Americas Medical Device Regulations

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The US FDA control has been long established and is one of the founder members of GHTF (currently known as IMDRF).

 

A working group has been formed in IMDRF since 2012, to strengthen the regulatory capacity for medical devices in the Region of the Americas. There are 14 countries including Canada, Argentina, Brazil, and Mexico (the major countries of penetration in North and Latin America). Pan American Health Organization (PAHO) became IMDRF Affiliate Organization in September 2014. This recognition facilitates the interaction between IMDRF and the countries from the Americas that are not members of IMDRF.

While the harmonization in progress, MERCOSUR (Mercado Comun del Sur or Common Market of the South), a free-trade political and economic agreement have been in place between Bolivia, Venezuela, Uruguay, Paraguay, Brazil, and Argentina.

 

Apart from the elimination of tariffs of the goods traded between countries, there is also a proposed system of harmonized medical device regulations. Each member country will have the same registration requirements, however, the medical device will require approval in each country. The goal is to have single approval to cover all member countries (similar to the EU CE mark). MERCOSUR quality standards, also known as Buenas Prácticas de Fabricación (BPF), will be issued following the manufacturing facility inspection.

 

Good communication in Spanish and Portuguese will facilitate the product, testing, and manufacturing audit approval in the stringent countries at present because of the country-specific requirements and testing by the local accredited certification bodies.

 

The ARQon team will help in the registration in the Americas region from Canada, US, to Latin America.