07-23-2011, 17:38 PM
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Administrator
Join Date: Jun 2009
Posts: 481
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Italy Import Regulations for Pre-Owned (Used and Refurbished) Medical Devices
General Market Condition: No Restrictions, but CE Mark is Required
See also entry for the European Union.
There are no restrictions or special tariffs on imports of used and refurbished medical equipment into Italy. However, the CE mark is required for all used or refurbished medical equipment and devices, and the same safety standards apply for new and used alike.
Though there are no impediments to the purchase of used and refurbished medical equipment, but the prevailing practice in public hospitals and medical facilities is to purchase new equipment because of liability issues. Public hospitals are forced to comply with current regulatory issues, which mandate that all equipment and devices utilized in public healthcare facilities has to be in accordance with CE mark regulations, in effect from June 1998, by Directive 93/42/EC. The public healthcare service accounts for over 75 percent of expenditures for medical equipment.
The Italian market for used medical equipment is very small and is mostly confined to the private sector. The majority of used medical equipment now available has been on the market prior to the directive, and in most cases does not have the CE Mark, nor does it meet the stringent safety parameters. The process of refurbishing medical equipment to the point of meeting the requirements of the directives and to acquire the CE Mark is very costly and, once completed, makes the selling price of pre-owned equipment prohibitively expensive. Consequently, savings are not enough to justify the purchase of used equipment. To be appealing, the price of used and refurbished medical equipment should be approximately 40 percent less than the selling price of new equipment. Sales of refurbished medical equipment must be supported by pre- and post-sale marketing and technical assistance.
A niche market exists for used and refurbished medical equipment that can be sold to small, privately owned healthcare facilities— which due to their size and specialization are exempted from fully complying with the existing regulations—and to private practitioners. Thus, the best selling used medical products are diagnostic imaging equipment, EKG, monitoring equipment, ultrasonic equipment, ophthalmology equipment, dental chairs and dental equipment, and apparatus and equipment for physical therapy and rehabilitation.
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