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
Collaboration with DOMO Salute has been a very pleasant experience. The process was smooth, friendly, professional and incredibly swift. This was our first registration in Brazilian markets and I’m very excited to get to know the Brazilian medical device field. New market is not scary at [...]
– Laura Mattinen – Etsimo Healthcare (Finland)
We have been using DOMO Salute to register our AI application in neurology for clinical use in Brazil. We are very pleased with all aspects of DOMO salute’s work. They provided clear instructions around what material was needed and communication with staff was very friendly and competent, with [...]
– Lennart Thurfjell – CEO Combinostics (Finland)
I have been collaborating with DOMO Salute for registering our AI software-based products as medical devices in ANVISA. It has been a great pleasure to work with this professional team that has provided the best advice to make the best decisions in order to receive ANVISA registration [...]
– Alvaro Perez Moreno, PhD – CTO Transmural Biotech S. L. (Spain)

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 423/2020 extinguishing the CADASTRO route
09/18/2020
ANVISA published today (September 18th) the Resolution 423/2020 which establishes that Risk Class II medical devices that were previously under the CADASTRO regime, will be now taking the NOTIFICATION route. Last year (March 1st) ANVISA had established the NOTIFICATION route for Risk Class I devices through RDC 270/2019. Under the new [...]
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Covid-19 Post market surveillance
09/14/2020
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. One of the platforms is the Post-Market Monitoring of the quality of Covid-19 related [...]
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RDC Nº 346/2020 validity extended
09/04/2020
ANVISA published yesterday (September 3rd) RDC 419/2020 extending the validity of the RDC 346/2020 which defines extraordinary and temporary criteria and procedures for GMP Certification, for  registration purposes and post-registration changes to active pharmaceutical ingredients, medicines and medical devices, due to the international public [...]
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ANVISA: Alterations on your regularized medical device
07/23/2020
From April this year, ANVISA implemented new rules for the classification of petitions for the alteration of medical devices. According to ANVISA, the measures, ruled by RDC 340/2020 and IN 61/2020, aim to define different categories for alterations on medical devices based on their risk, making clear which changes have to be previously [...]
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ANVISA’s special report: 2019 results
07/10/2020
ANVISA has made available on their website the annual Management Report, concerning 2019’s results and the governance of the Agency. The report aims to make available to the society general data and specific information from technical departments. The report shows that the Agency has achieved good results and an increasing number of medical [...]
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Are Remote Audits an option when accessing the Brazilian medical device market?
05/22/2020
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 INMETRO are dealing with this? Remote [...]
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Brazilian Regulatory Agencies & Covid-19
04/28/2020
In response to the COVID-19 outbreak, Brazilian regulatory agencies (ANVISA & INMETRO), as well as many other regulators around the world, have released in the past month Ordinances and Resolutions regarding emergency and temporary procedures for medical devices that are strategic to fight against the pandemic. The regulations include new [...]
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INMETRO’s temporary procedures facing the new Coronavirus
04/07/2020
Updated on July 2nd 2020: INMETRO published, on the 30th of June, Ordinance nº 225 which extended the terms and temporary procedures for Conformity Assessments, due to the international public health emergency resulting from the new Coronavirus. The Ordinance extends the possibility of remote audits until December 31st 2020, as well as [...]
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New temporary procedures for the manufacture, import and acquisition of strategic medical devices announced to fight the new Coronavirus
03/24/2020
ANVISA published RDC 356/2020 regarding extraordinary and temporary procedures on the requirements for the manufacture, import and acquisition of medical devices identified as priorities by ANVISA due to the international public health emergency resulting from the new Coronavirus. Our team prepared a few highlights with important changes: * [...]
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Temporary procedures for personal protective equipments, pulmonary ventilators and strategic medical devices regularization in Brazil announced to fight the new Coronavirus 
03/21/2020
ANVISA published yesterday RDC 349/2020 regarding temporary procedures for requests for the regularization of personal protective equipments, pulmonary ventilator medical equipments and other medical devices identified as strategic by ANVISA due to the international public health emergency resulting from the new Coronavirus. Our team prepared [...]
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ANVISA’S measures on medical devices during the Covid-19 Pandemic
03/17/2020
Covid-19: Prioritizing IVD products Last Thursday (03/12/2020) ANVISA published an update regarding IVD products for Covid-19 diagnosis aiming to speed products regularization and the offer of diagnostics. ANVISA will prioritize the analysis of all processes related to products for Covid-19 diagnosis and other agents that cause respiratory [...]
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Foreign participation in Brazilian public tenders becomes more simple
02/28/2020
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. According to the Normative Instruction, foreign companies must open a National Corporate Taxpayer Registry [...]
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Using the MDSAP Program to enter the Brazilian Market
02/20/2020
The Medical Device Single Audit Program (MDSAP) is a program developed by IMDRF (International Medical Device Regulators Forum) that allows the conduct of a single regulatory audit of a medical device manufacturer’s quality management system that satisfies the requirements of multiple regulatory jurisdictions. Audits are conducted by Auditing [...]
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ANVISA’s upcoming regulation on SaMD’s – Software as Medical Device –
02/14/2020
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 [...]
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ANVISA publishes IMDRF Guides for medical devices’ Clinical Evaluation
01/16/2020
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 appropriate to meet technical or [...]
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Normative Instruction 49/2019 updates list of Technical Standards for medical device compliance certification
01/03/2020
  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 came into effect immediately after the publication (22nd November 2019). It is important to highlight that Normative Instructions No. 4  (September [...]
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ANVISA’s Public Consultation nº 730/2019 and 734/2019
12/06/2019
  Updates regarding Definitions, Classification, Registration Pathways, Labeling and Instructions for Use requirements for Medical Devices and IVD Medical Devices   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 [...]
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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...
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Brazilian Regulatory System – News Roundup
10/24/2019
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 of [...]
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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 progress [...]
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ANVISA publishes new rules for custom-made devices
09/30/2019
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 [...]
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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 Center The phone [...]
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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 [...]
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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 [...]
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Brazilian Regulatory System – News Roundup
08/16/2019
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 ANVISA’s electronic [...]
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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 Coutinho, the [...]
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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...
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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 [...]
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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. [...]
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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 [...]
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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...
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Arab Health 2019 in Dubai and DOMO Salute will be there
02/14/2019
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 for the first time. It...
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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...
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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”, 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 that 55% of... [...]
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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 [...]
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PUBLIC CONSULTATION ANVISA – single use and reusable medical devices
01/16/2019
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... [...]
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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...
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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...
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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 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. [...]
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