Medical device regulations tend to vary substantially from region to region as virtually every country has its own set of rules that manufacturers must comply with in order to bring a device to market. These regulations are generally quite complex, but such complexity is necessary to ensure safety and effectiveness of devices intended for human use. This article provides a general overview of the current medical device regulations in Argentina.
Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT) is the institution responsible for regulating medical devices in Argentina. ANMAT uses a risk-based classification system and, similarly to the European Union and Canada, classifies medical devices into four classes depending on their potential risk (i.e. Class I – lowest risk; Class IV – highest risk).
As of May 1, 2006, the registration process for medical devices and pharmaceuticals in Argentina is unified with that of the other Mercosur countries. Mercosur was established in 1991 to promote free trade and the circulation of goods, people, and financial assets between the following coalition members: Argentina, Brazil, Paraguay, and Uruguay. Associate countries include Bolivia, Chile, Colombia, Ecuador, Guyana, Peru, and Suriname.
There are currently ten harmonized medical device resolutions for Mercosur countries, including procedures for GMP certification, the training of inspectors, premarket approval, the safety and efficacy of medical devices, and the exchange of information regarding inspection dossiers and incidents leading to death or serious health detoriations. Below you will find most important information on the registration process of medical devices in Argentina.
1) Resolution 3802/2004 is one of the most crucial documents for the medical device market and has managed to unify many previous resolutions. These resolutions include the establishment of ANMAT as the institution responsible for regulating medical devices, conformity with the Mercosur Technical Regulation for Registration of Manufacturers and Importers of Medical Devices, regulations for dental devices, and the designation of requirements towards label descriptions.
2) Product Registration
In order to register a product, the manufacturer must have an office or distributor registered with the Ministry of Health in Argentina. For Class III and IV medical devices, manufacturers must submit results from clinical trials proving the safety and effectiveness of the device. It is also required that Good Manufacturing Practice (GMP) standards are met and that the device is compliant with Disposition 4306/99. The manufacturer or importer is obligated to conduct postmarket surveillance activities and thoroughly document all activities. Applicants must also provide a full history of previous commercialization of the device in other countries.
Manufacturers must prepare technical documentation regarding their device and include the following information along with the application:
- Identification information for the manufacturer/importer and the medical device (detailed in Annex IIIA, IIIB, and IIIC of Disposition 2318/02)
- For imported medical devices, Certificate of Free Sale (CFS) from a competent authority
This document must contain the name of the manufacturer and provide specific information on the medical device and its accessories.
- A document from the manufacturer or importer giving consent to introduce the product to the market
- Declaration of payment for the product registration fee
- Declaration of conformity with Mercosur regulations
The information above applies only to Class II, III and IV medical devices. For Class I devices, manufacturers must only provide the declaration of payment, manufacturer/importer identification information, and declaration of compliance with Mercosur legislation.
All documents must be translated to Spanish. The review time is set to 180 days. If the device is approved, its registration is valid for 5 years.
All medical device labels must contain the product description, information on how the product should be stored, product expiration date (if applicable), and information about the importer, including the address of the importing company. As with the documents that must be submitted for product registration, all labels must be in Spanish.
4) Importation duties and taxes
Because Argentina belongs to the Latin America trade bloc, Mercosur, all imported medical devices are taxed according to the Mercosur Common External Tariff (AEC). This tariff designates the tax rate, which may range from 0% to 16%. In the case of importing refurbished medical devices, the tax rate ranges from 0% to 24%. When a product is purchased, there is a value-added tax (VAT) equal to 10.5% for new medical devices and 21% for all used or refurbished devices. VAT values are dependent on Cost, Insurance, and Freight (CIF) value.
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