We have more than 21 years of expertise.

Dunnia Medical has over 5,000 AFE approved, 200 GMP and over 15,000 approved products in Brazil.

Foreign medical device and cosmetics manufacturers or distributors / exporters that do not have a Brazilian branch must appoint a Brazilian Registration Holder – BRH. This company acts as a link between your company and National Health Surveillance Agency – ANVISA and is responsible for your registration in Brazil. Dunnia Group, with offices in Brasilia – BRAZIL and Orlando, Florida – USA, can act as your BRH.

Companies that want to sell medical devices or IVD products in Brazil must comply with Brazilian Good Manufacturing Practice (GMP) quality system requirements. With ANVISA’s release of RDC 15/2014, B-GMP certification is only required for manufacturers of Class III and IV medical devices and Class II, III and IV IVDs.

The products registration at ANVISA is a complex process that expends company time and money, which sometimes allocates professionals from other departments to perform this kind of work. Dunnia Group has over 21 years strong expertise in product registration, with a multidisciplinary staff composed of professionals with comprehensive experience on industry routine, focusing their efforts in order to allow the shortening of the process as requested by the clients while adhering to the specified standards by ANVISA.

Keep In Touch!

Dunnia Medical has offices in Brazil and the United States, facilitating the process of dialogue with the authorities responsible for your success.

Please contact us through our social networks, contact forms, phones, emails. Anyway the Dunnia Medical is ready to serve you in the best possible way.

Recent News

29

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Animal testing is one step closer to being an illegal practice in Brazil. Last night the Brazilian Senate Commission of Science and Technology voted unanimously in favor of the cruelty-free law. The ...

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Feb
The Public Consultation (CP) n ° 313 of February 23, 2017, updating the administrative procedure for the toxicological re-evaluation of pesticides with indications of changes in the risks to human ...

Why Choose Dunnia Medical?

1. 21 years experience

We are a Consulting company with over 21 years experience.

2. Located in Brazil and the USA

Dunnia Group is located in Brazil and the USA as well; our contracts / Agreements follow the US Law.

3. Client Portfolio

Our client portfolio is composed of small businesses up to multinationals;

4. Experienced professionals

The work is performed by experienced professionals and with strong know-how on product registration;

5. Our staff registers and follows

Our staff registers and follows, in loco (Our Brazilian Office is located few minutes from ANVISA Headquarter);