Brazil Medical Device Import Regulations

Brazil - Import Requirements and Documentation

https://www.trade.gov/country-commercial-guides/brazil-import-requirements-and-documentation

The entry of several imported products to Brazil is subject to permits issued by the respective Brazilian authorities that regulate the entry and commercialization of these goods. Goods that require an import license require approval from one or more of …

Brazil - Healthcare - International Trade Administration

https://www.trade.gov/country-commercial-guides/brazil-healthcare

Market Access of Medical Devices in Brazil - Johner …

https://www.johner-institute.com/articles/regulatory-affairs/and-more/authorization-of-medical-devices-in-brazil/

4. Prerequisites for the authorization of medical devices in Brazil. Before manufacturers can submit the authorization documents to the Brazilian authorities, they must fulfill some prerequisites: 1st prerequisite: the B …

Understanding Medical Device Regulation In Brazil

https://www.meddeviceonline.com/doc/understanding-medical-device-regulation-in-brazil-0001

Understanding Medical Device Regulation In Brazil. By Julio G. Martinez-Clark, CEO, bioaccess. Comprising 3.28 million square miles and 209 million citizens, Brazil is the world’s fifth-largest …

Brazil Medical Device Approval & ANVISA Registration

https://www.emergobyul.com/services/brazil/anvisa-registration-brazil

Brazil's ANVISA medical device regulations. Brazil is the largest medical device market in Latin America, with an established but complex regulatory system. Medical devices …

Brazil’s New Rules for Class II Medical Devices | RegDesk

https://www.regdesk.co/brazil-anvisa-class-ii-medical-devices/

Brazil’s New Rules for Class II Medical Devices. Sep 23, 2020. The National Health Surveillance Agency (ANVISA) of Brazil has announced changes in the regulations on Class II medical devices. The …

Brazil - Import Requirements and Documentation

https://legacy.export.gov/article?id=Brazil-Import-Requirements-and-Documentation

Such products can only be imported and sold in Brazil if the foreign company establishes a local Brazilian manufacturing unit or local office, or the foreign company appoints a …

How to Import Medical Equipment to Brazil - The Brazil …

https://thebrazilbusiness.com/article/how-to-import-medical-equipment-to-brazil

As previously stated, Brazil imports a large amount of medical equipment. Usually products that require more advanced technology come from abroad, but some simpler items are …

How to Sell Medical Products in Brazil - Botinha & Cabral

https://www.lawyerinbrazil.com/regulatory-framework-for-importing-and-selling-medical-devices-2/

In order to import and sell most of the medical devices, pharmaceuticals, cosmetics, food, supplements, sanitary and veterinary products in Brazil, your company may need a …

Our Guide for How to Register Medical Devices in Brazil

https://www.regdesk.co/guide-register-medical-devices-brazil/

Jan 17, 2019. In Brazil, the institution that oversees medical device regulations is the Brazilian National Health Surveillance Agency (ANVISA). The beginning of the medical device registration process …