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Old 07-22-2011, 00:33 AM   #1 (permalink)
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Default Import Regulations for Pre-Owned (Used and Refurbished) Medical Devices -Canada


General Market Condition: Restricted
The content of ISA Medical 970901 ( see below ) concerning used/refurbished medical equipment remains fairly current with the following observations and additions:
Although we remain unable to quantify this market, it is fair to assume that demand for used/refurbished medical equipment has grown in Canada over the past three years. It remains minimal in comparison to the total market. It is in the area of refurbishing for existing customers that most market gains would have been achieved in recent years. Surgical endoscopes, both rigid and flexible, is one popular product for refurbishing for existing customers.
Equipment maintenance people in Canadian public hospitals have had to face more budget cuts in the second half of the 1990s. They have learned to use the Internet to access used/refurbished medical equipment businesses on web sites that proliferate and are believed to conduct more sourcing for in-house reconditioning. There is also an occasional demand for used and refurbished equipment destined to backup support, particularly in blood and bio-chemistry laboratories.
Some market gains have been made by private health care businesses in Canada in the past few years, namely in the laboratory, diagnostic, as well as in aesthetic and minor surgery fields. Many of these businesses are strong potential buyers of used/refurbished equipment.
The large demand created by Canada's 950+ network of public hospitals is essentially for new, state-of-the-art medical equipment.
Sources at Health Canada's Medical Device Bureau indicated that used medical equipment refurbished for resale/exports to Canada would be subjected to licensing like new equipment, unless the refurbisher is the original manufacturer that originally obtained licensing for the equipment in Canada. In these cases, the review for licensing clearance would be conducted based only on the specification changes made to the equipment.
Although minimal in volume, sales of used/refurbished medical laboratory equipment may be expected to show growth over the next two years in Canada.
Used and refurbished medical laboratory equipment
Difficult to quantify, sales of used and refurbished medical laboratory equipment in Canada appear to be minimal in relation to total market sales. The purchase of used and refurbished equipment does not fit well with Canada's current public hospital procurement practices. Amortization, manufacturers' warranties, personnel training, and long term servicing arrangements constitute the most important buying criteria. Some used and refurbished equipment may find a place in public hospital laboratories for backup support, provided it can be serviced by the same company that sells and services the newer, more advanced equipment. This seems to be the case for blood and chemistry analyzers. Only US-made used and refurbished instruments appear to be purchased by Canadian hospital laboratories.
Future privatization of healthcare delivery services in Canada could affect the market for used and refurbished medical laboratory equipment, presenting new opportunities. However, no major new legislation in favor of privatization of healthcare in Canada is anticipated in 1997 and 1998. Market conditions are therefore not anticipated to change for at least the next two to three years.
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