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Brazil’s regulatory process for medical devicesMore about Emergo Group's services in Brazil:http://www.emergogroup.com/services/brazil
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ASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
Brazil’s regulatory process for medical devices
Medical Device Registration in Brazil
ASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
Brazil’s regulatory process for medical devices
Is Brazil a good market to enter?
•Brazilian GDP will grow by 4.5% in 2011 and 4.0% in 2012
•Brazil’s nominal GDP per Capita will reach $12,990 in 2011 and $13,193 in 2012
•Brazil’s economy is now the world’s seventh-largest, ahead of Spain and Italy
Source: Goldman Sachs Global Economics, Commodities and Strategy Research
ASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
Brazil’s regulatory process for medical devices
The economy is growing…As JFK said, “A rising tide lifts all boats.”
ASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
Brazil’s regulatory process for medical devices
Population is growing…More people = more demand for healthcare and thus, medical devices…
ASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
Brazil’s regulatory process for medical devices
And poverty is declining…And more Brazilians are able to afford healthcare.
ASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
Brazil’s regulatory process for medical devices
Snapshot of Brazil’s device market• Brazilian medical device sector totaled
$4.8 billion in 2010, a 200% increase from 2003.
• Brazil imported $3.7 billion in medical equipment in 2010.
• In 2010, laboratory equipment constituted largest share of imports into Brazil ($884 million), followed by consumables ($767 million), medical and hospital equipment ($726 million) and radiological equipment ($681 million).
Source: www.brazilianhealthdevices.com/en/market
ASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
Brazil’s regulatory process for medical devices
Before you begin…You must obtain a device registration certificate or certificate of free sale (CFS), or acceptable substitute, proving your product is approved for sale in your home market.
Acceptable documents:
• CFS from Home Market, consularized by Brazilian consulate• INMETRO Certificate• Proof of Marketing Approval in two other countries
ASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
Brazil’s regulatory process for medical devices
• A smooth registration process in Brazil begins with properly classifying your medical device using rules found in Brazilian Resolution RDC 185/01 published by Brazilian medical device regulator ANVISA
• Brazilian Resolution RDC 185/01 is fashioned similarly to the European Medical Device Directive (93/42/EEC)
• Classes I, II, III and IV in Brazil are similar to Classes I, IIa, IIb and III in the European Union
Step 1: Determine Device ClassificationClass I Class II Class III Class IV
Devices are classified as Class I, II, III or IV
Increasing risk to patient or user
ASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
Brazil’s regulatory process for medical devices
Manufacturers with no local presence in Brazil must appoint a Brazil Registration Holder (BRH) to control registration of
their devices and liaise with ANVISA.
Step 2: Appoint Brazilian Registration Holder
• Your BRH must hold a Company Working Allowance permit (IN 01/94) from ANVISA
• These permits allow your BRH to import, distribute and sell your product in Brazil
• Manufacturers do not need to obtain permits themselves
ASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
Brazil’s regulatory process for medical devices
• Some electronic medical devices must obtain INMETRO certification in accordance with RDC 27/2011 as part of the Brazilian registration process.
• Electrical safety testing conducted outside Brazil is acceptable if testing was performed by an International Laboratory Accreditation Program (ILAC)-certified laboratory andconducted less than two years ago.
• INMETRO certification is valid for five years.
Step 3: INMETRO Product Certification
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Brazil’s regulatory process for medical devices
• Some Class I and II manufacturers and all Class III and IV manufacturers must comply with Brazilian Good Manufacturing Practice (BGMP) quality system requirements
• BGMP requirements are specified by RDC 59/2000• Brazilian quality system requirements resemble those of US
Quality System Regulation 21 CFR Part 820• Once BGMP compliance has been established, ANVISA
conducts BGMP inspections every two years. • Manufacturers must self-audit every alternating year.
Step 4: BGMP Compliance
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Brazil’s regulatory process for medical devices
• Normative Instruction IN 2/2011 lists Class I and Class II devices that must obtain BGMP certification
• Class I and II devices not listed on IN 2/2011 are not required to obtain BGMP certification
• Qualifying firms go through an abbreviated review process and do not have to undergo BGMP re-certifications or pay associated fees
BGMP Exemptions
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Brazil’s regulatory process for medical devices
ANVISA requires Economic Information Reports (EIRs) for some devices in accordance with RDC 185/06. EIRS include:
Pricing comparisons for other markets Patient/user information
Marketing materials Other materials
Clinical trials: High-risk and innovative devices must meet ANVISA clinical trial requirements. ANVISA usually accepts clinical trial results previously conducted in other markets as adequate to meet such requirements.
Step 5: Economic Information Reports and Clinical Trial Requirements
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Brazil’s regulatory process for medical devices
• Technical files required by ANVISA resemble documents required by the US FDA
• Technical files should be prepared according to RDC 185/01 Annex III Part A/B/C and provided in Portuguese
• Technical files should include information on device safety and effectiveness as well as product design data
• Meet ANVISA labeling requirements, labelling must be provdied in Portuguese
• Firms that have already prepared Technical Files for CE Marking or US FDA 510(k) clearance may usually reuse that information to prepare their Brazilian Technical Files.
Step 6: Technical File Preparation
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Brazil’s regulatory process for medical devices
• Your Brazilian Registration Holder begins the process by submitting your registration application and Technical File to ANVISA.
• Registration fees are due to ANVISA upon submission of your application and Technical File documents.
• The device registration process is controlled by your BRH.
Step 7: Submit Registration Application to ANVISA
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Brazil’s regulatory process for medical devices
Step 8: ANVISA Review and Approval• ANVISA registration reviews can take six to 12 months for Class I, II and III devices, and longer for Class IV devices•ANVISA registrations are valid for five years.
Upon approval,
ANVISA will publish your
device’s registration
number in the Diário Oficial
da União
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Brazil’s regulatory process for medical devices
Ongoing Compliance Issues
•ANVISA conducts on-site BGMP audits every two years
•During off years, manufacturers must conduct self-inspections and submit reports to ANVISA
•Both ANVISA device registrations and INMETRO certifications must be renewed every five years
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Brazil’s regulatory process for medical devices
PDF Chart of Brazil’s Regulatory Process:http://www.emergogroup.com/literature
List of Brazilian regulatory documents: http://www.emergogroup.com/resources/regulations-brazil
Thank you for your time!
List of all global offices: www.emergogroup.com/contact
EmergoGroup.com
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