The Protection of Personal Data is a fundamental right of citizens of inexcusable application by any type of organization, both public and private. In this sense, companies, professionals or any type of organization collect and process data from natural persons (clients, patients, employees, etc.) and, therefore, they are responsible for the security and protection of such data.
In this sense, after the approval of the New General Regulation of Data Protection (RGPD) – 2016 / 679- in the European Union in 2016, with its corresponding entry into force on May 25, 2018, which has repealed Directive 95/46 / EC, the rules of the game have changed not only for the EU countries and their institutions, both public and private, but the wave of updating of the national regulations on this issue has reached Latin America, specifically we refer to countries such as Argentina, Uruguay, Chile and Brazil.
In the case of Argentina, it recently submitted a bill to Congress that would replace the Personal Data Protection Law No. 25,326, which has been in force since 2000, in an attempt to align the country’s data protection standards. with the GDPR. The bill includes the requirements for notification …Read More
“Doubt, of whatever kind, can be ended by action alone.” (Thomas Carlyle, 1795-1881)
Manufacturers of healthcare products, mainly those located outside Latin America often doubt about how their products will be considered in this Region. This question is also frequently asked by manufacturers of medical devices, especially by the time a regional business strategy is being discussed. In this article, Moeller IP Advisors highlights some actions that will give an answer to this question.
Regional Background: The Regulation of Medical Devices in Latin America
The regulation of medical devices started in the Region in the mid 90âs as a result of reforms that were carried out in the Health Sector. It was at that time that the role of the state with regards to the regulation and protection of the health of the population became more relevant in comparison with former decades.
It is also important to keep in mind that, Latin America countries including the Caribbean area are essentially medical device importing countries. It is within this context, that the health authorities of each state must guarantee the quality, safety and efficacy of products for its population, notwithstanding if the products are manufactured locally or mostly imported into their …