DUNNIA MEDICAL SOLUTIONS LLC.

Medical Equipment ManufacturingFlorida, United States11-50 Employees

ANVISA - REGULATORY AFFAIRS - HOSTING SERVICES

Established since 1993, our headquarters are located in the nation’s capital Brasilia-DF in proximity to the Brazilian Health Surveillance Agency - ANVISA (equivalent to the US FDA) and Ministry of Agriculture – MAPA (veterinary and agricultural products)  with a branch in the city of Orlando-FL (USA). 
We specialize in regulatory affairs with ANVISA and MAPA. Up to date with over 200 GMP’s and 15,000 products registered.  

Our knowledge, expertise and licenses cover the following fields and markets: 

Medical Devices – Cosmetics;
Sanitary products - Supplements;
Veterinary products; 

All of our technical staff is composed of former employees of ANVISA and MAPA, with extensive experience in legal and administrative procedures.

OUR SOLUTIONS 

Hosting services
Foreign companies that do not have a Brazilian branch must appoint a Brazilian Registration Holder – BRH. 
Dunnia Group acts as a link between your company and ANVISA / MAPA and is responsible for your registration in Brazil. Your company has total ownership and control of the registration. 

Brazilian GMP
B-GMP certification is required for manufactures of class III and IV medical devices and class II, III, IV IVD products. Dunnia already approved over 200 companies Worldwide.  Our service includes: Fast trails, mock inspections and follow up ANVISA’s Official Inspection. 

Product Registration
Product registration is a complex process that is a major expenditure of employee hours and capital for a company. Dunnia Group has a multidisciplinary comprehensive staff of professionals with over 22 years of expertise in product registration. Our staff has extensive experience in the industry routine focusing their efforts on shortening the process while adhering to ANVISA's and MAPA’s strict standards. The result is our clients obtain registrations faster at a lower cost. This is essential to the manufacture, import and marketing of products.

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