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You might take a look at DIAN'S site in as much as they regulate importations as well as otherthings. Since EPSs and IPSs were created the demand took off.

www.dian.gov.co Unless your Spanish is up to it, this is the site from hell. You might try calling themin Bogot

Most Colombian end-users of medical equipment prefer state-of-the-art products and technologies.One of my wife's nieces is married to a man that manages Johnson and Johnson's Colombiaoperation. He said this may help:

Resolution No. 0434, issued by the Ministry of Social Protection on March 27, 2001.

The import authorization of used medical equipment is restricted to that classified as Class I (Lowrisk biomedical equipment and devices) or Class IIA (Medium risk biomedical equipment anddevices) in attachment 2 of the above mentioned resolution (See list below).

The authorization is subject to:

The issuance of a favorable Technical Concept issued by the Ministry of Social Protection

The approval of the end-users justification. As justification, the end-user must submit a projectdescription, specifying the benefits, services to be rendered, budget, costs, financing, and projectviability in the medium term.

Submission of a document issued by the manufacturer or its representative, certifying that theequipment was manufactured less than 4 years before the import date and the current optimalperformance of the equipment and its security system.

The manufacturers or importers capacity to provide after sales services on the equipment. Themanufacturer/importer must have the proper human, physical, material, and technological resourcesto provide the service and to be responsible for maintaining guaranteed equipments performancestandards without endangering operators and patients health and safety.

Medical equipment and devices classified as Class I - Low Risk:

All non-invasive products for direct contact with injured skin that are used as mechanical barriers forthe compression or absorption of exudates.

Invasive products for body orifices, except invasive surgery products that are not for connection toan active sanitary product, if used temporarily.

Invasive products for body orifices, except invasive surgery products that are not for connection toan active medical device, if used in the oral cavity down to the pharynx, in the outer ear up totympanum, or in the nasal cavity.

http://www.dian.gov.co/http://www.dian.gov.co/

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All invasive surgery type products for temporary use that are reusable surgical instruments.

Medical equipment and devices classified as Class IIA - Medium Risk:

Non-invasive products for the conduction or storage of blood, fluids or body tissues, liquids or gasesfor perfusion, administration, or introduction in the body are included in this classification if (a) Ifthey can be connected to an active sanitary product classified under class II or above, or (b) if theyare to be used for the storage or channeling of blood or other fluids, or for the storage of organs,parts of organs, or body tissues.

Non-invasive products used for modifying the biological or chemical composition of blood or otherbody fluids, or of other liquids to be introduced in the body when the treatment consists of gas orheath filtration, centrifugation, or exchange.

Non-invasive products that are not included in Class I and IIB, including the products used mainly toact in the wound microenvironment.

Invasive products for body orifices, except invasive-surgical-type products that are not to be usedconnected to an active sanitary product, if they are for short term use.

Invasive products for the body orifices, except invasive-surgical-type products that are not to beused connected to an active sanitary product, if they are used in the oral cavity down to thepharynx, in the external ear up to the tympanum, or in the nasal cavity, and which cannot beabsorbed by the mucous membrane.

Invasive products for body orifices, except surgical-type invasive products that are to be usedconnected to an active sanitary product of the class IIA or any superior class.

Invasive surgical-type products for temporary use will be classified under class IIA, unless otherwisespecified.

Invasive surgical-type products to be used for a short term will be classified under class IIA exceptfor the exemptions listed in the definition of the other classes.

Implants and invasive surgical-type products for prolonged use to be implanted inside the teeth.

Active therapeutic products for energy administration or exchange will be included in class IIAunless they are considered under other classes.

Active products for diagnosis will be included in class IIA if: (a) they are to be used foradministration of energy to be absorbed by the human body. Products whose purpose is toilluminate the patients organism in the visible spectrum are excluded. (b) they are to be used for the

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creation of an image of radio-active pharmaceuticals distributed in vivo. (c) they are to be used toallow a direct diagnosis or the surveillance of vital physiological processes.

Non active products to be used specifically for registering diagnostic radiographic images.

Active products to be used for the administration or extraction of medications, body liquids or othersubstances to or from the organism will be included in Class IIA. If the procedure is performed in apotentially dangerous manner, considering the nature of the substances, the part of the body andthe method of application, they will be included in Class IIB.