“It is crucial to rely on professional and trustworthy partners. We are happy to have found this partner in DOMO Salute”.

– Tobias Zobel, Director of the d.hip and Ambassador of the Medical Valley, EMN, Germany (Germany).

 

“We have been using DOMO Salute since July 2018, and I have to say that it has transformed the way we do registrations in Brazil”

– Edwin Martinez, Director of QA/RA MedXChange (USA).

 

health regulatory consulting

Our team of regulatory affairs professionals has a wealth of regulatory experience that covers all the requirements related to medical device’s registration in Brazil. Together we know this industry inside out.

ABOUT US

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

 

We are proud of our experienced and adaptable team of consultants who have extensive experience in the fields of regulatory strategies, audits, applications and interaction with the Brazilian authorities, such as ANVISA, INMETRO and ANATEL.

 

We provide a client-driven, just-in-time consulting service, focused on delivering highly individualized regulatory solutions. DOMO Salute means House of Health and it reflects our desire to promote a positive atmosphere and build a trust-based partnership with all our clients.

 

Every project is treated uniquely. What this means is that you can expect a high quality, structured, professional approach to all phases of your project.

WHY DOMO?

EASILY ACESSIBLE

Our team of experts is friendly and easy to approach, you are free to ask any questions and DOMO will get back to you in a very short time.

CUSTOMIZED SOLUTIONS

One size does not fit all. DOMO takes time to understand your product and offers technical guidance that is built specifically for you.

NO SURPRISES

From the beginning you will know exactly the paths your medical device will take and the total cost of the project.

SAFETY

We handle your regulatory project very carefully.

TESTIMONIALS

It has been a great pleasure for me to work with the DOMO Salute team. We have already developed several projects together, all with great success, leading to obtaining the product registration before the expected deadline. Quick answers, differentiated service, highly trained professionals! We [...]
-Marli Vieira – Regional Business Director Latin America FRANKENMAN (China)
We have been using DOMO Salute since July 2018, and I have to say that is has transformed the way we do registrations in Brazil.   DOMO Salute provides Med X Change with critical insight of the Brazil regulatory landscape, allowing us to make fast and educated decisions when it comes to [...]
-Edwin Martinez – Director of QA/RA MedXChange (USA)
As an international network of companies and healthcare providers it is crucial to rely on professional and trustworthy partners. We are happy to have found this partner in DOMO salute with whom we have already registered various medical devices without any objections. We were also surprised [...]
-Tobias Zobel – Director of the Digital Health Innovation Platform (d.hip) and ambassador of the Medical Valley EMN, Germany². (Germany)
On behalf of Max Cirúrgica, I would like to thank you very much for all services provided by DOMO Salute and its respective employees in the hiring and preparation of INMETRO certification and ANVISA product registration project. We were extremely pleased with all the service, agility, [...]
-Emerson Almeida – National Manager of Sales and Products MaxCirúrgica (Brazil)
Domo Salute´s team is highly professional and we were more than convinced that we chose the right partner. Thanks for the excellent project.
-Maik Endler – Managing Director knoell Brazil

OUR KEY EXPERTS

Our experts look forward to bringing unique capabilities and approaches to your company. Get to know the members of our team and find out what they bring to our company

Diego Louzada, Ing.

Business Development Manager

Diego Louzada, Ing.

16 years ago, he started working for an INMETRO/ANATEL/ANVISA accredited test laboratory. Since then, he has been developing a deep knowledge of the Brazilian regulatory system. Diego has worked for the past eight years assisting companies getting their INMETRO/ANATEL
certification. He has been working as a regulatory affairs consultant building strong relationships with regulatory agencies, accredited test laboratories and players from the Brazilian health market. Diego brings a fresh view to every project, has great communication skills and works opening new markets and building trust-based long lasting relationships.

Thatiana Terroso, Pharm, PhD.

Regulatory Manager.

Thatiana Terroso, Pharm, PhD.

Thatiana has a Pharmaceutical-Industrial degree, obtained her masters and PhD degree in Pharmaceutical Science, having focused her academics studies in Nanotechnology and she also completed a MBA on Innovation Management. Before joining DOMO, Thatiana worked as a consultant for technological innovation projects, nanotechnology cosmetics laboratories and industries. She applies her deep product development knowledge assisting companies register their devices in Brazil. Over the past years she has acquired a profound comprehension of ANVISA’s regulatory guidelines. Thatiana is always able to understand your devices’ unique needs and determine the best approach for your regulatory strategy.

Amanda Frasson, Pharm, PhD.

Regulatory Manager.

Amanda Frasson, Pharm, PhD.

Amanda obtained her PhD degree in Pharmaceutical Science from a Brazil-Canada cooperation. Having managed a variety of regulatory and quality assurance projects, Amanda has grown to become an expert able to support global companies. With her background she is able to assist clients with the Brazilian regulatory requirements, having completed many regulatory applications for GMP certification and product registration. Amanda is always focused on providing a high quality structured service to all clients.

Maurício Avila, Ing.

Business Developer.

Maurício Avila, Ing.

Mauricio is graduated in Production Engineering and earned his MBA in International Business. He has more than 14 years work experience in conformity assessment issues, and has performed technical and sales roles for national and international companies. Through his career he has engaged in product certification and the standardization area, building up a deep understanding of the regulatory paths foreign companies can face entering our market. He is also an expert in business development and project management and his work experience means he can offer a broad understanding of the global medical device’s regulatory sector. Working as DOMO’s US business developer, Maurício ensures our clients are much closer to the Brazilian market.

Luciano Duarte, Ing, MSc.

Senior Manager.

Luciano Duarte, Ing, MSc.

A mechanical engineer by profession, Luciano has studied medical device’s development at a masters level by a Brazil – Czech Republic cooperation. He has participated extensively in medical/surgical R&D projects over the past 20 years. Performing the technical responsible role before ANVISA for over 15 years, he has also acquired regulatory expertise. Luciano is an entrepreneur, investor and mentor to health startups.

Maike Reuwsaat, Pharm.

GMP Quality Management System Specialist.

Maike Reuwsaat, Pharm.

Industrial Pharmacist post graduated in Quality System Management (QSM), she has more than 10 years experience in human and veterinary medicine industries developing new production lines and developing/registering products. For over 20 years she has been working as a regulatory affairs consultant for medical devices, medicines, cosmetics, cleaning products and food companies, having built a solid relationship with regulatory authorities such as ANVISA and the Agricultural Health Ministry. Through her career, her main focus was on Good Manufacturing Practices implementation and audits. Maike has worked with hundreds of companies globally and she brings extensive experience on GMP and in loco audits.

LATEST NEWS

ANVISA publishes RDC n °183-2017 that changes procedures for concession of Certificate of Good Manufacturing
11/15/2017
On October 19th 2017, ANVISA published the RDC nº 183 which complements the provisions of RDC nº 39/2013. The new legislation amends the list of documents required for GMP application protocol, making it mandatory to submit further information on the latest inspections and audits carried out at the manufacturing plant subject to certification. [...]
See more >
ANVISA Extends the Validity of Medical Device Registry to Ten Years
01/31/2018
On January 23 2018, ANVISA issued Resolution RDC 211 and RDC 212/2018, which deal with the validity period of medical device registry, as well as with the procedures related to the renewal of product registration. According to the new legislation, the registries of medical devices and IVDs (risk classes III and IV) will have a...
See more >
Medica Fair
10/30/2018
Domo Salute will attend Medica Fair 2018 in Düsseldorf – Alemanha from November 12th to 15th, 2018. Medica is the leading international trade fair for medical sector and it is a very attractive event: more than 5100 exhibitors from 66 nations. It will be a pleasure to meet you there if you will attend the...
See more >
Arab Health 2019 in Dubai and DOMO Salute will be there
01/04/2019
Link para o vídeo: https://youtu.be/PicwqlhAELI Arab Health is the largest healthcare event in the MENA (Middle East and North Africa) region. More than 4,150 exhibitors from 160 countries and 84,500 visitors expected to attend Arab Health 2019 taking place from 28 – 31 January in Dubai, UAE and DOMO SALUTE will be part of it...
See more >
PUBLIC CONSULTATION ANVISA- single use and reusable medical devices
01/15/2019
Some medical devices may be used more than once and be reprocessed safely. This practice gives them a longer product life and use, as long as they provide effectiveness and functionality. Medical devices that may be processed are those that allow repeated cleaning, disinfection or sterilization and that can be reused, given they comply with... [...]
See more >
Medical devices now enjoy the use of electronic petition
01/23/2019
ANVISA opened on Monday (January 21thst), in the Electronic Petitioning System, the Electronic Compliance of Requirements for Medical Devices. According to the Agency, of February 25, the subject codes of secondary petitions (changes, revalidations, additions, cancellations, rectifications, among others) will also be available for electronic [...]
See more >
Welcome Saúde 2019- the event that presented the political and economic perspectives for the health
01/31/2019
On January 29th, Domo Salute attended the event “Welcome Saúde 2019 ”(link event) organized by Media Group to welcome the health sector this year. The event discussed the political and economic perspectives for the sector and brought experts and authorities from different links in the health chain. A survey conducted by Media Group noted [...]
See more >
Brazil has a new Minister of Health: Luiz Henrique Mandetta
02/06/2019
  Jair Bolsonaro, Brazil’s new president, began his four-year mandate on January 1st. One of the attributions of the new Brazilian leader is the structuring of his team and his ministers are the most important people in this group. The new Health Minister, Luiz Henrique Mandeta, is a doctor from Campo Grande city, Mato Grosso...
See more >
Class I Medical Devices Notification
03/12/2019
On March 1st, 2019, ANVISA published RDC 270 / 2019 in the Brazilian Official Gazette. The new legislation deals with the migration of the cadastro route to the notification route for Class I medical devices (materials, equipment and IVD products). RDC 270/2019 amends RDCs 36 and 40/2015 and shall enter into force as of May...
See more >
How were SAHE (South America Health Exhibition) and Expert Directory Event 2019
03/25/2019
DOMO Salute attended two events this month: SAHE (South America Health Exhibition) and Expert Directory Event 2019, promoted by Swiss Business Hub Brasil. SAHE, which took place from March 12th to March 14th, held more than twenty forums, gathering over 400 speakers throughout the three-day schedule, thus offering around 400 hours of content [...]
See more >
What about INMETRO
03/28/2019
A significant number of manufacturers that look for our regulatory services are not just searching for ANVISA registration services, their doubts are related to INMETRO certification processes and their requirements, which many times are not thoroughly discussed when planning a regulatory strategy for medical devices’ registration in Brazil. [...]
See more >
Domo Salute at the 26th edition of Hospitalar Trade Fair
06/05/2019
For the third consecutive year, Domo Salute has participated in the most relevant Latin American showcase in the health sector: Hospitalar Trade Fair. At Rio Grande do Sul’s collective stand, which was organized by Sebrae RS, Health Technology Cluster and the State Government, companies had the opportunity to advertise their products and [...]
See more >
BRAZIL’s INMETRO proposing new model
07/19/2019
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. The action is a part of...
See more >
ANVISA`s Regulatory guillotine
07/30/2019
In 2014, ANVISA created a management model for its regulatory stock based on the organization of thecurrent rules, monitoring their effectiveness and generating inputs for their review. The goal was, and still is, to make the stock more efficient, rational, clear and understandable.   According to civil servant Raianne Liberal [...]
See more >
ANVISA’s performance report: An analysis on medical device and IVD registration
08/23/2019
ANVISA has published the second trimestral GGTPS (Medical Device Technology General Management) performance report. The report presents data, results and metrics concerning the first two trimesters of 2019. The first report, published ion April, can be found on ANVISA’s website. According to Leandro Rodrigues Pereira, General Manager of the [...]
See more >
ANVISA’s special report: 2018 results
09/05/2019
ANVISA publishes 2018 management results Brazilian medical device market regulator ANVISA recently published the annual Management Report concerning 2018’s results. According to Willian Dib, ANVISA’s CEO, presenting the annual report to the society reaffirms the Agency’s commitment and transparency. DOMO’s Team has evaluated the report and [...]
See more >
Contacting Brazilian Regulatory Agencies – ANVISA, INMETRO e ANATEL
09/20/2019
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.   ANVISA   Central de Atendimento / Call [...]
See more >
ANVISA’s Digital Plan
10/17/2019
  ANVISA, the Ministry of Economy and the Presidency approved, on Wednesday (9/10), the Agency’s Digital Plan. As a part of the strategy to implement the Executive Power’s Digital Governance Policy, the program wishes to transform 120 ANVISA services to digital by the end of 2020. Throughout 2019 we have had significant [...]
See more >
Brazilian Regulatory System – News Roundup
10/25/2019
Our team has compiled a few important news from the past days concerning medical device’s regulation and the Brazilian regulatory system:   Field safety correction action information is now submitted to ANVISA by electronic system    Since the 22th of July manufacturers must submit field safety correction action information via [...]
See more >
Meet our team at MEDICA 2019
10/29/2019
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, Germany. We’ll be at MEDICA 2019 to talk about how we’re helping medical device companies bring to market new products to Brazil, and discuss the key areas of...
See more >
BRAZIL’s INMETRO proposing new model
11/10/2019
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. The action is a part of...
See more >
Brazilian Regulatory System – News Roundup
11/10/2019
Our team has compiled a few important news from the past days concerning medical device’s regulation and the Brazilian regulatory system:   ANATEL – New regulation for Conformity Assessment and Homologation of Telecommunication Products   ANATEL approved on October 17th, the new Regulations for Conformity Assessment and Homologation [...]
See more >