Import Regulations for Pre-Owned (Used and Refurbished) Medical Devices -Chile - Customs Forum

**admin** · 07-22-2011, 00:35 AM

General Market Condition: No Restrictions, but Public Institutions Do Not Buy
Import Regulations For Used Medical Equipment
Trade Barriers
Chile generally has few barriers to imports or investment. Foreign firms operating in Chile enjoy the same protection and operate under the same conditions as local firms. The Chilean tariff rate for 2001 is currently eight percent on nearly all products from most countries, although many products from countries with which Chile has trade agreements enter with lower or no duties. Duties on capital goods purchased for use in export production may be deferred for a period of seven years and waived under some circumstances. Imports are subject to the same 18-percent Value Added Tax (VAT) as are domestic goods.
Customs Valuation
Chilean customs valuation uses the normal value of merchandise, without special discounts, plus freight and insurance (CIF). Used goods are valued by customs according to the current new value of similar merchandise, estimates the actual value of the equipment, based primarily on depreciation tables. The normal 8 percent duty will be applied plus an extra charge for used equipment of 4 percent. All imports are subject to the 18-percent Value Added Tax (VAT).
Pre-Owned (Used and Refurbished Medical Devices)
There are no restrictions/prohibitions to import used/reconditioned medical equipment/devices into Chile. However, internal regulations of public health institutions and lending banks may require that new equipment be purchased. Large private clinics in Chile prefer to buy new equipment and occasionally will purchase used equipment as long as it does not endanger the life of a patient, ie electrical beds, etc.
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.
Sanitary Code
Chile's Ministry of Health amended the Sanitary Code in March of 1997 to authorize the Institute of Public Health (ISP) to regulate medical devices.
These regulations classify medical devices, the same way it is done in the United States by the FDA, with three classes based on risk to the patient. This new system requires that devices have to be tested for quality by a Chilean authorized testing facility and to receive from ISP a Certificate of Quality before they can be sold in Chile. Devices must have an ISP approval seal on their labels.

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