Brazil Webinar Presentation March 2012

ASIA | EUROPE | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com

Brazil’s regulatory process for medical devices

Medical Device Registration in Brazil



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



The economy is growing… As JFK said, “A rising tide lifts all boats.”



Population is growing… More people = more demand for healthcare and thus, medical devices…



And poverty is declining… And more Brazilians are able to afford healthcare.



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

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



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



• 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 Classification Class I Class II Class III Class IV

Devices are classified as Class I, II, III or IV

Increasing risk to patient or user



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



• 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 and conducted less than two years ago.

• INMETRO certification is valid for five years.

Step 3: INMETRO Product Certification



• 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



• 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



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



• 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



• 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



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



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



Brazil GMP Webinar: May 16, 2012 11am CT

An in-depth look at RDC 59/2000:

•What ANVISA inspectors look for during inspections

•Specific areas on which ANVISA inspectors focus

•Insight on ANVISA’s interpretation of the RCD 59/2000 regulations

Conducted by:

Magaly Rambousek Sr. RA/QA Consultant

Emergo Brazil

Registration price: US $199



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

Additional Resources

http://www.emergogroup.com/literature�

http://www.emergogroup.com/resources/regulations-brazil�

http://www.emergogroup.com/contact�

http://www.emergogroup.com/�



Brazil Webinar Presentation March 2012

Documents

Transcript of Brazil Webinar Presentation March 2012