A medical device is a product intended for health such as a piece of equipment, an apparatus, a material, an article or system for medical, dental or laboratory use, for prevention, diagnose, treatment, rehabilitation or contraception purposes, which does not use a pharmacological, immunologic or metabolic means to perform its main function in human beings and whose function can be aided by such means.

In order to obtain the relevant authorization, prior to the donation shipment, the recipient shall submit to the ANMAT Office of Medical Devices, situated on 869 Mayo Av. 5 floor, City of Buenos Aires (tecmed@anmat.gov.ar), a detailed list of the products to be donated, as per instructions herein.

The recipient shall not sign the donation letter of acceptance until this Agency has approved the donation. Otherwise, the recipient shall be responsible for re-exporting the products on their own expense.

Once ANMAT has approved the donation, the recipient shall be able to send a letter of acceptance to the donor and shall submit to the Office of Medical Devices the application for the donated products import authorization.
By means of such application, the recipient shall accept the responsibility for the donated medical devices and undertake the explicit commitment of affording the re-exportation costs, should ANMAT find the products unsuitable for human use.

Medical products should not be shipped along with other type of products.

Even though donors are well-intentioned and wish to cooperate with our country needs, they should not send any donation without a making previous consultation and coordinating with ANMAT Office of Medical Devices, in order to avoid inconveniences or unnecessary expenses, as non-compliant products shall not enter our country. Moreover, as the destruction of any element (even donations) arrived in Argentina is strictly forbidden by environmental protection acts, non-compliant products shall be re-exported to the origin country and expenses for such procedures shall be afforded by the donor or the recipient.

The following information shall be included in the submission in a clear manner:

It shall be explicitly stated whether the electro-medical devices are new or refurbished.

In addition to the overall requirements above mentioned, the following data must be mandatorily stated:

a) In the case of implants (pacemakers, vascular prostheses, etc.) and sterile items (syringes, needles, surgical gloves, etc.).

TAll these products must be in their primary containers which must be hermetic and intact and sterility must be preserved.

By no means shall the income of products whose primary packaging was opened or made useless be authorized. Neither shall products that were recalled from market by their manufacturer be authorized.

It must be considered that Argentine regulations prohibit the reuse of single-use medical devices and therefore no donations of disposable medical devices which are used or expired and intended for re-sterilization shall be authorized, pursuant to Regulation 255/94 of the Ministry of Health.

Neither shall be authorized the income of single-use medical devices intended to be sterile, bulk or packaged unsterilized. All the products shall be in their original container and sterilized.

b) Non-sterile disposable items (colostomy bags, etc.)

c) Medical equipment

d) Instruments for surgical and dental use, among others:

e) Absorbent products (baby and adult diapers, body fluids absorbents, etc)

h) Disinfectant and sanitizing products for medical instruments

In all cases, products are required to be adequately packed and protected from possible adverse weather and environmental conditions during transportation and storage.

Note: the requirements laid down hereby are only those of this Agency. Other Customs requirements should be met as well.