Domo Salute

16/11/2020

Spread the word! We prepared a short video to help you understand who we are and what we do. If you're planning on entering the Brazilian medical device's market, contact us at [email protected].

We are a medical device regulatory consulting firm assisting foreign companies through the Brazilian regulatory system, enabling their access to our growing ...

14/09/2020

In tackling the Covid-19 pandemic ANVISA has been focusing on the transparency of data, and recently made available for consultation, through Business Intelligence (BI) platforms, the results from monitoring Covid-19 related products and diagnostic tests. Learn more >>>>

In tackling the Covid-19 pandemic ANVISA has been focusing on the transparency of data, and recently made available for consultation, through Business Intelligence (BI) platforms, the results from monitoring Covid-19 related products and diagnostic tests.

11/08/2020

Nós acreditamos que o empreendedorismo é a grande chave de mudanças em todo o planeta, e isto independe da área de atuação. O empreendedorismo na saúde tem sido uma ótima saída para melhorar a realidade em que vivemos. É preciso, no entanto, antes de iniciar um negócio na área, obter informações a respeito das particularidades e responsabilidades inerentes ao mercado.

Nossa equipe desenvolveu um Guia no intuito de auxiliar empresas nacionais a compreender quais são os requisitos básicos para ingressar no crescente mercado de produtos para saúde.

Temos o compromisso de contribuir para o crescimento do mercado nacional e para o acesso da população à produtos cuja segurança é atestada pelas Agências Regulatórias nacionais.

Faça o download gratuito e saiba mais sobre como ingressar no mercado de dispositivos médicos no Brasil >> https://lnkd.in/dngxqAC

25/05/2020

How do you conduct a third-party audit, required for market access, when most of us must work remotely? How the Brazilian Regulatory Agencies such as ANVISA and INMETRO are dealing with this? Check on or blog the article written by our business developer Mauricio Wahast Avila, lead auditor for ISO13485 and MDSAP. --------

Medical device manufacturers are providing life-saving equipment to care for patients who have been infected with the new coronavirus. But how do you conduct a third-party audit, required for market access, when most of us must work remotely? How the Brazilian Regulatory Agencies such as ANVISA and....

07/04/2020

INMETRO recently published Ordinance nº 111, regarding extraordinary and temporary procedures for Conformity Assessments, due to the international public health emergency resulting from the new Coronavirus. Our team prepared a few highlights on the most important topics. Check today's blog post >>>>>>>

INMETRO published, on the 27th of March, Ordinance nº 111, regarding extraordinary and temporary procedures for Conformity Assessments, due to the international public health emergency resulting from the new Coronavirus.

28/02/2020

Normative Instruction 10 from the Ministry of Economy reduced the barriers to the presence of external companies in federal bids. Nowadays, 46% of the Health System is supported by the Government through the Unified Health System. The recent changes represent huge business opportunities for foreign companies wishing to enter the Brazilian market. Learn more >>>>>>>

Published on Tuesday (11) in the Federal Official Gazette, Normative Instruction 10 from the Ministry of Economy reduced the barriers to the presence of external companies in federal bids. The new rules will take effect on May 11, 2020.

20/02/2020

A report from the end of 2019, released by ANVISA, shows a significant increase in medical device manufacturers participating in the MDSAP, reporting that 48,7% of all international GMP certificates issued by ANVISA in 2019 were through MDSAP audit. It is the largest number of participating companies since the beginning of the program, in 2015. Learn more about the Program on today's blog post >>>>>>>

A report from the end of 2019, released by ANVISA, shows a significant increase in medical device manufacturers participating in the MDSAP, reporting that 48,7% of all international GMP certificates issued by ANVISA in 2019 were through MDSAP audit. It is the largest number of participating companie...

14/02/2020

ANVISA published in January the SaMD Regulatory Impact Analysis Report regarding important information for the safe and effective use of medical softwares as well as the sanitary actions associated with these products . According to the Agency, traditional regulations for medical devices have a gap, as they do not cover specific aspects for this type of product. Learn more about ANVISA's plans and the upcoming Regulation. >>>>>>

ANVISA aims to develop a new regulatory model exclusively for the virtual and disruptive context of medical software, to be in alignment with international regulatory bodies, to make developers aware of regularization and to bring cybersecurity regulation on connected devices.

16/01/2020

ANVISA published three Guides related to the medical devices' clinical evaluation scenario in Brazil. The Guides express ANVISA’s understanding of best practices regarding procedures, routines and methods deemed appropriate to meet technical and administrative requirements. Learn more >>>

ANVISA published last December three Guides from the International Medical Device Regulators Forum (IMDRF), related to the scenario of clinical evaluation of medical devices in Brazil. The Guides express ANVISA's understanding of best practices regarding procedures, routines and methods deemed appro...

03/01/2020

ANVISA published last November the Normative Instruction number 49, which has come into effect immediately after the publication. The new list of standards includes updates, additions, and deletions that must be considered for new medical device compliance certification processes (Notification, Cadastro, Registro, , alterations and revalidations). Check more on today's post >>>>>

In order to approve and update the list of Technical Standards equipment under Health Surveillance must comply with, ANVISA published last November the Normative Instruction number 49, which has come into effect immediately since the publication date.

23/12/2019

May your Christmas be filled with special moments, and your New Year with peace and happiness. With our deepest gratitude for 2019's partnership - Happy Holidays from DOMO's team!

13/12/2019

DOMO's experts prepared highlights concerning the proposed changes being discussed through Public Consultation 730 and 734/2019, in comparison to the current regulation (RDC 185/2001 and 36/2015). Check our post to learn more >>>

ANVISA has opened in last October the Public Consultation 730/2019 to discuss with the community updating RDC 185/2001, the standard that drives medical device registration in Brazil.