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Medical Device Regulatory
Requirements for
Venezuela

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 Office of Registration and Control for Medical and Paramedical Equipment and Supplies (OICEMP) of the Ministry of Health is charged with regulating medical device imports into Venezuela.

Regulations

All medical equipment, apparatus, systems, etc., whether imported or locally manufactured, must be registered with the Ministry of Health's Office of Registration and Control for Medical and Paramedical Equipment and Supplies. Currently, the Venezuelan Ministry of Health is establishing an audit and control infrastructure with the Venezuelan Customs to inspect the equipment's origin and specifications before it can actually be sold in the local market. This means that two years form now all imported medical equipment and supplies including disposable items will have to undergo a strict control in customs before it can be registered by the Ministry of Health.

Registration

The law for medical devices was enacted in February 1996, however it is currently not fully enforced. The registration of medical devices requires the following information:

a) Certificate to Foreign Government

b) Letter of Authorization

c) Final Product Drawings

d) List of Components/Materials

e) Maufacturing Location

f) Manufacturing Method

g) Labels/Directions for Use

h) Pakaging Materials

i) Quality Control Test Methods/Records

j) Stability Studies/Certificate

k) Clinical Publications

l) Product Brochure (Catalog Page)

Standards

All written material including catalogs, price lists, and instructions should be in Spanish. Failure to provide this may disqualify a supplier from the equipment selection process.

Distribution

All business entities, whether they be manufacturers, distributors/agents or service companies, must register with this office. Proof of registry is also required for all official bidding on government tenders. This should be done through the Health Ministry's "Oficina de Inscription y Control de Equipos y Material".

Public sector purchases are required by law to be through duly registered suppliers and authorized representatives. Calls for public bids as well as the pre-selection notice, are published in local news media. However, the opening of bid envelopes and the selection of suppliers, although expressly stated to be open to the public, is seldom published.

The private sector frequently buys directly from the supplier or manufacturer. This market is made up of a large number of importers/distributors/agents, as well as subsidiaries or affiliates of many foreign manufacturers. Most are members of AVEDEM.

Contact Information

Government Agencies

Ministerio de Sanidad y Asistencia Social (MSAS)

Proyecto Salud

Torre Sur, Piso 8, Centro Simon Bolivar

Caracas 1010, Venezuela

Phone: (011) (582) 483-4209/481-4292

Fax: (011) (582) 481-6371

Contact: Dr. Luis Fuenmayor, Project's Director

Ministerio de Sanidad y AsistenciaSocial

Oficina de Inscripcion y Control de Equipos y Material

Medico-Paramedico "OICEMP"

Torre Sur, Piso 8, Oficina 821

Centro Simon Bolivar

Caracas 1010, Venezuela

Phone: (011) (582) 41-15-63

Fax: (011) (582) 483-4219


Instituto Venezolano de Los Seguros Sociales (IVSS

Edificio Haieck

Calle los Perez, Quinta Crespo

Caracas, Venezuela

Phone: (011) (582) 483-2367

Contact: Dr. President


Fundacion para el Mantenimiento de la Infraestructura Medico-Asistencia para la

Salud Publica (FIMA)

Edificio Profesional Baralt, Piso 9

Carmen a Bucare, Av. Baralt

Caracas 1010, Venezuela

Phone: (011) (582) 482-0966 / 482-1968 / 482-8020

Fax: (011) (582) 482-5403

 

Trade Associations

Asociacion Venezolana de Distribuidores de Equipos Medicos, Odontologicos, de Laboratorios y Afines (AVEDEM)

Avenida Francisco de Miranda

Edificio Centro Seguros La Paz, Piso 4, Ofic. Norte

41-A. La California Norte

Caracas 1070, Venezuela

Phone: (011) (582) 237-3986 / 239-4873

Fax: (011) (582) 237-2923

Contact: Eleazar Colmenares, President

 

Last updated on 5-2-05 by JF

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