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<\/span><\/li><\/ul><\/div><\/div><\/div><\/div><\/div><\/div>Regulation of Services in Argentina<\/h1>\n
Manufacturers of medical products wishing to register their products in Argentina must comply with the requirements of the National Administration of Medicines, Foods and Medical Technology – ANMAT<\/a>.<\/p>\n
Medical products must be registered by a company located in Argentina and authorized by ANMAT as Importer of Medical Products. According to Argentine regulations, it is preferable for registration that the manufacturer has a Free Sale Certificate from a country with high sanitary surveillance. Otherwise, ANMAT must inspect the manufacturer’s plant at the source.<\/p>\n
We offer the following services in Argentina:<\/h2>\n<\/div>
<\/i><\/i><\/span>Initial Registration of Medical Devices<\/span><\/a><\/h4><\/div>
\nThe registration includes the preparation, submission and follow-up of the files to be sent to ANMAT and their technical evaluation. Response to all ANMAT’s necessary demands. If necessary, translations can be included.<\/p>\n<\/div><\/div><\/div>
<\/i><\/i><\/span>Local Representation<\/span><\/a><\/h4><\/div>
\nHosting of registration in our associated company authorized by ANMAT (Registration Holder)<\/p>\n<\/div><\/div><\/div>
<\/i><\/i><\/span>Registration maintenance (Registration Holder)<\/span><\/a><\/h4><\/div>
\nMaintenance and annual updating of registration in accordance with the manufacturer’s requirements.<\/p>\n<\/div><\/div><\/div>
<\/i><\/i><\/span>Audits<\/span><\/a><\/h4><\/div>
\nAudits at commercial distributors meeting the specifications of the product manufacturer, audits of Good Manufacturing and Distribution Practices or audits in accordance with ISO 13485.<\/p>\n<\/div><\/div><\/div>
<\/i><\/i><\/span>Regulatory Consulting<\/span><\/a><\/h4><\/div>
\nAdvice on regulatory issues for medical products that can be marketed in Argentina.<\/p>\n<\/div><\/div><\/div>
<\/i><\/i><\/span>Market Research<\/span><\/a><\/h4><\/div>
\nInvestigation of competing products, as well as verification of adverse events and recalls.<\/p>\n<\/div><\/div><\/div>
<\/i><\/i><\/span>Technical Assistance for Product Testing<\/span><\/a><\/h4><\/div>
\nAdvice on carrying out tests on medical products, as well as preparing validation reports.<\/p>\n<\/div><\/div><\/div><\/div><\/div>
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