DEVICE REGULATION & THE HARMONIZATION PROCESS IN LATIN AMERICA

Atualizado: Jul 16

There are 23 countries in Latin America(Argentina, Belize, Bolivia, Brazil, the Caribbean [Antilles], Chile, Colombia, Costa Rica, Cuba, Ecuador, El Salvador, French Guiana, Guatemala, Guyana, Honduras, Mexico, Nicaragua, Panama, Paraguay, Peru, Suriname, Uruguay and Venezuela) with a total population of approximately 517 million people. The main language in this region is Spanish, although Brazil – with a consumer market of 100 million people – speaks Portuguese.


UNDERSTAND THE LATIN AMERICA REGION


Latin America is an important region for the medical devices consumer market, particularly with regard to imported products as there are few local industries working with cutting-edge technology, particularly taking into account the proportion of the population in the region.





It is worthwhile stressing that a company wishing to sell a medical device in Latin America must obtain marketing authorization for its product in each country, in compliance with local procedures and documentation.


THE DOCUMENTATION


The procedures and documentation for regulating medical devices vary from one country to another. This means that a company wishing to sell medical devices in Latin America should be fully familiar with local laws in order to bring the authorization procedures for its product to a successful conclusion within a reasonable length of time.


Familiarity with local culture is another important tool for understanding the regulations in a given country. Frequently, gaps in this understanding result in delays in gaining regulatory approval for medical devices in the Latin American countries. This is why special care is urged for companies interested in this region in terms of complying with the laws of each country as well as noting political and cultural aspects. Ideally, the company should build up a regulatory team with local representatives able to respond efficiently to the demand for each country, particularly in terms of dossier preparation.


Experience has shown that many of the problems occurring during the authorization of medical devices in the Latin American countries are due to a lack of familiarity with local laws. It is not uncommon to see companies submitting their products for registration based on the documentation stipulated by regulatory agencies in other countries such as the US Food and Drug Administration (FDA), almost completely ignoring local requirements established through specific laws.


PRODUCT CLASSIFICATION


Product classification criteria are other crucial factors to consider when authorising medical equipment. For instance, one Latin American country may exempt a medical device from registration and consequently not require the presentation of much technical informationon the product in order to authorize it. However, another country in the region may handle the same product quite differently as it may lack the same scientific experience or understanding, and may consequently require the product to be registered, backed up by a series of scientific documents on the technology used, in order to ensure its quality, safety and effectiveness. Consequently, a product may be classified differently among the various countries in the region.


Nevertheless, it is noted that even today, many companies are still exporting medical devices to the Latin American countries before gaining authorizationfrom the local authorities, and are quite unaware of local regulations and specific authorization requirements. Familiarity with the laws of each country in the region should consequently be rated as a crucial factor for successful sales of medical devices and should in fact form an integral part of corporate business plans, in order to avoid the risk of losses while ensuring success with the business as a whole.


HARMONIZATION PROCESS


Many of the countries in Latin America have signed the Agreement on the Application of Sanitary and Phytosanitary Measures (for food) resulting from the General Agreement on Tariffs and Trade, and prompting massive efforts to harmonize local legislation with that of the other members of the World Trade Organisation (WTO). However, the participation of manyof these countries in discussion forums such as the Global Harmonization Task Force have not resulted in any specific document being signed by the Latin American countries to ensure uniform understanding and reciprocal actions, particularly with regard to a specific single format for the dossier filed to register medical devices in the many different countries in this region.


Accordingly, the process of harmonizing regulationsand construing procedures has been followed in a far more individual manner by each country in Latin America rather than as a regional bloc, meaning that the results have shown that as international discussions progress in this sector, the trend is for each country to fine-tune its legislation individually, adapting it to understandings that are internationally accepted although without such understandings being reciprocal and uniform with the decisions taken by the countries in the region.

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