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.

29/11/2019

We are pleased to announce the launch of our brand new website! We hope you find the website with a fresh look and easy to access information. We work on making it a valuable source of information and a way to connect with our team. A special thanks to our clients who kindly provided testimonials about their experience working with us!

Domo Salute is a health regulatory consulting firm with assistance for foreign companies through the Brazilian regulatory system.

21/11/2019

Today we ended another very successful participation at MEDICA Fair, including our Regulatory Affairs Manager - Diego Louzada - great presentation on the latest regulatory developments from Brazil. We would like to thank everyone who took some time to meet us and discuss Brazilian Regulatory Affairs, the event brought together an amazing group and we believe it was a great success!

We look forward to the next events.

31/10/2019

In October we have been celebrating DOMO's 3 year anniversary! We have already accomplished so much in such a short amount of time, it's truly been remarkable. Thank you to all who have been a part of our progress, to our team who work tirelessly to do great work, and to all the clients who have chosen to work with us!

29/10/2019

We’ll be at MEDICA 2019 to talk about how we’re helping medical devices companies bring to market new products to Brazil, and discuss the key areas of opportunity that exist today in the Brazilian Market.

We are proud to participate once again the world’s largest event for the medical sector - MEDICA 2019 - from November 18th to November 21st in Düsseldorf, Germa

25/10/2019

Our team has compiled a few important news from the past days concerning medical device’s regulation and the Brazilian regulatory system, including ANATEL's New regulation for Conformity Assessment and Homologation of Telecommunication Products. Check on our blog >>>

Our team has compiled a few important news from the past days concerning medical device’s regulation and the Brazilian regulatory system: ANATEL – New regulatio

17/10/2019

ANVISA's Digital Plan, that was recently approved, aims to transform 120 ANVISA services to digital by the end of 2020. Learn more about the Plan on today's blog post >>>

ANVISA, the Ministry of Economy and the Presidency approved, on Wednesday (9/10), the Agency's Digital Plan.

30/09/2019

The world's first standard fully aligned with the International Medical Device Regulators Forum's definitions is Brazilian! - Brazilian medical device market regulator ANVISA published on September 24th new rules for manufacturing, importing, marketing and vigilance responsibilities concerning custom-made devices.

Under ANVISA’s current system, custom-made devices’ applications had to go through a specialized submission process, with no specific Brazilian regulations to serve as reference. RDC nº 305/2019 will come into effect from October 24th, 30 days after the official publication.

Learn more about RDC nº 305/2019 on our blog >>>>

Brazilian medical device market regulator ANVISA published on September 24th new rules for manufacturing, importing, marketing and vigilance responsibilities co

20/09/2019

ANVISA recently opened a new communication channel and our team prepared an update on all the available resources for contacting Brazilian key Regulatory Agencies, concerning medical devices. Knowing how to reach out to the agencies can help if you intend on entering the Brazilian Market. More on the blog >>>>>>

ANVISA recently opened a new communication channel and our team prepared an update on all the available resources for contacting Brazilian key Regulatory Agenci

05/09/2019

On the blog, we examined ANVISA's report: 2018's Management results. Check our team's analysis, highlights and the most important results from the report >>>

Brazilian medical device market regulator ANVISA recently published the annual Management Report concerning 2018’s results.

23/08/2019

Quick update: Starting next Monday (26/8), ANVISA will open a new communication channel - webchats. Through the service, citizens and companies will be able to communicate online, in real time, with ANVISA's Call Center attendants. Check their website for more information.

Devido à mudança, alguns serviços de atendimento ficarão indisponíveis nos próximos dias. Confira.

23/08/2019

ANVISA has published the second trimestral GGTPS (Medical Device Technology General Management) performance report. Check on our blog DOMO Salute’s team analysis on the report.

ANVISA has published the second trimestral GGTPS (Medical Device Technology General Management) performance report. The report presents data, results and metric

16/08/2019

Our team has compiled a few important news from the past days concerning medical device’s regulation and the Brazilian regulatory system. Check on our blog >>>

Our team has compiled a few important news from the past days concerning medical device’s regulation and the Brazilian regulatory system.

30/07/2019

In 2014, ANVISA created a management model for its regulatory stock based on the organization of the current rules, monitoring their effectiveness and generating inputs for their review. Learn more about ANVISA's Regulatory Guillotine and its outcomes on our blog.

In 2014, ANVISA created a management model for its regulatory stock based on the organization of the current rules, monitoring their effectiveness and generatin

24/07/2019

19/07/2019

INMETRO has issued a public consultation regarding the proposal for what they are calling a “New regulatory model for INMETRO”. The main goal, according to INMETRO’s director Gustavo Kuster, is to make Brazilian market safer for society and citizens and to create a less bureaucratic and more simple system. Read more on the blog:
https://www.domosalute.com.br/blog-1/brazil-inmetro-proposing-new-model

20/06/2019

17/06/2019

The INMETRO ordinance 259/2019, which proposes adjustments to the Conformity Assessment Requirements for Equipment under Health Surveillance Regime, approved by INMETRO ordinance 54 as of February 1st, 2016, is in public consultation and is going to be until July 28th, 2019. Among other goals, the adjustments aim to clarify some concepts of regulation 54 and the applicability of standards, as well as determine the obligation of certification bodies to inform ANVISA and INMETRO once they modify any certified equipment.
Share your comments with INMETRO, time to join in!
http://www.inmetro.gov.br/legislacao/rtac/pdf/RTAC002568.pdf

Está em consulta pública até dia 28 de julho de 2019 a portaria INMETRO 259/2019, que propõe ajustes nos Requisitos de Avaliação da Conformidade para Equipamentos sob Regime de Vigilância Sanitária, aprovado pela Portaria Inmetro nº 54, de 01 de fevereiro de 2016. Dentre outros fatores, os ajustes visam esclarecer conceitos da portaria 54, a aplicabilidade de normas assim como determinar a obrigatoriedade dos organismos certificadores de informar ANVISA e INMETRO quando da modificação em algum equipamento certificado.
Acesse na íntegra
http://www.inmetro.gov.br/legislacao/rtac/pdf/RTAC002568.pdf

13/06/2019

Venha trabalhar na DOMO Salute!
Vaga aberta para Analista Administrativo

Cursando ou formado em Administração;

Imprescindível: Experiência mínima de 2 anos.

Salário: R$ 2500

Atividades:
- Propor e manter indicadores de resultado ao negócio, desenvolvendo estudos, análises, diagnósticos, relacionados a área de custos e administrativo-financeira, gerando informações à tomada de decisão da gestão.
- Realizar atividades da área financeira: Controlar e realizar pagamentos; emitir NF-e, invoices internacionais, boletos bancários, recibos de pagamento, etc; realizar a operação cambial de recebimentos internacionais; controlar e tratar inadimplências; receber, organizar e manter a movimentação financeira; preparar o fluxo de caixa mensal com previsões futuras e gerar relatórios; controlar o Siscoserv; realizar contato direto com a contabilidade.
- Agendar reuniões, acompanhar e elaborar pautas, atas e planos de ação.
- Apoiar as atividades previstas no Planejamento estratégico.

Obrigatório:
- Inglês avançado
- Conhecimento de sistema de gestão/financeiro
- Pacote office e principalmente Excel

Desejável:
- Conhecimento em Marketing
- Experiência em coordenação de projetos, rotinas administrativas e organização de eventos

Carga horária: Regime CLT

Benefícios: VT e VR

Interessados enviar CV para [email protected]