Guest Column | June 15, 2020

Understanding Medical Device Regulation In Brazil

By Julio G. Martinez-Clark, bioaccess

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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 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 to 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):

  1. 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 registration of your device and will hold the title of your registration certificate.
  2. A letter from your company authorizing its BRH to apply at Anvisa.
  3. A Certificate of Good Manufacturing Practices (GMP) obtained by successfully undergoing an Anvisa inspection. This certificate is challenging to transfer after registration.
  4. 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.
  5. A technical file and a Cadastro application.
  6. 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.
  7. If Anvisa approves the application, you will receive a number in the Diário Oficial da Uniāo (DOU). This registration does not expire.
  8. 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:

  1. 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 registration of your device and will hold the title of your registration certificate.
  2. A letter from your company authorizing its BRH to apply at Anvisa.
  3. 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.
  4. 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.
  5. A technical file, including clinical studies and information on the device, in compliance with RDC 185/2001.
  6. All files relevant to the application fee payment and the application submission to Anvisa must be in Brazilian Portuguese.
  7. 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.
  8. 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.).

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[Editor’s note: References are included below for both articles in the series]

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