Brazil’s Regulatory System: A Primer

Among emerging medical device markets worldwide, Brazil has become a high-priority target for many foreign manufacturers due to its sheer size as well as its stable regulatory system.

Brazil boasts the largest Latin American medical device market, with revenues of $4.8 billion as of 2010, and the country’s medical device imports have risen at a steady pace—more than $4 billion in 2011, up from $3.7 billion in 2010 and $2.8 billion in 2009.1 Unlike some emerging medical device markets, however, Brazil also features a robust and active regulatory framework managed by the National Health Surveillance Agency, or ANVISA. All medical device manufacturers must register with ANVISA prior to marketing their devices in the country, which requires considerable effort on the part of companies and sponsors. In addition, foreign manufacturers should appreciate that Brazil has a fairly sizeable domestic medical device sector that exports to other North and South American markets.

Brazil’s Registration Process: Initial Steps
Medical device registration according to ANVISA requirements begins with the classification of a product.

Brazil has a four-tier, risk-based classification system (Class I, II, III and IV). AVISA’s Brazilian Resolution RDC 185/01 Annex II contains rules manufacturers should use in order to properly classify their devices according to Brazilian standards.

Accurate classification is essential to determine the proper ANVISA regulatory pathway. Some Class I and II devices qualify for the simplified cadastre process rather than the standard registration process. This process entails having to provide less information to ANVISA for your device, as well as shorter review times.

In-country representation also is required of foreign manufacturers that have no local presence in Brazil. A foreign firm must appoint an in-country representative (known as a Brazilian Registration Holder or BRH) at the beginning of its registration process. Responsibilities of the BRH include controlling the registration process locally in Brazil as well as liaising on the company’s behalf with Brazilian regulators. It is critical to ensure that the BRH has a valid Company Working Allowance permit in accordance with IN 01/94, which authorizes the BRH to import, distribute, sell and store products in Brazil.

Electrical safety testing and certification also may be required for some medical devices with electrical components. Testing and certification are conducted by Brazil’s National Institute of Metrology, Quality and Technology (INMETRO) laboratories according to RDC 27/2011, but in some instances ANVISA will accept electrical safety testing conducted outside Brazil. In order to qualify for this allowance, a company’s device testing must be less than two years old and from an International Laboratory Accreditation Cooperation (ILAC)-certified laboratory.

Next, you must determine whether your device requires an Economic Information Report based on RDC 185/06 mandates. An Economic Information Report contains price comparisons for other countries, patient or user information and device marketing materials that include:

• Device pricing in other markets;
• Potential number of patients using your device in Brazil;
• Planned price in Brazil for your device; and
• List of comparable products along with their prices.

ANVISA also may require clinical data for high-risk and innovative medical devices, but results of clinical trials conducted in other markets often are acceptable to Brazilian regulators.

Quality System Requirements: B-GMP
Following classification and BRH selection (as well as INMETRO certification, if necessary), manufacturers must ensure compliance with Brazilian quality management system (QMS) requirements.

Although most emerging market regulators recognize U.S. Food and Drug Administration (FDA) Quality System Requirements compliance or ISO 13485 certification, Brazil has established its own QMS—Brazilian Good Manufacturing Practice (B-GMP).

All Class III and IV medical devices, as well as Class I and II devices listed in Normative Instruction (IN) 2/2011, must comply with B-GMP. Although B-GMP requirements resemble those of the FDA’s Quality System Requirements, manufacturers should not assume that FDA compliance translates seamlessly to B-GMP compliance. Manufacturers formerly were subject to B-GMP quality system inspections and fees on an annual inspection schedule. Now, B-GMP inspections are conducted on a biennial basis.
(During off years, manufacturers must conduct internal quality inspections and submit results to ANVISA.) Class I and II devices that do not appear on IN 2/2011 do not require B-GMP certification; manufacturers of these devices thus face lower compliance costs because they do not have to deal with the expenses of quality system implementation and ANVISA inspections.

Manufacturers should be aware that there currently is a two-year lead time for GMP inspections, and therefore should plan accordingly. ANVISA currently is processing GMP requests from June 2010.

Technical File Preparation
Once your company’s B-GMP quality system is in place, you must prepare a technical file for submission to ANVISA. Documentation necessary for a technical file includes technical and scientific data regarding device safety, information on your manufacturing process, information on any laboratory tests conducted on your device, as well as device design, materials and functionality data. Proposed labeling and indications for use for the device also must be provided along with the technical file. All documentation submitted to ANVISA must be in Portuguese (Brazil’s official language).

Along with your technical file, a Certificate of Free Sale (CFS) or other device registration certificate from your device’s country of origin must be provided to your BRH. If you cannot provide a CFS from your home market to ANVISA, proof of marketing approval from two other medical device markets along with reasons stating why your product does not yet have clearance or approval in its home market must be submitted. In addition, a letter of authorization to your BRH must be provided. The BRH then submits the registration application and technical file to ANVISA on the company’s behalf for review.

Final Approval from ANVISA
If ANVISA reviewers accept your registration application, the regulator then publishes the official registration number of your device in its Diário Oficial da União (commonly referred to as the DOU); your ANVISA registration is valid for five years. Timeframes for ANVISA approvals depend significantly on the classification of your device: lower-risk cadastre applications typically take three to four months to process, while Class III and IV device applications can take from six to 12 months to review. Please note, however, that device applications cannot be submitted until a B-GMP certificate is issued. These two steps cannot be completed concurrently and must be completed one after the other.

Post-Market Requirements
As in many other developed and emerging markets, Brazil’s medical device regulators require post-market surveillance once a product is commercialized in the country. ANVISA post-market requirements are on par with those in markets such as the European Union. Your BRH must maintain records on your device and notify Brazil’s National Health Surveillance System of any adverse events, recalls or major health threats tied to the device.

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Reference:

1. http://brazilianhealthdevices.com/en/market

Stewart Eisenhart is regulatory editor and Evangeline Loh, Ph.D., RAC, is vice president of regulatory affairs for Emergo Group. Emergo, based in Austin, Texas, is an international medical device consulting firm that provides regulatory, quality assurance and distribution consulting services. Evangeline can be reached at [email protected].