Global Import Regulations for

Spain

General Market Condition: No Restrictions, but CE Mark is Required

See also entry for the European Union.

Source: Report from CS Post (via E-Mail), 11 March 2002

Are there special restrictions or tariffs that apply to used medical equipment that do not apply to new medical Equipment?

No.

Can Public Health Institutions buy used or refurbished medical devices?

Yes.

Is there a market for used or refurbished medical devices?

No. Both private and public health Institutions require new medical devices.

Industry Sector Analysis, Prosthesis/Trauma, 10 October 2001

Representing 31 percent of total imports (USD 500 million), the United States is Spain’s main supplier. U.S. medical equipment is highly regarded by Spanish doctors, domestic importers, and distributors, which consider the U.S. the world leader in this field. The growth in U.S. imports is estimated at 10 percent annually for the next two years. In peseta terms Spanish purchases from the United States have grown 43 percent from 1998-2000. This import figure is only for new equipment. Refurbished medical equipment is allowed to be imported in Spain, but both the public and private medical providers in Spain want only new equipment.

Sri Lanka

General Market Condition: No Restrictions, but Government Healthcare Sector Cannot Buy

Source: Report from CS Post (via E-Mail), 31 March 2002

Are there special restrictions or tariffs that apply to used equipment that do not apply to new medical equipment?

Medical equipment is imported duty free into Sri Lanka. There is no special tariff in the case of used or refurbished medical equipment.

Can public health institutions buy used or refurbished medical devices?

Public Health Institutions are prohibited from buying used or refurbished equipment. The Government health sector is required to purchase only brand new medical equipment.

Is there a market for used or refurbished devices?

According to medical industry sources top private hospitals and medical service providers are not in favor of purchasing used medical equipment. Private medical equipment companies are also not keen to import used/refurbished medical equipment. The key factor is the inability of foreign suppliers of used equipment to provide after sales services, parts and manufacturers’ warranties. However, they see limited prospects for used medical equipment, from smaller hospitals and medical clinics.

If there is a market, what types of used or refurbished medical equipment are in the greatest demand?

Small hospitals, medical and dental clinics may require refurbished dental equipment, and other medical equipment ranging from ECG machines to ultra sound scanners. Well-known U.S. brands would have acceptance in the local market, if refurbished and supplied by the manufacturer. There is little or no demand for used medical equipment supplied by third parties. The key factors would be competitive prices compared to brand new equipment and efficient and comprehensive after sales service.

Sweden

General Market Condition: No Restrictions, but CE Mark is Required

See also entry for the European Union.

Source: Report from CS Post (via E-Mail), 31 March 2000 (Confirmed as still accurate, 26 March 2002)

There are no special restrictions or tariffs that apply to used equipment that do not apply to new medical equipment. (The CE mark required on all medical equipment marketed in Sweden). According to trade association there is no market for used or refurbished medical equipment. When replacing outdated medical equipment the public health institutions prefer to purchase new equipment.

Switzerland

General Market Condition: No Restrictions

Source: Report from CS Post (via E-Mail), 13 March 2001 (Confirmed as still accurate, 15 April 2003)

Switzerland is a small, highly developed and affluent market. It maintains one of the best health care systems in the world. Therefore importation of used medical equipment is practically non-existent. As a matter of fact, hospitals and doctors donate their used medical equipment/furniture to third world countries.

Are there special restrictions or tariffs that apply to used equipment that do not apply to new medical equipment?

The same tariff rates apply to used medical equipment as to new ones.

Can public health institutions buy used or refurbished Medical devices?

Public health institutions can buy used equipment, however, is practically never done.

Is there a market for used of refurbished devices?

No. The market is practically non-existent.

Source: Report from CS Post (via E-Mail), 15 April 2003

A distinction is to be made between a "fully refurbished device" and a used medical device that is in the state of operability and has been subjected to the necessary maintenance, but which has not been upgraded or otherwise altered. An altered or upgraded device ("fully refurbished device") has the identical status as a new device and must therefore be subjected by the refurbisher to a conformity assessment procedure for CE-marking as a new device before it can be placed on the market in its refurbished state. Any used device may be placed on the market provided it is appropriately CE-marked by the original manufacturer.

Switzerland has fully transposed the European Medical Devices Directives 90/385/EEC, 93/42/EEC and 98/79/EC into national law. Due to the Mutual Recognition Agreement with the EU, Switzerland participates in the European Market of Medical Devices. The language requirements for the labeling of devices in Switzerland are German, French and Italian. For certain devices also English may be acceptable. Further details are available from the Medical Devices Ordinance (MDO) at the following website:

www.swissmedic.ch/md.asp

Are there special restrictions or tariffs that apply to used medical equipment that do not apply to new medical equipment?

There are no special restrictions or tariffs that apply to used medical equipment. Items 9018 to 9022 of the Swiss Customs Tariff cover medical devices. Import duty ranges from SF 14.00 to SF 88.00 per 100 kilograms gross weight. In addition a VAT of 7.6 percent is levied. Further information on tariffs can be obtained at:

Federal Customs Administration
Oberzolldirektion
Monbijoustrasse 40
CH-3003 Bern, Switzerland
Tel: [phone]
Fax: [phone]
E-Mail: [e-mail]

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.?

Parallel import of devices is possible. Anyone importing such a device must have the corresponding declaration of conformity (according to the requirements of the EU Directive 93/42/EEC) for the device and the necessary EC-Certificates. If a device of class I is imported from a non-EEA country, there is the obligation to notify Swissmedic (MDO, art. 6). This holds also for custom-made devices and system and procedures packs.

Can Public Health Institutions buy used or refurbished medical devices?

There are no legal provisions in the MDO prohibiting a Public Health Institution from buying or importing a used or refurbished medical device—as long as the conformity of this device can be demonstrated according to the requirements of 93/42/EEC and the importing party fulfills notification requirements (MDO art. 6) as well as the product surveillance responsibilities (MDO, sect. 5).

Is there a market for used or refurbished medical device?

There are no statistical data on the Swiss market of used and refurbished devices. However, this market is appears to be characterized by export activities.