Medical Equipment >> Italy

Medical Equipment
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Italy Market

Overview: The Italian market for medical equipment & supplies ranks sixth in the world and third in Europe, after 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. The 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% 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, 1,506 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% of total healthcare institutions, account for over 80% 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 U.S. 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.

A large percentage of medical equipment in Italian healthcare facilities is obsolete, and it is estimated that 30-35% 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 U.S., 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.

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. 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.

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.

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High frequency medical lasers; Endoscopes & imaging equipment; Non-invasive and micro-surgery devices; Anesthesiology equipment; EKG; Stimulators and defibrillators; Monitoring equipment; and Telemedicine equipment and services.

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