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REGULATIONS FOR IMPORT
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In 2006, Argentina has completed the unification with Mercosur
countries (Mercosur includes Argentina, Brazil, Chile, Paraguay
and Uruguay) as far as the registration for medical products
and importers is concerned. The authority for this matter
is the National Administration of Drugs, Food and Medical
Technology (ANMAT).
According to Mercosur Technical Regulations for Registration
of Medical Products, companies have to comply with Good Manufacturing
Processes (GMP) and importers have to register with ANMAT.
There are some additional regulations from the Standards Institute
of Argentina (IRAM) but they are voluntary.
ANMAT requires Spanish labeling with product description,
information on packaging, storage, lot number, expiration
date and importer's contact details. The National Administration
identifies products according to the Emergency Care Research
Institute (ECRI) nomenclature. ANMAT also assesses risk categories
from I to IV and has sanctions for violations.
Required documents for import may include a Certificate for
Free Sale (CFS), issued from the National Food and Drug Administration
or from the State Departement of Health. CFS states that the
product is sold and marketed according to national rules.
This document has to include the name of the manufacturer
providing specifications and models. If there is no sample
available, the company has to attach a letter from the manufacturer
with codes, models and accessories.
A required document may be the Protocol Analysis or Certificate
of Analysis, authored by the quality control division of the
manufacturer, reporting tests' results on the product. Usual
reported tests are on microbiological and chemical aspects,
skin sensitivity, human biocompatibility and sterilization
methods. The registration documents have to be submitted to
Argentine consulate or embassy. An operation manual with instructions
for each device is required, together with catalogues with
technical specifications and accessories list if available.
Used or refurbished medical equipment is allowed only with
a certificate by the original manufacturer or by the Commercial
Section of Argentine Embassy or Consulate. Foreign vendors
have to guarantee spare parts availability, after-sale service,
manuals and an agent based in Argentina. Used equipment may
not be older than 10 years. The import of used or refurbished
material are subject to tariff up to 24%. To import new medical
equipment to Argentina, it is necessary to pay Mercosur Common
External Tariff (AEC), which ranges form 0% to 16%.
According to the Capital Goods Act, the purchase of new equipment
is subject to 10.5% VAT, while the purchase of used or refurbished
equipment is subject to 21% VAT. Both payments are assessed
on CIF value.
For more information
about Argentina, please visit the following websites:
Mercosur website - www.mercosur.int
ANMAT website - www.anmat.gov.ar
IRAM website - www.iram.com.ar
ECRI website - www.ecri.org
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