RMG – REGISTRATION HOSTING
Imagine that a company located abroad wanted to register and commercialize its products in Brazil. There are 2 different ways to do that:
1. Establish a Brazilian company, which will necessarily have to obtain:
a. Registration at the Board of Trade;
b. Registration at the State Department of Finance;
c. Registration at the City Hall;
d. License at the Sanitary Vigilance (ANVISA);
e. Brazilian Operation License (AFE – Autorização de Funcionamento);
f. Brazilian qualified technician;
g. Registration at the Brazilian Ministry of Public Health;
h. Qualified workforce.
2. Hire a registration hosting service with a Brazilian company already duly authorized, dismissing all the requirements above.
When choosing the second option, the foreign manufacturer will be able to petition its product registration immediately, with almost no bureaucracy, for it will make use of all authorizations, permissions and licenses already acquired by the hoster (registration holder). Otherwise, in the absence of the hosting service, it may take up to 2 years do initiate the registration process.
It is a strategic alternative because, in addition to dismissing the regularization of a foreign company in the Brazilian soil, which will save time and money, it may serve as platform to test the national market. It may register under the hosting service medical devices, equipment, health products, pharmaceuticals, materials, food, sanitizing and hygiene products, cosmetics, in vitro diagnostic devices, housewares and others.
Due to the growing demand, by foreign companies, for a fast, practical and safe way to enter the Brazilian market, Register Medical Group – RMG – has been providing, for more than 20 years, the registration hosting service, with special focus on medical devices, equipment and health products.
In addition, RMG, situated less than 10 minutes from the national ANVISA’s headquarters, offers regulatory consultancy services during the entire register chain, which includes technical and legal assistance in obtaining the GMP – Good Manufacturing Practices Certificate, specially for products with risk category III and IV.
Yet, RMG owns a subsidiary called “Saúde Import”, and has numerous associates that are responsible for product distribution and merchandising in a national integrated network – a service available for clients that request it.
It is particularly important to note that hiring the hosting service does not bind the product distribution to the hoster (registration holder). This means that it is perfectly possible for RMG to host the registration and give as many authorizations for distribution – Registration Holder Declaration, as called in Brazil – as required by the foreign manufacturer.
Arábia Saudita, Argentina, Austrália, Brasil, Canadá, China, Colômbia, Costa Rica, Egito, Estados Unidos, Europa, Hong Kong, Índia, Israel, Malásia, México, Nova Zelândia, Rússia, Singapura, Taiwan
- Auditorias e Sistemas de Qualidade
- Consultoria e Assessoria Regulamentar
- Distribuidores de Produtos – Qualificação
- Representação Local
FALE COM UM CONSULTOR
REGISTRO DE PRODUTOS
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