Global Import Regulations for

Australia

General Market Condition: No Restrictions

Source: Report from CS Post (via E-Mail), 17 April 2003

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

There are no specific tariffs that apply to used or refurbished medical equipment that do not apply to new medical equipment.

Any used or refurbished medical equipment must comply with the same regulations that apply to new medical equipment. This includes any relevant Australian standards and listing or registration with the Therapeutic Goods Administration (TGA). For information on medical regulations and the TGA, contact:

The Information Officer, Conformity Assessment Branch Therapeutic Goods Administration PO Box 100 Woden ACT 2606 Australia

Tel: [phone] Fax: [phone] Email: [e-mail] Website: www.health.gov.au/tga

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?

A third party cannot legally import the same device in used/refurbished condition without the device being subject to new listing or registration with the TGA because the TGA will have only approved the device for the original sponsor of the product. The third party will have to apply to the TGA for listing or registration of the used/refurbished device in Australia.

Can public health institutions buy used or refurbished medical devices?

Health institutions are able to purchase used/refurbished medical equipment with no restrictions. Preference is given to products that come with quality assurance and warranties. Suppliers of used/refurbished medical equipment are more likely to distribute products for which there are available spare parts.

However, since the Australian market for medical devices is mature and consumers are sophisticated, there is little demand for technologically obsolete devices. It appears that much of the supply of used equipment is being met by local health institutions with only a small amount being imported. Therefore, there has been little or no increase in suppliers or market for used equipment over the past few years. Major teaching hospitals are unlikely to expose themselves to the increased risk of purchasing used goods. Given the current strength of the U.S. dollar, the economic viability of importing used equipment of suitable quality into Australia is considered questionable at this time.

Is there a market for used or refurbished medical devices?

Demand for used medical equipment is limited. There is technically a market for used or recycled equipment. However, this is not considered a promising sector because hospitals and hospital groups often sell used equipment among themselves. The equipment moves down the ‘food chain’ from major hospitals to small private hospitals and out-patient clinics.

Technical advances and the desire to have the latest and best equipment, even in small hospitals, is making used equipment redundant. An export market of used equipment is developing with Australian distributors exporting to Asia, the Pacific Islands and Papua New Guinea. In addition, some equipment is being exported to overseas locations through church groups and organizations such as Rotary International.

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

The market for used or refurbished medical equipment in Australia is small, with limited prospects for U.S. suppliers. Best prospects lie in the low-technology sector of the market such as furniture (for example, beds), wheelchairs, and rehabilitation equipment.

Austria

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

See also entry for the European Union.

Source: Report from CS Post (via Cable), October 22, 1998

There are no restrictions on the import of used equipment per se in Austria. All imports of used equipment are treated the same as new. This means that they carry the same duty and are required to be tested and marked with the European ‘CE’ mark before being installed.

[This cable generally addresses manufacturing and agricultural equipment; applicability of these comments to medical equipment is uncertain.]

Bahamas

General Market Condition: No Restrictions, but Public Institutions Do Not Buy

Source: Report from CS Post (via Cable), 4 April 2001

The Bahamas Ministry of Health provided the following information in response to questions regarding the importation of used medical equipment.

The Government of the Bahamas applies the same restrictions to both used and new medical equipment. (Importation of new or used medical equipment is subject to a 42 percent customs duty.)

It is not a policy of the Ministry of Health to purchase used and/or refurbished medical equipment, implements, or devices. Bahamian public and private sector health institutions prefer to purchase new equipment.

Bangladesh

General Market Condition: Restricted

Source: Report from CS Post (via E-Mail), 15 April 2002

The Government of Bangladesh imposes restrictions on the import of some used medical equipment. Second-hand and reconditioned machines, which would include medical products such as used X-ray machines, must be imported with a certificate from an established international inspection firm attesting that the equipment will last at least 10 years.

There are no special tariffs that apply to used or refurbished medical equipment. Customs valuation of the equipment is normally taken from the invoice presented by the importer.

The prospects in Bangladesh for American origin used medical equipment are good. There is a particular demand for dental chairs with drill systems, X-ray equipment, ultrasound machines, magnetic resonance and CT-scan equipment, and electrocardiographs. Private clinics and independent doctors have purchased used equipment, but have had difficulty locating local suppliers. Hospitals in the public sector, however, generally purchase new equipment.