MedicalDevice
Certificationin Brazil

Expertise and experience
Electro-medical device product certification in Brazil

Brazil is one of the most interesting
new export markets for medical device
manufacturers in North America, Europeand Asia. As one the BRIC economies(Brazil, Russia, India and China) it represents
significant market growth opportunities.
In surveys, over the last three years, Brazil
has been consistently identified by medical
device manufacturers as a top new market toconsider for their medical devices.

Our mission is to ensure
patient safety while supporting timely
access to global medical device
technology. We strive to set the global
standard in thorough, responsive,predictable conformity assessments,evaluations, and certifications.

Brazilian Medical Device Regulations
All medical devices in Brazil are regulated by the Brazilian Health
Surveillance Agency (ANVISA), medical devices are classified
according to their risk, Class I (low risk) to Class IV (high risk). NonBrazilian manufacturers need a local Brazilian Registration Holder(BRH) based in Brazil.
ANVISA requires that all devices must complete a device registration
process, this includes submitting a technical file to ANVISA throughyour BRH. All of your manufacturing locations must comply with
Brazilian GMP (RESOLUÇÃO DA DIRETORIA COLEGIADA - RDC N°16,
Brazilian regulations similar to ISO 13485).
BSI will soon qualify to conduct Brazilian GMP inspections under the
Medical Device Single Audit Program (MDSAP) initiative.
ANVISA conducts the technical file review and issues the registration.

Electro-Medical Devices
IEC 60601 is the international standard for safety of electro-medical
devices. Electro-medical devices entering Brazil require a mandatory
INMETRO* IEC 60601 product certification, this must be completed
before applying for ANVISA registration. BSI Brazil is accredited byINMETRO to issue IEC 60601 Product Certification.
All electro-medical manufacturers must have a local representativethat will apply for product certification. Medical devices must
be tested to IEC 60601 and the relevant parts of the standard,
manufacturers will audited by the INMETRO Product Certification
Body or their approved agent, product certification is issued for up
to five years.
* INMETRO is the national accreditation body for testing, certificationand system assessment.

BSI INMETRO IEC 60601 Product Certification Process
The table shows the overview of the certification process, for full details, please contact BSI via the details on the back page

Certification steps

Phase

ObjectiveResponsible

1

Quotation proposal request

Collect basic client andproduct data

BSI Sales

2

Initial review

Confirm certification viabilityand review audit days

BSI Brazil Reviewer

3

Quotation and Certification
Agreement

Establish a contract.
Collect product tests data

BSI Sales

4

Initial product review andFactory Audit planning

Complete Product Test Records
Review; plan Factory Audit

BSI Brazil Reviewer(stage 1)

5Conduct factory audits

Review QMS, routine tests,
product/process verification

BSI Auditor(stage 2 and CAVs)

6

Final product andFactory review

Perform certification

BSI Brazil Reviewer makes recommendation
to BSI Certification Committee

BSI Brazilian Medical Device Regulations

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Product Documentation

Audit of Manufacturer, Stage II

Product documentation required at Stage 1 includes:

Predictable, reliable service consistent with other BSI Healthcare
services (CE and ISO 13485)

1. The applicable quality management system documents, such as
quality manual;
2. Confirmation of the Routine Tests applied to the product, seebelow;
3. The Type Tests Report performed on the latest version of theproduct, by a valid Accredited Laboratory, within the last 2 years.
Routine Tests
Ongoing tests performed on each produced unit, during or after
manufacturing, normally within the manufacturers facility, to confirm
compliance with the minimum test requirements defined in IEC
60601-1: 2005, including:a Equipment Operation;b Protective earthing, functional earthing and potential equalization(see IEC 60601-1: 2005 clause 8.6)

c Leakage Currents and Patient Auxillary Currents• Assessment of the quality management system in accordancewith ISO 13485 requirements, particularly in relationship to theproduct(s) undergoing product certification.
• Confirmation that the agreed Routine Tests are performed in 100%of the manufactured units.
• Product and process audit, related to the certification scope, of themanufacturing processes to confirm effective methods, controls,infrastructure, verifications, people, etc are in accordance with thedeclared and planned arrangements.
• Verification that Design Historical Record and Device Master
Record are in-place, maintained and in use.
• As appropriate review of previous quality management system
audit records performed by a Product Certification Body or
Regulatory Agencies (such as ANVISA), and the corrective actions
records for nonconformities identified.

(see IEC 60601-1: 2005 clause 8.7)

d Insulation, Dielectric Strength (see IEC 60601-1: 2005 clause 8.8.3)• The product sampling and selection criteria, if type tests have notyet been performed.

Valid laboratory accreditations for Type Testing Reportd ILAC – International Laboratory Accreditation Co-operation.

'Out of the 25 global medical device
manufacturers, 23 organizations selected
BSI as their trusted partner for CE marking
certification against the EU directives.’

What this means for You

Why talk to BSI?

For the evaluation of the quality management system in accordancewith ISO 13485 requirements, if you have a current ISO 13485
certified under Cgcre/INMETRO accreditation (or other IAFaccreditation), or ANVISA RDC 16, BSI may waive the necessity torepeat the management system verification in each Factory Audit if:• Predictable, reliable service consistent with other BSI Healthcare

a INMETRO Laboratory accreditation (preferable);b IAAC – Inter-American Accreditation Co-operation;c EA – European Accreditation for Co-operation;• The management system certification scope covers all products
applied for IEC 60601 product certification• The last management system audit indicates that all ISO 13485
requirements related were covered into the audit.
CAV duration may change from time to time based on the changeof manufacturing site size, product design changes and technology
changes of production process. Extraordinary audits may be required
if technical circumstances justify. For CAVs, the Audit shall include
the verification of the usage of the BSI Assurance Mark.

BSI Brazilian Medical Device Regulations

services (CE and ISO 13485)• Knowledgeable product and certification local experts within BSIBrazil• Single point of contact with a BSI local account manager forquotations and managing applications• Possibility to roll/combine annual INMETRO Product Certification
audits into regular ISO 13485 / CE Marking audits• Efficient/timely BSI Brazil certification• Global recognition and confidence in BSI provides confidence inthe manufacturer and their device• BSI will be conducting MDSAP audits in the future that will berecognized by ANVISA.

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BSI as the industry thought leader
Here to help you:

BSI Medical Devices - Interfacing with
the Regulatory Authorities and Lobbying• We have 2,900 members of staff,• BSI have representations on the following world• 65 BSI offices around the world,

leading associations• 70,000 clients operating in 150 countries,• NB-Med Notified Body Forum,• Together our clients account for 54% of the FTSE 100,

• Team-NB

40% of the Fortune 500 and 24% of the Nikkei listedcompanies,• We are one of the world’s largest independent• Regulatory Affairs Professionals Society (RAPS)• The Organisation Professional Regulatory Affairs,

certification bodies for management systems, with over
90,000 registered sites across the globe.

Three unique reasons to let BSI help you
Experience:
We have a wealth of experiencein helping medical device
manufacturers achieve their
Global access goals, with aspecialist local presence you
can rely on.

Expertise:
Local experts to deal directlywith ANVISA and INMETRO,
keeping you closer to themarket and decisions.

Market Access:
At BSI we understand theimportance for companieswishing to sell into newmarkets. Our Brazilian focus
will help you to stay aheadof the competition.

BSI Brasil Sistemas de Gestão Ltda.
Rua Gomes de Carvalho,1069-18 floor
Vila Olimpia - Sao Paulo / SP
CEP: 04547-004

Contact:
T: 11 2148-9600
F: 11 2148-9601
E: bsibrasil@bsigroup.com

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other countries throughout the world.

Visit us online at: medicaldevices.bsigroup.com© BSI Group

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