Global Import Regulations for

Norway

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

See also the entry for the European Community.

Source: Report from CS Post (via E-Mail), 14 April 2003

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 When replacing outdated medical equipment the public health institutions prefer to purchase new equipment.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.

Oman

General Market Condition: No Restrictions, but Ministry of Health Does Not Buy

Source: Report from CS Post (via Cable), 29 March 2000 (Updated and Corrected by CS Post (via Cable), 2 April 2001)

The Ministry of Health is the main buyer of medical equipment in Oman. As a matter of practice, the Ministry of Health does not purchase used or refurbished medical equipment. Normally, when the ministry decides to purchase equipment, it contacts regular suppliers and requests the latest equipment; in some cases such purchases are conducted through tenders. Generally, equipment is purchased along with a minimum five-year maintenance contract.

Post does not know of any special restrictions or tariffs that apply to used medical equipment that do not apply to new medical equipment.

Given the Ministry of Health’s practice of purchasing new equipment only, prospects for sales of used and refurbished medical equipment in Oman remains extremely limited. It is possible that private hospitals and clinics could be potential purchasers of used medical equipment since their procurement does not go through the Ministry of Health. However, at this time, there are only two private hospitals in Oman.

Pakistan

General Market Condition: Restricted

Source: Report from CS Post (via E-Mail), 6 April 2001

Pakistan offers a promising market for used or reconditioned medical equipment and devices such as diagnostic equipment, electro-medical apparatus and laboratory equipment. Demand is expected to grow at an accelerated rate for items such as dialysis machines, diagnostic equipment, electro-cardiographs, scanners and X-ray apparatus.

In recent years, thousands of new medical centers have been set up all over the country. The majority of these private centers/clinics are run by reputable medical professionals. The increasing involvement of the private sector in health facilities is a positive development for U.S. suppliers of used medical equipment to consider marketing their products in Pakistan.

Under the import policy for 1999-2000, customs duty and sales tax on used medical equipment are as follows:

Summary of Import Policy Order, 1999-2000 For Used Medical Equipment

HS Code	Description of Goods	Relevant Rules Under Import Policy Order 1999-2000
9018.1 to 9018.19	Second hand or used surgical equipment like dialysis machines and electro-medical equipment	Import shall be allowed subject to the condition that these are not more than five years old.
9018.13	Second-hand/used diagnostic equipment
9018.19	Testing equipment/analytical	Import of this equipment shall be
9024	Equipment including CT scanner	allowed if importer arranges for the
9026	MRI equipment, etc.	foreign exchange resources.
9027	Instruments for physical and chemical analysis
9030	Instruments for measuring and testing electricity and electrical signals
9031	Other measuring and checking instruments

Customs and Sales Tax

Customs duty and sales tax on imported used medical equipment is as follows:

Customs Duty and Sales Tax on Imported Used Medical Equipment

HS Code	Description Of Goods	Customs Duty (ad valorem)	Sales Tax on Imports
9018.1100	Electro-cardiographs	10%	15%
9018.1200	Ultrasonic scanning apparatus	10%	15%
9018.3100	Syringes with or without needles	25%	15%
9018.9070	Cine angiography film equipment	10%	15%
9022	Apparatus based on the use of X-rays	15%	15%

Customs Duty and Tax Exemptions on the Items Imported by Non-Profit Institutions

Below is a list of used medical equipment that, if imported by a charitable non-profit institution or by a hospital run by the Federal or provincial government, is exempt from customs duty and sales tax:

Used Medical Equipment Exempt from Customs Duty and Sales Tax
if Imported by Charitable, Non-Profit Institutions or
Hospitals Run by the Federal or Provincial Government

HS Code	Description of Goods
9018.11	Electrocardiographs
9018.12	Ultrasonic scanning apparatus
9018.13	Magnetic resonance imaging apparatus
9018.14	Scintigraphic apparatus
9018.19	ETT machine, Echocardiography, Electro-cenephlograph, Radio-isotope scanners,
9018.90	Angioplasty balloon, Cardiac catheters, Endoscopy equipment
9018.80	Dialysis equipment
9018	Medical instruments

Source: ISA Medical, 1 March 1998

Public sector hospitals procure medical equipment through tenders whereas private hospitals obtain these through distributors and suppliers who can ensure quality, technical services, and backup supplies. U.S. manufacturers benefit by appointing agents in Pakistan’s major cities to market their superior quality products. Used/reconditioned equipment is often preferred as the private sector is price-driven. Import duties and sales tax were reduced in 1997.

Private sector health care is a significant factor in the market as more private hospitals are being established, generating a demand for imported equipment. Most private hospitals and clinics are set up as commercial ventures by local or expatriate Pakistani doctors. Most of these end-users seek either used or reconditioned equipment or, if new, they source it from the cheapest supplier.

The equipment listed above is imported either new or used. Generally, the following considerations are taken into account by end users when deciding between new or used machinery/equipment:

• 
  Size—When the end user is a large hospital/organization, the preference is for new machinery/equipment.
  
• 
  Value—When high value machinery is imported, and there is an appreciable difference in the price of new and used items, the preference is for used items, e.g. magnetic resonance imaging system, computerized tomography scanners.
  
• 
  Basic Use Items—When the machinery/equipment to be imported is basic, involving simple technology, the preference is to import new items, e.g. ultra sound scanners, ophthalmic appliances.
  

Source: ISA Laboratory, 1 October 1998

Most laboratory and analytical equipment is being imported—either new, used or in reconditioned form. The general criteria for importing new machinery are low prices and appropriate technology. For example, basic items are imported new; the relatively expensive items are imported both in new and used forms. Larger hospitals generally prefer new items even if they are expensive, but the smaller laboratories or individual doctors prefer used items.