1. The regulatory road to market
Brazil Regulations Update
Qserve Conference 18-19 November 2013
Purmerend – Greater Amsterdam
Page 1 | 2011 |Copyright Qserve Group B.V.

2. Agenda
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Geography
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Key developments in Brazil
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Health care system
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Regulatory process for medical devices in Brazil
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Validation compliance
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Additional remarks
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Summary/main conclusions
Page 2 | 2013 |Copyright Qserve Group B.V.

3. Geography
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Brazil is largest country in South
America, 5th largest in the world
Population of 200 Million 5th largest
worldwide
Capital is the city of Brasília, main cities
are:
 São Paulo ( 11 Million citizens )
 Rio de Janeiro (6 Million citizens)
Brazil is ruled by the Federal Presidential
Representative Democratic Republic
6th largest economy in 2012.
GDP : US $ 12.800 , growth: 2,34 %
( Netherlands: US $ 42.300,-)
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4. Key developments in Brazil

5. Key developments in Brazil
Strengths
Weaknesses
• Positive economic conditions in the recent
years.
• Increased consumption power by C/D class.
• Low risk country (ranked as 3rd most
attractive country for foreign investment).
• Adaptability, creativity and flexibility.
• Empire of laws / heavy bureaucracy,
enormous public spending.
• Corruption incentive due to customs , tax &
legal system.
• Regional inequalities.
• Structural barriers to growth.
Opportunities
Threats
• Economic development forcing reforms.
• FIFA World Cup in 2014, Olympic Games in
2016 and Pre Salt development (Brazil as the
6th world major oil reserve) will ramp
investments in infra-structure.
• World player ambitions demand open
economy.
• Brazil will be the China (GDP growth
velocity) of the next decade (2010-20),
becoming the #5 world’s economy.
• Possible Global Recessions.
• Low pace of reforms bottlenecks economic
growth.
• China dependency.
Page 5 | 2013 |Copyright Qserve Group B.V.

6. Health Care System in Brazil
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Largest medical device market in Latin America.
The public health system (SUS), provides healthcare services for all Brazilians
citizens
The majority of inpatient services within the SUS are operated by private
providers, with more than two-thirds of hospital facilities operated by the
private sector.
Brazil has the second largest private health insurance sector in the Americas,
after the USA, covering around 25% of the population
The expansion of the private health insurance sector in recent years has resulted
in demand for better medical care and, in turn, further expenditure in medical
equipment.
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7. Health Care System in Brazil
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Private investment being encouraged through a public-private partnerships
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Public sector continues to be modernized and to upgrade
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The government is extending healthcare service access through its Mais Saúde
programme.
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Invest in SUS expanding: 2013: Reais 2.3 billion (US$1.1 billion) to support the
development of primary health and emergency care services.
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8. Health care system in Brazil
The development of the economy is forcing reforms to improve and provide a good
health system to all people covering the whole country and not only the major
economic centers as Sao Paulo and Rio de Janeiro.
Page 8 | 2013 |Copyright Qserve Group B.V.

9. Regulatory process for medical devices in Brazil
National Health Surveillance Agency
National Institute of Metrology,
Standartization and Industrial Quality
Registration of medical devices and
maintenance of a registered products
database Brazilian GMP audit
National accreditation body.
Some electronic medical devices
must obtain INMETRO
certification as part of the
Brazilian registration process.
Page 9 | 2013 |Copyright Qserve Group B.V.

10. Regulatory processes in Brazil

Medical Device Classification – RDC 185/01 is the primary regulation applicable
to the registration of all medical devices, risk based classification, subdivided in
four classes similar to the Annex IX 93/42/EEC
RDC 185/01
I
II
III
IV
93/42/EEC,
Annex IX
I
IIa
IIb
III
 RDC No. 185 describes
the applicable device registration protocol and lists the
documents required to legally register a medical device in Brazil.

Early classification of medical devices required
Page 10 | 2013 |Copyright Qserve Group B.V.

11. Regulatory processes in Brazil
Appoint Brazilian Registration Holder
Who you can use to be your BRH?
set up your own company
use a distributor
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use an independent firm
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Responsibilities of BRH
Provide authorization as local entity
on the device registration to Anvisa
Request the GMP inspection, if
applicable
Submit GMP self-inspection reports, if
applicable, to Anvisa
Hold INMETRO certificates
Give permission for distributors to
import products
Coordinate inquiries, analysis and
response for reportable events and
recalls
Assist in renewal and modifications of
device registrations
Page 11 | 2013 |Copyright Qserve Group B.V.

12. Regulatory processes in Brazil
ANVISA´s GMP INSPECTION
 Manufacturer must submit application for ANVISA´s GMP inspection
 Payment of fee in advance: R$ 37.000,00 (approximately US $ 16.500,00) per
site
 New regulation: Publication of RDC 16/13 covering ANVISA´s GMP
requirements for Medical Devices and IVDs
 RDC 16/13 replaces RDC 59/00 and Portaria 686 (IVDs)
 GMP inspections are mandatory for manufactures of class III and IV devices
and class I/II devices listed in IN2/11
 Once GMP compliance has been established, ANVISA conducts GMP
inspections every two years.
 Manufacturers must self-audit every alternating year and submit report to
Anvisa
 ANVISA registrations are valid for five years.
 Audit are currently only performed by ANVISA – no Third Party authorized
Page 12 | 2013 |Copyright Qserve Group B.V.

13. Regulatory processes in Brazil
ANVISA´s GMP INSPECTION
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Queue time for Anvisa´s GMP inspection is currently about 2 years
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After successful inspection, Anvisa issues an Inspection Certificate which is
prerequisite for later medical device registration
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Manufactures of Class I and II devices not listed in IN 2/11 are exempt from
Brazilian GMP inspections
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Market access according to the Cadastro Process RDC 24/09
Page 13 | 2013 |Copyright Qserve Group B.V.

14. Regulatory processes in Brazil - INMETRO
Certification

Mandatory INMETRO certification
for most electrical Medical
Devices under the scope of
standards as listed in IN 3/11 mostly similar IEC or ISO

INMETRO Exemptions
Medical devices for which no test
capabilities within Brazil are available
such as Magnetic Resonance Devices
and Computer Tomography Scanner
standards

Some none electrical medical
devices
e.g. Gloves, Male Condoms, infusion
sets, needles , syringes
Page 14 | 2013 |Copyright Qserve Group B.V.

15. Regulatory processes - INMETRO Certification
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Test report must not be older than 2 years – Ordinance 350/10
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Must be completed prior to registration at ANVISA – RDC 27/11
After successful completion of Documentation Review and Pre-license
Inspection, certification is accepted
Annual factory inspection in order to maintain INMETRO Certification
INMETRO Certifications is valid for 5 years
For Re certification after 5 years, the Medical Device has to be completely retested even if it has not been changed
Page 15 | 2013 |Copyright Qserve Group B.V.

16. Regulatory processes – Anvisa Registration
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Prerequisites
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Manufacturing Description - Flow Chart
ANVISA´s Inspection Certificate
INMETRO Certificate – if applicable
Complete set of documentation according to RDC 185/01
Content of documentation according to RDC 185/01
Registration Form
Instructions for use in Portuguese
Technical Report: technical and scientific data regarding device safety
Manufactures letter authorization for a Brazilian legal entity to register, import
and distribute the product
Page 16 | 2013 |Copyright Qserve Group B.V.

17. Regulatory processes – Anvisa Registration
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Clinical Data, can be clinical trials or literature depending on the risk

Proof of home market approval / Free sales Certificate
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Alternatively proof of two other marketing approvals and explanation for no
home market approval

List of all accessories

Economic Information Report can also be required for some medical devices,
(cardiovascular products, implantable medical devices), information about
lifetime, pricing in other markets, number of patients per year – RDC 185/06

Specific documentation regarding the device can also be requested by ANVISA
Page 17 | 2013 |Copyright Qserve Group B.V.

18. Regulatory processes – Anvisa “Cadastro”
Manufactures of Class I and II devices not listed in IN 2/11 - RDC 24/09
 Registration Form
 Technical Report
 Payment of fee
 Timeline: approx.. 3months
Page 18 | 2013 |Copyright Qserve Group B.V.

19. Timelines
INMETRO Certification
About 1/2 month's
Lead Time Anvisa Inspection up to
24 months
Time between application for
GMP Inspection and execution of
inspection / issuance of certificate
by Anvisa
Anvisa Review
Time up to 12
months
(depending on
classification, risk,
complexity of product)
Page 19 | 2013 |Copyright Qserve Group B.V.

20. Additional remarks
Brazilian medical device market regulator ANVISA plans to
launch a two-year trial period to allow third-party audits of
Brazilian Good Manufacturing Practice (B-GMP) quality
systems.
ANVISA has set a tentative
start date of January 2014
for the trial; the US,
Canada, Brazil and
Australia are expected to
participate, meaning that
third-party certifiers
would be able to audit a
manufacturer’s quality
system for US, Canadian,
Brazilian and Australian
requirements at the same
time.
Although third-party
inspectors will be able
to perform B-GMP
audits, they will not
issue B-GMP
certificates. The
inspectors will instead
provide reports to
ANVISA, and the
regulator will then issue
final certification to the
manufacturer in
question.
This auditing program is
intended to be an additional
option for companies that
require B-GMP quality
management
System inspections; the
“normal” process of
requesting and receiving
inspections directly from
ANVISA will continue to be
available
Page 20 | 2013 |Copyright Qserve Group B.V.

21. Validation compliance Brazil
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A new Good Manufacturing Practices regulation, RDC 16/2013, replaces two prior
BGMP resolutions, RDC 59/2000 for medical devices and Ordinance 686/1998 for in
vitro diagnostic (IVD) devices
Classification has impact on timeline: Complete registration process or cadastro
When applying for ANVISA GMP Inspection, the time on line has to be considered
ANVISA has published RDC 39/2013, issuing GMP certificates as well as Certifications
of Good Distribution Practices.
In addition, RDC 39/2013 allows foreign companies to change addresses of facilities
listed in applications for GMP certification, provided their applications have not yet
been reviewed by ANVISA.
INMETRO Safety certification for medical devices with electrical and other
components has changed in Brazil.
Foreign manufactures in the process of appointing BRH partners for devices that
must undergo INMETRO testing and certification should therefore verify that any
potential in-country representation partner can properly obtain INMETRO
certification as well as manage ANVISA registration
Page 21 | 2013 |Copyright Qserve Group B.V.

22. Summary/main conclusions
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Current size and anticipated continued growth of the Brazilian market present
significant opportunities for manufacturers of medical devices.
The length of time between filing an application for a registration of a medical
device and the final government approval can be lengthy.
Medical device manufacturers can ease the process of gaining access to this
lucrative market by understanding the similarities and differences between
Brazil’s medical device approval scheme and the ones used in other major
markets. Staying informed of anticipated changes in regulations provide valuable
time to develop alternative plans and strategies for gaining and maintaining
market access.
Finally, working with an experienced and knowledgeable company in Brazil can
smooth the compliance process and mitigate setbacks from unanticipated issues
and challenges.
Page 22 | 2013 |Copyright Qserve Group B.V.

23. Thank you for your attention !
Sheila Jaime
sheila.jaime@qservegroup.com
www.qservegroup.com
Qserve Group B.V.
Asterweg 19 D12
1031 DL Amsterdam
The Netherlands
T +31 (0)20 78 82 630
E info@qservegroup.com
Page 23 | 2013 |Copyright Qserve Group B.V.