By Julio G. Martinez-Clark, bioccess.™CEO; article originally published by Med Device Online.
Comprising 3.28 million square miles and 209 million citizens, Brazil is the world’s fifth-largest country in both area and population. Brazil also boasts one of the largest gross domestic product (GDP) outputs on Earth, fueled in part by Latin America’s largest medical device market (and one of the largest device markets in the world) in terms of revenue, manufacturing output, and imports.
Rising GDP, an expanding middle class, increasing life expectancy, and increasing disposable income is driving greater demand for medical devices throughout Latin America, especially in Brazil. This greater demand makes Brazil one of the best opportunities for medical device manufacturers in the world, meaning medtechs should expect an evolving regulatory system and a competitive environment.
This article — the first in a two-part series — examines the current state of Brazil’s medical device regulation, clarifying the general registration and certification process that manufacturers, importers, and distributors need to follow to commercialize their devices freely. Part two analyzes Brazil’s medical device market, including patient demographics and challenges OEMS must overcome to succeed.
Modernizing Market Access
In 1991, Brazil joined MERCOSUR, a South American economic and political trade bloc composed mainly of Brazil, Paraguay, Uruguay, Argentina, and Venezuela. Mercosur's goal is to facilitate free trade and the movement of goods, assets, and people in these countries. There are no customs duties between these countries; they have standard import tariffs for certain goods and homogeneous trade policies with other countries outside the bloc. 15
The National Health Surveillance Agency, also known as Anvisa, is a self-funded agency under the Brazilian Ministry of Health that has had the authority to regulate registration and commercialization of medical devices since 1993. Unlike the regulatory bodies of the European Union (EU), United States (US), or Canada, Anvisa carries out all registration and inspection processes within the agency, so only companies based in Brazil can apply for registration. Companies based elsewhere that do not have subsidiaries in Brazil must rely on third parties based in Brazil, such as host companies, distributors, and dealers.
Resolution RDC. No. 185, of October 22nd 2001 is the central regulation applicable to the registration of medical devices in Brazil, describing the protocol and documents required. Annex II of D.R.C. No. 185 describes the classification scheme, assigning medical devices to one of four risk classes (I, II, III, and IV), based upon various rules. This structure corresponds to that used in the EU. 1, 16 If a device fits more than one classification, its final class is the one associated with the highest risk level. 16, 15
Registration requirement complexity depends on this risk classification. Class I and II devices have a simplified process called "Cadastro," meaning "short registration." Products in the high-risk classes (III and IV) are subject to a more rigorous registration process called "Registro" that demands a specific set of requirements. 1, 16
Requirements for Class I and Class II (Cadastro):
If your company doesn’t have a presence in Brazil, you will need a licensed third-party company to be your Brazilian registration holder (BRH). This company will oversee the registration of your device and will hold the title of your registration certificate.
A letter from your company authorizing its BRH to apply at Anvisa.
A Certificate of Good Manufacturing Practices (GMP) obtained by successfully undergoing an Anvisa inspection. This certificate is challenging to transfer after registration.
Certification by The National Institute of Metrology, Standardization, and Industrial Quality (INMETRO) for electromedical devices. This certification is valid for five years and requires annual audits and payment of fees.
A technical file and a Cadastro application.
Payment of the application fee. For class I devices, your BRH will send an abbreviated application. For Class II devices, your BRH will need to send a complete application with all documents.
If Anvisa approves the application, you will receive a number in the Diário Oficial da Uniāo (DOU). This registration does not expire.
You can start marketing and selling your medical device as soon as you have an approved distributor to import your product into Brazil. 15
Requirements for Class III and Class IV (Registro); this pathway is similar to Cadastro, with some variations:
If your company doesn’t have a presence in Brazil, you will need a licensed third-party company to be your Brazilian registration holder (BRH). This company will oversee the registration of your device and will hold the title of your registration certificate.
A letter from your company authorizing its BRH to apply at Anvisa.
Provide a Brazil Good Manufacturing Practices (BGMP) certificate to Anvisa. Manufacturers must be audited by Anvisa for BGMP compliance. Fees are paid for these audits every two years, and Anvisa determines whether the inspection is on-site or off-site.
Certification by The National Institute of Metrology, Standardization, and Industrial Quality (INMETRO) for electromedical devices. This certification is valid for five years and requires annual audits and payment of fees.
A technical file, including clinical studies and information on the device, in compliance with RDC 185/2001.
All files relevant to the application fee payment and the application submission to Anvisa must be in Brazilian Portuguese.
If Anvisa approves the application, you will receive a number in the Diário Oficial da Uniāo (DOU). This registration will be valid for 10 years and will have to be renewed one year before it expires.
You can start marketing and selling your medical device as soon as you have an approved distributor to import your product into Brazil. 15
In May 2019, Anvisa issued RDC 270/2019, a new, streamlined class I device regularization system called "Notification" that provides simplified market access for low-risk devices, allowing regulators to focus more on licensing high-risk devices.
Now, Class I devices needn’t undergo full Cadastro approval. Requests for registration of class I devices are not subject to technical review, but consist of a formal notification to Anvisa. Applicants must wait for their notification number within 30 days of receipt of applications. Anvisa publishes Class I notifications only on its website. Manufacturers can begin marketing their devices in Brazil when they have received the notification numbers and added them to their product labeling.
Class I device notifications do not expire, but Anvisa can terminate notifications at any time for lack of proper documentation, incorrect classification, or complaints. The requirements of a limited stock-exhaustion period of 180 days no longer apply to class I devices. Manufacturers of Class I and II medical devices can market their products until prior versions of these devices expire. 16, 17
The new device regulation helps Anvisa better focus on high-risk medical devices, especially considering that class I applications account for more than 30 percent of its evaluation requests. RDC 270/2019 also aligns with similar rules established by regulators who are members of the International Forum of Medical Device Regulators (IMDRF) and allows manufacturers to market their devices faster in Brazil.
Since low-risk device approvals will not go through Anvisa review, manufacturers must have qualified regulatory teams who can accurately evaluate their classifications and certifications to guarantee they are eligible for notification, as well as avoid future compliance problems with Anvisa. 17
Note that implementation of this notification pathway does not change the required documentation (technical files, Anvisa application forms) for class I medical devices that already in the Cadastro registration process. 16, 31
Although the Brazilian regulatory system is perceived to be quite complicated, medical device regulators in Brazil are working to facilitate and modernize market access. Anvisa has issued two new inquiries proposing changes to long-standing regulations on medical devices and issued Public Consultation 730/2019 to update RDC 185/2001. Its improvements include classification, registration pathways, labeling requirements, and instructions for use (IFU).
The idea is for Brazil to be more closely aligned with the classification rules stipulated in the European Union’s Medical Devices Regulation (MDR). Brazilian regulators have also introduced new regulatory processes that focus on tailor-made, patient-specific medical devices, instead of the previous system, where manufacturers had to submit special applications to Anvisa to import such products into the country.16, 18, 19, 20
Conclusion
Brazil is a country increasingly aware of its healthcare practices and is on the way to implementing a compelling agenda in governance, recruitment of employees, suppliers, training of health professionals, risk mapping, transparency, and the rational use of resources.
However, significant government involvement and the effort to modernize has left the Brazilian healthcare market complex, asymmetric, fragmented, and in great demand. Understanding this is the baseline for discerning the opportunities and challenges of participating in a healthcare market among the most promising and attractive in the world.
You can find part two in this series here. It discusses challenges OEMs can expect to encounter in Brazil, as well as the nation’s patient demographics and exciting opportunities for the future.
About the author
Julio G. Martinez-Clark is C.E.O. of bioaccess, a U.S.-based contract research, regulatory, and market access consulting company focused on Latin America. Julio is also the host of the L.A.T.A.M. Medtech Leaders podcast and holds a bachelor's degree in electrical engineering (B.S.E.E.), and a master's degree in business administration (M.B.A.).
References
[Editor’s note: References are included below for both articles in the series]
Medical Device Approvals in Brazil: A Review and Update. Retrieved from https://legacy-uploads.ul.com/wp-content/uploads/sites/40/2015/02/UL_WP_Final_Medical-Device-Approvals-in-Brazil_v7_HR.pdf
The Healthcare market in Brazil. Retrieved from https://www.pwc.com.br/pt/publicacoes/setores-atividade/assets/saude/healthcare-tsp-13.pdf
Opportunities and challenges in the Brazilian Healthcare System. Retrieved from https://saudebusiness.com/mercado/opportunities-and-challenges-in-the-brazilian-healthcare-system/
Latin America medical device and equipment market. Retrieved from https://globalhealthintelligence.com/wp-content/uploads/2017/04/ghi-hc-market-size-brazil-20170313.pdf
Setor de equipamentos e dispositivos médicos volta a crescer em 2017. Retrieved from https://monitordigital.com.br/setor-de-equipamentos-e-dispositivos-m-dicos-volta-a-crescer-em-2017
State of the 2017 Medical Device Market in Brazil. Retrieved from https://globalhealthintelligence.com/ghi-analysis/state-of-the-2017-medical-device-market-in-brazil/
How to understand healthcare system and its technology in Brazil. Retrieved from http://brazcanchamber.org/wp-content/uploads/2019/06/How-to-understand-Healthcare-System-and-Its-Technology-in-Brazil.pdf
2018 Brazilian Health Market Outlook. Retrieved from https://globalhealthintelligence.com/ghi-analysis/2018-brazilian-health-market-outlook/
Brazil Medical Devices Market; Lucrative Investment Area for Players in Industry with Growth at CAGR of 9% during 2018 – 2023. Retrieved from https://www.medgadget.com/2018/05/brazil-medical-devices-market-lucrative-investment-area-for-players-in-industry-with-growth-at-cagr-of-9-during-2018-2023.html
Brazil suffers health care crisis as SUS system flounders. Retrieved from https://www.dw.com/en/brazil-suffers-health-care-crisis-as-sus-system-flounders/a-45480379
Flawed but fair: Brazil's health system reaches out to the poor. Retrieved from https://www.who.int/bulletin/volumes/86/4/08-030408/en/
Quality of the public health system: a systemic comprehension in Brazilian southern region. Retrieved from http://www.scielo.br/scielo.php?script=sci_arttext&pid=S0104-530X2019000100207&lng=en&nrm=iso&tlng=en
Brazil's healthcare system unprepared for fast-aging population. Retrieved from https://brazilian.report/business/2019/03/17/brazil-healthcare-system-pension-system/
User Experience of Brazilian Public Healthcare System. A case study on the accessibility of the information provided. Retrieved from https://www.tandfonline.com/doi/pdf/10.1080/14606925.2019.1595449
Our Guide for How to Register Medical Devices in Brazil. Retrieved from https://www.regdesk.co/guide-register-medical-devices-brazil/
Is your medical device ready for the Brazilian market? Retrieved from https://www.knoell.nl/en/news/your-medical-device-ready-brazilian-market
Brazil's ANVISA launching Notification pathway for low-risk medical devices and I.V.D.s. Retrieved from https://www.emergobyul.com/blog/2019/03/brazils-anvisa-launching-notification-pathway-low-risk-medical-devices-and-ivds
Brazil's ANVISA proposes updates to medical device, IVD registration requirements. Retrieved from https://www.emergobyul.com/blog/2019/10/brazils-anvisa-proposes-updates-medical-device-ivd-registration-requirements
Spring 2019 medical device regulatory recap: Brazil. Retrieved from https://www.emergobyul.com/blog/2019/04/spring-2019-medical-device-regulatory-recap-brazil
BRAZIL: new ANVISA notification pathway for class I medical devices. Retrieved from http://www.thema-med.com/en/brazil-new-anvisa-notification-pathway-for-class-i-medical-devices/
Brazil Medical Devices Market Growth Revenue and Cost Analysis with Key Company's Profiles and Forecast To 2023. Retrieved from https://www.marketwatch.com/press-release/brazil-medical-devices-market-growth-revenue-and-cost-analysis-with-key-companys-profiles-and-forecast-to-2023-2019-03-15
8 Top Growth Markets in Brazil's Health Sector. Retrieved from https://globalhealthintelligence.com/ghi-analysis/8-top-growth-markets-in-brazils-health-sector/
Brazil - Healthcare. Retrieved from https://www.export.gov/article?id=Brazil-Healthcare
O setor de Dispositivos Médicos cresceu 14,5% em três trimestres, segundo Boletim ABIIS. Retrieved from https://saudebusiness.com/voce-informa/o-setor-de-dispositivos-medicos-cresceu-145-em-tres-trimestres-segundo-boletim-abiis/
Equipamentos Médicos: mercado, inovações e tendencias. Retrieved from https://www.cobli.co/blog/equipamentos-medicos-mercado-inovacoes-e-tendencias/
Setor de equipamentos e produtos médicos cresce 14.8% segundo ABIMED. Retrieved from https://saudebusiness.com/voce-informa/setor-de-equipamentos-e-produtos-medicos-cresce-14-8-segundo-abimed/
Healthcare in Brazil - Meeting Future Challenges. Retrieved from https://home.kpmg/xx/en/home/insights/2019/04/meeting-healthcare-challenges-in-brazil.html
Brazil's 'fragile' health care gains threatened. Retrieved from https://www.hsph.harvard.edu/news/hsph-in-the-news/brazils-fragile-health-care-gains-threatened/
The Collapse of the Brazilian Health Care System. Retrieved from https://europeansting.com/2019/10/09/the-collapse-of-the-brazilian-health-care-system/
Brazil's unified health system: the first 30 years and prospects for the future. Retrieved from https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(19)31243-7/fulltext
ANVISA Launches Notification Pathway for Low-Risk Medical Devices. Retrieved from https://www.regdesk.co/anvisa-launches-notification-pathway-for-low-risk-medical-devices/