07-23-2011, 17:57 PM
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Administrator
Join Date: Jun 2009
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Peru Import Regulations for Pre-Owned (Used and Refurbished) Medical Devices
General Market Condition: Restricted in Practice not Law
There is no explicit restriction on the importation of used/refurbished medical equipment into Peru. However, as a matter of practice over recent years, the Directorate General of Pharmaceuticals, Inputs and Drugs ( Dirección General de Medicamentos, Insumos y Drogas —DIGEMID) of the Ministry of Health is not authorizing the import of used medical equipment and devices.
By law, public health hospitals, social security hospitals and armed forces hospitals can buy only new medical equipment and devices. Private sector clinics and hospitals can purchase used medical equipment.
Imports of general used equipment are treated the same as imports of new equipment. Under General Health Law No. 26842, imports of medical equipment and devices require a 'Sanitary Registration' issued by DIGEMID of the Ministry of Health. It is necessary to obtain the Certificate to Foreign Governmen' from the US Food and Drug Administration (FDA) to be able to get the Sanitary Registration. The inspection certificate issued by one of the three authorized companies, ie, SGS, COTECNA, and Bureau Veritas, is also required. These companies charge US $250 for imports valued from $2,000 to $25,000 and 1 percent for imports valued overr US $25,000.
Both new and used products pay 7-percent or 12-percent custom duties applicable on the CIF value, in addition to the 18-percent sales tax.
In addition, the Customs Circular 1071 dated September 16, 1999, states that the Sanitary Registration is mandatory to release the products from customs. However, as a matter of practice DIGEMID only issues the Sanitary Registration for new medical equipment. The latter circular only authorizes the import of used medical equipment when it is for the immediate use by a professional returning to Peru.
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