Global Import Regulations for

Jamaica

General Market Condition: No Restrictions

Source: Report from CS Post (via E-Mail), 3 May 2000

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

None of which the Post is aware, but all imported equipment should ideally be approved by the Jamaica Bureau of Standards.

Can public health institutions buy used or refurbished medical devices?

Yes, but again subject to the conditions above. All of last year, Y2K was a big thing. Health services were announcing that they would only be buying items that were Y2K compliant.

Is there a market for used or refurbished devices?

In theory there should be, but new items are greatly preferred.

Best prospects?

Unknown.

Japan

General Market Condition: Restricted

Source: Report from CS Post (via E-Mail), 26 March 2002. Information re-confirmed by CS Post, 17 April 2003.

Are there special restrictions or tariffs that apply to used medical equipment?

All imports of used equipment are treated the same as new, and thus each product must obtain MHW (Ministry of Health and Welfare) approval for import.

Although there is no tariffs levied on medical devices, this area is highly regulated by the Pharmaceutical Affairs Law of the Ministry of Health, Labor and Welfare (MHLW). In order to market a foreign medical product in Japan, an importer must obtain “manufacturing approval” (shonin) for safety and efficacy of a medical product. In order to handle a shonin-approved product, an importer or a seller needs to obtain “kyoka” license based on its facility, personnel and qualification of a technical director. A foreign manufacture may obtain the shonin approval by using an in-country care taker (ICC). If a foreign manufacturer receives a shonin approval, an importer is not required to obtain a shonin approval for such items.

In many cases, a Japanese importer receives “manufacturing approval” (shonin). It means that an importer who has a shonin approval will have a full control. If a different importer wishes to sell the same product (either used or new), this importer must receive a product approval from the Ministry. If a U.S. manufacturer holds an approval, they can sell their product through multiple distributors that have “kyoka” license to sell medical devices in Japan. A Japanese doctor can import a medical device to treat his/her patients at his/her risk. However, in this case, no reimbursement is given for those treatments, and thus direct import from Japanese general clinics and hospitals is very limited. Japanese beauty clinicians and veterinarians often import new and used medical device as their treatments have no reimbursement coverage in Japan’s system.

Can public health institutions buy used or refurbished medical devise?

Although there is no statistical information available, used/refurbished medical equipment is becoming more attractive to medical institutions, including public hospitals, because of cost factors. This trend may continue coming years as the financial status of many Japanese hospitals is also becoming more precarious. Over 70 percent of Japanese hospitals are believed to be operating in deficit and the number of hospitals declaring bankruptcy is increasing. More efficient use of used/refurbished medical equipment may be needed to meet these growing financial challenges.

Is there a market for used or refurbished medical devices?

The sale of such equipment in Japan is a more viable option for local manufacturers and re-sellers than for third-party exporters. Industry sources indicated that market demand for such equipment is particularly strong for ultrasonic diagnostic equipment, X-ray equipment, clinical examination/laboratory equipment, etc.

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

The Japan Federation of Medical Devices Associations (JFMDA) has prepared a guide on the handling of second-hand medical devices with the objective of establishing a closer network system between manufacturers and medical facilities and to ensure the safer and more effective use of these devices.

Jordan

General Market Condition: No Restrictions

Source: Report from CS Post (via Cable), 28 June 1998

Equipment is assessed the tariff that applies to its Harmonized Tariff Schedule (HTS) category, regardless of whether it is new or used. The base value of used equipment, however, is depreciated according to the judgment of the customs inspector. Therefore, the net customs levy on used equipment may be lower or even higher than on new equipment, depending on the customs inspector.

No customs duties apply to new or used industrial equipment if it used for production.

Kazakhstan

General Market Condition: No Restrictions

Source: IMI 26, August 1998

Kazakhstan does not have any special regulations for the importation of used/refurbished equipment. This type of equipment can be imported in accordance with regular customs import requirements. Licenses and certificates of conformity may be required for the import of certain types of equipment.

Kazakhstani customs does not distinguish between new and used equipment when being declared for customs clearance. Used equipment is released subject to completion of the customs clearance process which is same as for new equipment. There are no special duties for the importation of used equipment in Kazakhstan.

Licenses are required to import equipment that may affect the health of citizens, the environment, or national security. These types of equipment are subject to mandatory safety certification.

The best industry sectors for the export of certain types of used/refurbished equipment to Kazakhstan are: automotive, oil and gas, power generation, medical, agriculture, and food processing. Subject to the availability of warranties and spare parts, cheap used medical, agricultural, and food processing equipment is believed to have better marketability versus expensive new equipment.