Netherlands Import Regulations for Pre-Owned (Used and Refurbished) Medical Devices - Customs Forum

**admin** · 07-23-2011, 17:47 PM

General Market Condition: No Restrictions, but CE Mark is Required
Are there special import duties or restrictions on used medical equipment that don't apply to new medical equipment?
No. The Netherlands has no import restrictions specifically applicable to the importation of used equipment. Imports of used equipment are treated in the same way as new products.
If a manufacturer or its agent has registered a medical device in the Netherlands, can a third party legally import the same device in used or refurbished condition without the used device being subject to new safety inspections?
Because sales of used equipment in the Netherlands need to be approved by the original manufacturer, the device should not be subject to new safety inspections. Most used equipment imported into the Netherlands is not sold here but is refurbished and exported to developing countries.
Can Dutch public health institutions buy used or refurbished medical devices?
Yes.
Is there a market for used or refurbished medical devices?
The market for used and refurbished equipment plays a minor role in the Dutch economy. A relatively high standard of living combined with government incentives and tax deductions stimulate the purchase of new as opposed to used equipment. Equipment in the Netherlands is usually replaced long before its technical value has expired. In the respect, the Netherlands exports significant quantities of use equipment itself. Refurbished medical equipment is one area where there is potential for US suppliers. Budget cuts and the necessity to save money on large capital outlays are forcing Dutch hospitals to consider purchasing refurbished equipment. However, there is still resistance to buying used medical equipment within the sector. The Dutch manufacturer Philips Medical System now offers a line of refurbished Philips diagnostic equipment under the name Philips Select .

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