Thinking about Brazil? Here’s what You Need to Know

Mark Crawford

 If you aren’t already there, maybe you should think about Brazil.

With a population of about 200 million, Brazil is one of the largest medical-device markets in the world. It has a well-developed, evolving, and fairly reasonable regulatory system in place that is similar in many ways to the EU (although it has some significant differences, too).

With an increasingly competitive global market, Brazil represents a stable, untapped market for many companies. Any company interested in expanding their product lines into Brazil will be interested in reading Underwriters Laboratories’ guide to the medical device approval process in Brazil entitled “Medical Device Approvals in Brazil: A Review and Update.”

Released in September 2011, this is an excellent overview of Brazil’s current regulatory framework and the requirements for manufacturing, importing, or selling medical devices in the country. It also discusses the registration and certification process required of all device manufacturers, importers, and distributors, and the steps necessary to secure and maintain approval for medical devices.

Resolution RDC No. 185 of October 22, 2001 is the primary regulation covering registration of all medical devices, except for in vitro diagnostic (IVD) devices, which are covered by Resolution RDC No. 206 (November 2006). The classification structure for medical devices in Brazil corresponds to that used in the European Union (EU) under Council Directive 93/42/EEC concerning medical devices.

Brazilis a member of the Southern Common Market, also known as MERCOSUR, which includesArgentina,Paraguay, andUruguay. “As such, the process for the registration of medical devices in Brazil has been partially harmonized with that of these countries, theoretically easing the process of gaining admission to these other markets,” states Underwriters Laboratories (UL).

All medical devices imported into or distributed within Brazil must first be registered with the Agência Nacional de Vigilância Sanitária, also known as ANVISA or the National Health Surveillance Agency. This agency is responsible for the registration of medical devices and for the maintenance of a registered products database. UL indicates that, “unlike the EU Notified Body system, the 510(k) system of the Food and Drug Administration (FDA) in the United States, or the Canadian Medical Device Conformity Assessment System (CMDCAS), ANVISA performs all registration and inspection functions within the agency.”  

Only companies based in Brazil can apply for ANVISA registration. That means companies that do not have subsidiaries in Brazil must depend on Brazilian-based third parties, such as hosting companies, distributors and dealers, to obtain ANVISA registration for medical devices.

The certification process starts with Instituto Nacional de Metrologia, Normalização e Qualidade Industrial, also known as INMETRO, or the National Institute of Metrology, Standardization and Industrial Quality. This group is responsible for accrediting certification organizations that certify products for compliance with applicable requirements and authorize the use of approved certification marks. This certification scheme is known as the Brazilian Conformity Assessment System (SBAC).

“To qualify for INMETRO certification, medical device manufacturers must have their products tested to SBAC-recognized standards by an INMETRO-accredited testing laboratory,” states the report.

Once a medical device has been tested to the requirements of the appropriate technical standard and all user manuals have been translated into Portuguese, an applicant can proceed with the INMETRO certification process. This involves reviewing documents, pre-license inspections, certifications, and product marketing.

After a certification body has completed its review of test reports and user manuals as well as its pre-license factory inspection, and has determined that a device and the device manufacturer are compliant with all applicable requirements, the certification body issues an INMETRO certificate (valid for five years).

“Like most other product certification systems,” states UL, “maintaining an INMETRO certification requires certain periodic activities. For an approved medical device to remain INMETRO-certified for the full five-year certification period, a manufacturer’s facility is subject to annual surveillance inspections. An annual INMETRO inspection should take place approximately 12 months after the original certification has been issued, and at succeeding 12 month intervals for the duration of the certification period.”

The current size and anticipated continued growth of the Brazilian market presents significant opportunities for manufacturers of medical devices. Brazil’s regulatory approval scheme for medical devices is similar to that found in other countries. In addition, Brazil relies on national versions of widely accepted international standards to assess product compliance.

As organized and integrated as this sounds, the length of time between filing an application for a registration of a medical device and the final government approval can be lengthy. “The International Trade Administration of the U.S. Department of Commerce estimates that it can take as little as three months or as long as two years to achieve product registration, depending on the type of submission to ANVISA, such as new registration, update, or revalidation,” says UL.

Underwriter Laboratories is an experienced and knowledgeable accredited certification body in Brazil. It has been accredited by INMETRO to evaluate and test products, devices, equipment, material, processes, and services for compliance with the standards recognized by SBAC. For more information contact Tara Kambeitz, UL’s global marketing manager for health sciences, at Tara.L.Kambeitz@us.ul.com.

Tags: brazil, global market, INMETRO, Medical device, regulatory system, SBAC