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Health
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Medical
Device Regulatory
Requirements for
Peru
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Updated: 7/19/2000. Updates reflect that IPSS changed its name to ESSALUD; for government purchases the importer must no longer be registered with the Ministry of Health; Certificate to Foreign Government from the U.S. FDA should accompany medical device registration submissions; government purchases exceeding $100,000 - up from $75K - require government tenders; and most of the contact phone and fax numbers have changed. (Valerie Barth)
Disclaimer: The information contained on this website is derived from public sources and is current to the best of our knowledge. For detailed and definitive information about a country's laws and policies, the government of the country concerned should be consulted. Regulatory
Agency The Ministry of Health, DIGEMID (Direccion General de Medicamentos, Insumos y Drogas) is the regulatory agency for the health care sector. The laws regulating the registration requirements for medical devices were enacted in the Health Law of December 1997. In Peru, health care is provided by both the public and the private sector. The public sector health services providers are the Ministry of Health (MOH), the Social Security Service (ESSALUD) and the Armed Forces hospitals. Private sector providers include profit hospitals and clinics, and non-profit hospitals and clinics. About 75 percent of existing patients are cared for by public institutions. Regulations Imported medical equipment and supplies must comply with certain regulations, and sanitary requirements. First, the importer/dealer's firm must be legally registered and have the "Registro Unificado de Contribuciones (RUC)" for tax purposes. For purchases made by the government, it is no longer required to be registered in the "Registry of Importers at the Ministry of Health. Medical equipment, supplies, and pharmaceutical products require a "Registro Sanitario" (sanitary registry) to register the goods and products in the DIGEMID at the Ministry of Health. This registry is mandatory for most of the medical equipment and supplies. The registration must be obtained before the equipment and/or product is imported. The importer must fill out the sanitary registry form provided by DIGEMID and include the following documents: a) Certificate
to Foreign Government issued in the country of origin. Both medical
equipment and pharmaceutical products require this certificate. The
valid document, in lieu of the certificate of origin is issued by the
Food and Drug Administration. The free sale certificate should state
that the product is freely sold and marketed in the U.S. according to
the norms and regulations of the United States. b) Letter
from the manufacturer stating that the equipment, supplies and pharmaceutical
products are manufactured and/or produced by the U.S. company. This
letter should provide the product description, the basic technical information
and attach a< copy of the catalog. c) Quality
Certificate: a certification from the producer stating that the product
meets international standards of quality such as the UL or BSI. This
certificate is not required in all the cases. d) A Protocol
Analysis. This analysis should indicate the percentage of each chemical
element, component of the product, the lot, and manufacturing and expiration
dates of the product. It should also include the project of the medicine
(this could either be a physical presentation or the design of the product).
Prescriptions must be in Spanish language. All these
documents must be notarized and signed by the Peruvian Consul. The sanitary
approval will be provided by DIGEMID in approximately 15-20 days. The
cost of each registry is approximately US$100 per type of equipment
and pharmaceutical product. Other certifications
required when bidding to government tenders are: a) Representation
Agreement, where the manufacturer indicates that the importer is their
representative in the country. The agreement must be legalized by a
Peruvian Consulate in the U.S. and registered in the Foreign Affairs
Ministry. b) Biosecurity
standards, electrical standards and the environmental standard that
the product meets are required by the Ministry of Health for its public
tenders. Import Duties and Taxes Tariffs
on medical equipment include an ad-valorem custom duty of 12 percent
and an 18 percent value added tax (IGV). Pre-shipment Inspection In addition,
all imports of $5,000 or more are subject to pre-shipment inspection
services with the exception of motor vehicles. The following three companies
have been selected by the government to provide the inspections services:
Societe Generale de Surveillance S.A., Cotecna Inspection S.A., and
Bureau Veritas (BIVAC). Charges for pre-shipment inspection services
are as follows: (a) for imports from US $5,000 to US$25,000: US$250,
(b) for imports above $25,000 the charge: 1 percent of FOB value. Distribution Generally,
foreign manufacturers have a local representative. The representative
can be exclusive or non-exclusive. Some dealers sell several lines of
equipment and some offer after-sale service while others do not. Manufacturers
should be cautious in choosing their local representatives. The government
only buys products from duly accredited local representatives. The representative
(the importer or dealer) is no longer required to be registered in the
Registry of Importers. Public
sector purchases must be carried out in accordance with Government Procurement
Regulations (Reglamento Unico de Adquisiciones and the budget of each
agency. Purchases
by the public sector exceeding US$100,000 must be made through public
tenders or selective invitations to bid. Foreign firms who wish to bid
must appoint a local representative with a Representation Agreement.
Purchases
by the Ministry of Health are made by each project. ESSALUD mostly buys
centrally through its procurement office. However, a small portion of
supplies are bought directly by the health care centers and hospitals.
Purchases
made by private firms or individuals are bought directly for the importer
from his stock of equipment, or imported from the manufacturer through
the representative. Contact Information Government
Agencies Health
Service Stregthening Program Ministerio
de Salud Seguro
Social ESSALUD Seguro
Social ESSALUD Direccion
General de Medicamentos, Insumos y Drogas (DIGEMID) Trade Associations
Asociacion
de Clinicas y Hospitales Comite
de Importadores de Equipo Medico
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Last updated on 5-2-05 by JF
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