/dispositivi/paginainterna.jsp?id=395&menu=registrazione

Recently the EU has initiated an infringement action against Italy regarding Italy’s registration requirement for medical devices.  There are no other 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 at the following address:  40 Boulevard du Regent, 1000 Brussels, Belgium, tel.:  32 2 5082746; fax: 32 2 5131228.  The Italian institutions responsible for product standards and certification in Italy are listed in the contacts section below.

Trade Fairs

Though Italy does not have any international trade fairs that can compare to the major German healthcare trade shows, the following is the leading Italian show in this sector, which has been growing over the years.  The show attracts over 27,103 visitors and has over 1000 exhibitors.   The U.S. Commercial Service in Italy organizes a U.S. Pavilion.   

EXPOSANITÁ
(held every two years)
Date: 2010
Site: Bologna Fairgrounds
Organizer: Senaf s.r.l.
Via Michelino 69
40127 Bologna, Italy
Phone:  +39-051-503318
Fax:  +39-051-505282
info.bo@N0SPAM.senaf.it
www.senaf.it 

S.I.R.M. 

A more specialized exhibition/congress is “SIRM”, held every two years and sponsored by the Italian Radiological Society. The next edition will be held in June 2009.  The SIRM congress is highly specialized and is the recognized forum for diagnostic imaging equipment in general.
Date: 11 – 15 June 2010
Site: Verona Fairgrounds
Organizer: S.I.R.M.
Via della Signora 2
20122 Milano
E-mail: segreteria@N0SPAM.sirm.org
Tel. +39 02 7600 6094 – +39 02 7600 6124
Fax +39 02 7600 6108

The U.S. Commercial Service contact for promotion of U.S. medical products in Italy is:

Leonarda Chiocchi, Commercial Specialist
Phone: +39 06 4674 2204
Fax: +39 0646742113
Email: Leonarda.Chiocchi@N0SPAM.mail.doc.gov

Resources 

AIOP - Associazione Italiana Ospedalità Privata

(Italian Association of Private Hospitals)
Via Lucrezio Caro, 67
00193 Roma
Phone: +39-06-3215653, Fax:  +39-06-3215703
E-mail: aiop@N0SPAM.aiop.it
Web: www.aiop.it

ANIE - (Italian Association of Electrical Industries)

Via Gattamelata 34
20149 Milano
Phone: +39-02-3264.1
Fax: +39-02-3264256
Web: www.elettronet.it
 

ASSOBIOMEDICA - Italian Association of Medical Equipment Manufacturers
Via Giovanni da Procida, 11
20149 Milan
Tel.: +39 02 34531165; Fax: +39 02 34592072 www.Assobiomedica.it

 
Ministero della Salute
Ministry of Health
Viale della Civilta’ Romana, 7
00144 Rome
Tel: +39 065994 3697
www.ministerosalute.it