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Medical Device Regulatory
Requirements for
Peru

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
Av. Salaverry, cdra. 8, Piso 2
Jesus Maria
Lima 11, Peru
Phone: (51-1) 315-6600 ext.2408
Fax: (51-1) 315-6600 ext. 2409
Contact: Dr. Augusto Melloni, Director General

Ministerio de Salud
Av. Salaverry, cdra. 8, Piso 2
Jesus Maria
Lima 11, Peru
Phone: (51-1) 315-6600 ext. 2406
Fax: (51-1) 423-0838
Contact: Dr. Giovanni Escalante, Consultor del Proyecto Generacion de Capacidades

Seguro Social ESSALUD
Domingo Cueto 120, 8vo. Piso
Jesus Maria
Lima 11, Peru
Phone: (51-1) 471-2824
Fax: (51-1) 471-2638
Contact: Dr. Carlos French Irigoyen, Gerente Central de Salud

Seguro Social ESSALUD
Domingo Cueto 120, Edificio LIMA, 5to. Piso
Jesus Maria
Lima 11, Peru
Phone: (51-1) 265-6000, 265-7000 ext. 2579
Fax: (51-1) 265-7000
Contact: Ms. Susan Matos Zevallos, Gerente de Adquisiciones

Direccion General de Medicamentos, Insumos y Drogas (DIGEMID)
Ministerio de Salud
Av. Arenales 1302
Jesus Maria
Lima 11, Peru
Phone: (51-1) 265-8773
Fax: (51-1) 265-8778 ext. 237
Web: www.digemid.gov.pe
Contact: Dr. Luis Reategui, Director Ejecutivo

Trade Associations

Asociacion de Clinicas y Hospitales
Av. Dos de Mayo 1502, Of. 203
San Isidro
Lima 27, Peru
Phone: (511) 422-4024
Fax: (511) 441-9546
Contact: Dr. Arturo Vasi Paez, Gerente

Comite de Importadores de Equipo Medico
Camara de Comercio de Lima
Gregorio Escobedo 396
Jesus Maria
Lima 11, Peru
Phone: (51-1) 463-3434
Fax: (51-1) 463-2941
Contact: Julian Locket, Presidente


Last updated on 5-2-05 by JF

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