Global Import Regulations for

New Zealand

General Market Condition: No Restrictions

Source: Report from CS Post (via E-Mail), 2 May 2000

New Zealand’s current legislation controlling the manufacture, import and distribution of medical devices (including used medical devices) is expected to change when the New Zealand and Australian Governments finalize their discussions on a joint therapeutic goods regulatory body. The discussions are still at a preliminary stage, but once the consulting process is completed and new legislation is passed by both the Australian and New Zealand Governments, no medical device will be accepted into New Zealand unless it is recorded on the joint register. There will be various criteria for a device to be accepted on the register. It is expected the proposed joint regulatory body will be operative in 1-2 years time.

Under the existing regulation, it is possible to import medical devices into New Zealand (provided they meet internationally-recognized standards) with very little Government intervention. The existing legislation does not require medical devices to be registered. The market relies on compliance by importers and manufacturers to established standards that is enforced by post-market surveillance. Medsafe is the Government agency that oversees the post-market surveillance.

Though existing legislation makes it possible to import used medical equipment into New Zealand Medsafe could intervene if it had concerns over the safety of used equipment. As a result and in view of this country’s medical device legislation soon changing, medical device companies looking to do business in New Zealand should contact Medsafe first before entering this marketplace. The business contact details are:

Trevor Nisbet Senior Adviser (Science) Medsafe Public Health Directorate Ministry of Health PO Box 5013 Wellington New Zealand

Ph: 64 (4) 496-2364 Fax: [phone] Website: www.moh.govt.nz Email: [e-mail]

Nicaragua

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

Source: Report from CS Post (via Cable), 27 March 2000

According to the Nicaraguan Customs Department and Ministry of Health, there are no restrictions for the importation of new, used and/or refurbished medical equipment into Nicaragua. New, used and/or refurbished medical equipment have a zero percent tariff.

The Nicaraguan Ministry of Health only purchases new equipment. Local clinics and private hospital do purchase used or refurbished medical equipment.

Our assessment is that there is a market for used or refurbished equipment.

Best prospects include intensive care, surgical, laboratory and X-ray equipment.

Import of medical equipment from the U.S. into Nicaragua over the past three years is estimated at $8.3 million for 1997, $8.8 million for 1998 and $l0.0 million in 1999.

Nigeria

General Market Condition: No Restrictions

Source: Report from CS Post (via E-Mail), 2 May 2000

Are there special restrictions or tariffs that apply to used 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 devices?

Yes

Best prospects?

Scanners, diagnostic equipment, medical disposables and ECG equipment.

Source: IMI Medical, 9 March 2000

Summary

Nigeria still depends on imports for most of its medical equipment needs. Local production is limited to peripheral items such as hospital beds and gurneys.

The Nigerian year 2000 budget is yet to be released, therefore this report is hinged on projections for 1999 which to the best of our knowledge is still very relevant. The Government of Nigeria will spend an estimated US$ 125 million on hospital equipment this fiscal year. It also restated its commitment to the resuscitation of the nation’s health care delivery system through systematic funding and mobilization in line with the Bamako Initiative Program, a series of reforms in response to the deterioration of public health systems in developing countries. As in the previous years, private sector participation continues to account for much of Nigeria’s imports in 1998, valued at approximately US$ 400 million.

The 1998 - 2000 national rolling plan objectives also include the completion of teaching hospital projects at Ahmadu Bello University, Zaria, University of Nigeria, Nsukka, and Ado Bayero University, Kano, rehabilitation of Ibadan University teaching hospital and equipment of several medical health centers and primary health care centers.

There is no doubt that the political situation and the resultant economic crunch had some negative effects on imports. However, with the change in government and possible political and economic reforms, this sector promises strong growth rates with an increasing demand for equipment such as analytical and examination instruments, ultra sound scans, anesthesia equipment, mortuary and laboratory equipment.

Nigeria’s health policy is centered on primary health care delivered through an estimated 15,500 health institutions. The caption ‘Health For All By The Year 2000’, still remains the cornerstone of the Nigerian health care sector and therefore health care delivery is still high on the Nigerian government priority list. A number of projects are funded by the world bank under different loan agreements, especially for the rural areas.

The purchasing power of most Nigerian end-users is waning owing to devaluation of the national currency, and the widening gap between new technologies and developing economies. Refurbished and used equipment are therefore in high demand. A significant segment of this market in Nigeria is dominated by imports from Europe. However, U.S. Suppliers stand a good chance of competing successfully because Nigerians like U.S. equipment.

For further details, interested U.S. firms should contact the Commercial Service at the U.S. Embassy, Lagos, at the mailing address below:

The Commercial Service

U.S. Embassy, Lagos
Department Of State
Washington, DC 20521-8300

Tel. Number In Nigeria: 234–1-2610241

Fax Number In Nigeria: 234-1-2619856

Source: Report from CS Post (via Cable), 2 October 1998

There are no regulations for importation of used equipment in Nigeria. Official guidelines relating to import duties, use of letter of credit for payment of imports and containerization of imports valued more than US$ 1,000 apply to both used and new equipment.

Import duties on used equipment are the same as for new. Duties are determined by the Nigerian customs service based on the invoiced value of equipment and an import duty report (IDR) issued by a government-appointed inspection agent.

Like several other imports, used equipment is often imported into Nigeria overland through third countries and ports, and as accompanied luggage of air travelers. Currently Nigeria’s market for used equipment is dominated by imports from Germany, the Netherlands, Belgium, and the United Kingdom.

Price is the single most important driver of imports in this sector of the Nigerian market. Several local firms interested in used U.S.-origin equipment and parts including vehicles complain of high cost of importation from the United States, which according to them often results in an uncompetitive pricing strategy. Nigeria is a growth market for U.S.-origin products and services, but requires patience, resilience, a long-term relationship with a local partner (not a customer) and an export-cost strategy that recognizes Nigeria’s large population but low per-capita income.