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

**admin** · 07-23-2011, 17:51 PM

General Market Condition: No Restrictions, but CE Mark is Required
Are there special restrictions or tariffs that apply to used medical equipment that do not apply to new medical equipment?
No, there are no special restrictions or tariffs that apply to used medical equipment. The same rule applies to both new and used medical equipment. In general, Norway follows EU and European Economic Area (EEA) directives. Norway requires the CE mark on all medical equipment, used or new.
Concerning registration of companies and their devices, Norway has chosen to go a little further nationally than what is strictly required by the EU directives. Obligation to register with the Norwegian Register for Medical Devices, Manufacturers and Distributors is incumbent upon all companies manufacturing or trading with medical devices, and with a business address in Norway. A company may be a manufacturer, a manufacturer's authorized representative in the EEA, a sole distributor, a distributor, or a combination thereof. The national authority overseeing this register is the Norwegian Directorate for Health and Social Affairs.
If a manufacturer or its agent has registered a medical device in the country, can a third party legally import the same device in used/refurbished condition without the used device being subjected to new safety inspections, etc.?
No, the third party must still register the product and the company with the Norwegian Register for Medical Devices, Manufacturers and Distributors and the product must still carry the CE mark.
Can public health institutions buy used or refurbished medical devices?
Yes, they are allowed to buy used or refurbished medical equipment as long as the products comply with current regulations, but so far there has been no indication that they are interested in doing so.
Is there a market for used or refurbished medical devices?
According to Norwegian government, procurement and trade association sources there has not been a market for used or refurbished medical equipment. When replacing outdated medical equipment the public health institutions prefer to purchase new equipment.
If there is a market, what types of used or refurbished medical equipment are in greatest demand?
Not applicable.

Thread Tools	Search this Thread
Show Printable Version Email this Page	Search this Thread: Advanced Search

Similar Threads
Thread	Thread Starter	Forum	Replies	Last Post
Ghana Import Regulations for Pre-Owned (Used and Refurbished) Medical Devices	admin	Other Regions	0	07-23-2011 17:28 PM
Germany Import Regulations for Pre-Owned (Used and Refurbished) Medical Devices	admin	Europe	0	07-23-2011 17:27 PM
France Import Regulations for Pre-Owned (Used and Refurbished) Medical Devices	admin	Europe	0	07-23-2011 17:26 PM
Finland Import Regulations for Pre-Owned (Used and Refurbished) Medical Devices	admin	Europe	0	07-23-2011 17:24 PM
Australia Import Regulations for Pre-Owned (Used and Refurbished) Medical Devices	admin	Other Regions	0	07-22-2011 00:21 AM