Brazil represents a large market opportunity for medical device manufacturers, with over 195 million people and a mature healthcare system. However, manufacturers must navigate Brazil's evolving regulatory approval system, including mandatory device registration. This document provides an overview of the key Brazilian regulatory and certification bodies, including INMETRO, ANVISA, and ANATEL. It also outlines the certification schemes and labeling programs manufacturers must follow to access the Brazilian market, such as mandatory, voluntary, energy efficiency, and noise certifications. Partnering with an expert certification laboratory is recommended to help navigate these requirements.
Theory and fundamentals of Active Chilled Beams presented at the Illinois Chapter of ASHRAE, February 8, 2011. Presented by Matt Green of Thermosystems.
This is a presentation on the country, India. India, officially the Republic of India (Hindi: भारत गणराज्य is a country in South Asia. It is the seventh-largest country by geographical area, the second-most populous country, and the most populous democracy in the world. Bounded by the Indian Ocean on the south, the Arabian Sea on the west, and the Bay of Bengal on the east, India has a coastline of 7,517 kilometres (4,700 mi).It is bordered by Pakistan to the west;People's Republic of China, Nepal, and Bhutan to the north; and Bangladesh and Myanmar to the east. India is in the vicinity of Sri Lanka, the Maldives, and Indonesia in the Indian Ocean.
Its capital and largest city is Chennai (formerly known as Madras). Tamil Nadu lies in the southernmost part of the Indian Peninsula and is bordered by the union territory of Puducherry and the South Indian states of Kerala, Karnataka, and Andhra Pradesh.
Visit to Uttar Pradesh - The Heart of IndiaThe Other Home
Uttar Pradesh, abbreviated U.P., is a state located in northern India. It was created on 1 April 1937 as the United Provinces with the passing of the States Reorganization Act and renamed Uttar Pradesh in 1950. Tour To U.P. with Theotherhome.com
Theory and fundamentals of Active Chilled Beams presented at the Illinois Chapter of ASHRAE, February 8, 2011. Presented by Matt Green of Thermosystems.
This is a presentation on the country, India. India, officially the Republic of India (Hindi: भारत गणराज्य is a country in South Asia. It is the seventh-largest country by geographical area, the second-most populous country, and the most populous democracy in the world. Bounded by the Indian Ocean on the south, the Arabian Sea on the west, and the Bay of Bengal on the east, India has a coastline of 7,517 kilometres (4,700 mi).It is bordered by Pakistan to the west;People's Republic of China, Nepal, and Bhutan to the north; and Bangladesh and Myanmar to the east. India is in the vicinity of Sri Lanka, the Maldives, and Indonesia in the Indian Ocean.
Its capital and largest city is Chennai (formerly known as Madras). Tamil Nadu lies in the southernmost part of the Indian Peninsula and is bordered by the union territory of Puducherry and the South Indian states of Kerala, Karnataka, and Andhra Pradesh.
Visit to Uttar Pradesh - The Heart of IndiaThe Other Home
Uttar Pradesh, abbreviated U.P., is a state located in northern India. It was created on 1 April 1937 as the United Provinces with the passing of the States Reorganization Act and renamed Uttar Pradesh in 1950. Tour To U.P. with Theotherhome.com
Cavitation Technologies, Inc develops, manufactures, and
commercializes disruptive patented nano technology fluid
dynamics systems geared at reducing the environmental
impact of industry. The Company aims to embody a global
role as an ESG technology leader.
First, I would like to thank the conference organizers for inviting me to speak on a subject so critical for global economies and the quality infrastructure community.
Cavitation Technologies, Inc. (CTi) is a “Clean-Tech” company developing and marketing new cutting edge technologies to lessen the environmental impact of large-scale industrial liquid-processing industries such as water treatment, vegetable oil refining, renewable fuels, and alcoholic beverages.
Part two of the compliance webinar series will be about customizing your solution to meet your specific needs in compliance. This will include the use of process extension and data import tools that assist with bringing all your compliance information into the Agile system.
overview of Anvisa Requirements, Medical device classification and grouping, cadostro registration pathway,resgistro pathway,INMETRO Certification, Summary of Anvisa Registration Process
In this presentation we want to outline the principles of medical device regulations and the 510(k) Premarket notification process for an efficient product approval with the FDA.
We are happy to share with you, our monthly News letter “Tech-Talk” which is designed tobe an emental source for leading information related to developing technologies, ingenious techniques and innovative approaches.
Similar to Intertek your guide-to_brazil_market_access your guide to brazilian (20)
Fundamentos necessários para que os usuários iniciem o processo de cotação usando a plataforma Salesforce. Ele levará mais de uma hora para ser concluído e permitirá que os usuários comecem a executar o CPQ aprendendo métodos de precificação, modelo de dados de objeto do CPQ, configuração técnica de descontos, documentos de saída.
The Salesforce Automation Landscape
The Salesforce Automation Landscape
Declarative Tolls points and clicks admins
Coding tools Salesforce Gods
For Developers it is very important understand
the tools available and know when they should be applied.
Declarative tool set – Workflowrules, same object updates
Email notifications, limited applications.
Process Builder – Related object updates
Create a records, no unrelated objects
Bulk issues everywhere
Visual flow unrelated object updates variables and loops.
Same learning curve as code, but without the benefits.
A high-level overview of the key features and benefits of Workflow and Approval process automation in Enterprise Edition. Your sales force operates more efficiently with standardized internal procedures and automated business processes. Many of the tasks you normally assign, the emails you regularly send, and other record updates are part of an organization's standard processes. Instead of doing this work manually, you can configure workflow and approvals to do it automatically.
Begin by designing workflow rules and approval processes, and associating them with actions such as email alerts, tasks, field updates, or outbound messages.
Migrating
your
existing applications and IT assets to the Amazon Web Services
(AWS)
Cloud
presents
an opportunity to transform the way your organization
does
business.
It can help
you
lower costs, become more agile, develop new
skills
more quickly
, and deliver reliable, globally available services to your
customers.
Our goal is to help you to
implement
your cloud strategy
successfully.
The world of search engine optimization (SEO) is buzzing with discussions after Google confirmed that around 2,500 leaked internal documents related to its Search feature are indeed authentic. The revelation has sparked significant concerns within the SEO community. The leaked documents were initially reported by SEO experts Rand Fishkin and Mike King, igniting widespread analysis and discourse. For More Info:- https://news.arihantwebtech.com/search-disrupted-googles-leaked-documents-rock-the-seo-world/
LA HUG - Video Testimonials with Chynna Morgan - June 2024Lital Barkan
Have you ever heard that user-generated content or video testimonials can take your brand to the next level? We will explore how you can effectively use video testimonials to leverage and boost your sales, content strategy, and increase your CRM data.🤯
We will dig deeper into:
1. How to capture video testimonials that convert from your audience 🎥
2. How to leverage your testimonials to boost your sales 💲
3. How you can capture more CRM data to understand your audience better through video testimonials. 📊
Putting the SPARK into Virtual Training.pptxCynthia Clay
This 60-minute webinar, sponsored by Adobe, was delivered for the Training Mag Network. It explored the five elements of SPARK: Storytelling, Purpose, Action, Relationships, and Kudos. Knowing how to tell a well-structured story is key to building long-term memory. Stating a clear purpose that doesn't take away from the discovery learning process is critical. Ensuring that people move from theory to practical application is imperative. Creating strong social learning is the key to commitment and engagement. Validating and affirming participants' comments is the way to create a positive learning environment.
What is the TDS Return Filing Due Date for FY 2024-25.pdfseoforlegalpillers
It is crucial for the taxpayers to understand about the TDS Return Filing Due Date, so that they can fulfill your TDS obligations efficiently. Taxpayers can avoid penalties by sticking to the deadlines and by accurate filing of TDS. Timely filing of TDS will make sure about the availability of tax credits. You can also seek the professional guidance of experts like Legal Pillers for timely filing of the TDS Return.
RMD24 | Debunking the non-endemic revenue myth Marvin Vacquier Droop | First ...BBPMedia1
Marvin neemt je in deze presentatie mee in de voordelen van non-endemic advertising op retail media netwerken. Hij brengt ook de uitdagingen in beeld die de markt op dit moment heeft op het gebied van retail media voor niet-leveranciers.
Retail media wordt gezien als het nieuwe advertising-medium en ook mediabureaus richten massaal retail media-afdelingen op. Merken die niet in de betreffende winkel liggen staan ook nog niet in de rij om op de retail media netwerken te adverteren. Marvin belicht de uitdagingen die er zijn om echt aansluiting te vinden op die markt van non-endemic advertising.
Enterprise Excellence is Inclusive Excellence.pdfKaiNexus
Enterprise excellence and inclusive excellence are closely linked, and real-world challenges have shown that both are essential to the success of any organization. To achieve enterprise excellence, organizations must focus on improving their operations and processes while creating an inclusive environment that engages everyone. In this interactive session, the facilitator will highlight commonly established business practices and how they limit our ability to engage everyone every day. More importantly, though, participants will likely gain increased awareness of what we can do differently to maximize enterprise excellence through deliberate inclusion.
What is Enterprise Excellence?
Enterprise Excellence is a holistic approach that's aimed at achieving world-class performance across all aspects of the organization.
What might I learn?
A way to engage all in creating Inclusive Excellence. Lessons from the US military and their parallels to the story of Harry Potter. How belt systems and CI teams can destroy inclusive practices. How leadership language invites people to the party. There are three things leaders can do to engage everyone every day: maximizing psychological safety to create environments where folks learn, contribute, and challenge the status quo.
Who might benefit? Anyone and everyone leading folks from the shop floor to top floor.
Dr. William Harvey is a seasoned Operations Leader with extensive experience in chemical processing, manufacturing, and operations management. At Michelman, he currently oversees multiple sites, leading teams in strategic planning and coaching/practicing continuous improvement. William is set to start his eighth year of teaching at the University of Cincinnati where he teaches marketing, finance, and management. William holds various certifications in change management, quality, leadership, operational excellence, team building, and DiSC, among others.
Discover the innovative and creative projects that highlight my journey throu...dylandmeas
Discover the innovative and creative projects that highlight my journey through Full Sail University. Below, you’ll find a collection of my work showcasing my skills and expertise in digital marketing, event planning, and media production.
Falcon stands out as a top-tier P2P Invoice Discounting platform in India, bridging esteemed blue-chip companies and eager investors. Our goal is to transform the investment landscape in India by establishing a comprehensive destination for borrowers and investors with diverse profiles and needs, all while minimizing risk. What sets Falcon apart is the elimination of intermediaries such as commercial banks and depository institutions, allowing investors to enjoy higher yields.
VAT Registration Outlined In UAE: Benefits and Requirementsuae taxgpt
Vat Registration is a legal obligation for businesses meeting the threshold requirement, helping companies avoid fines and ramifications. Contact now!
https://viralsocialtrends.com/vat-registration-outlined-in-uae/
Digital Transformation and IT Strategy Toolkit and TemplatesAurelien Domont, MBA
This Digital Transformation and IT Strategy Toolkit was created by ex-McKinsey, Deloitte and BCG Management Consultants, after more than 5,000 hours of work. It is considered the world's best & most comprehensive Digital Transformation and IT Strategy Toolkit. It includes all the Frameworks, Best Practices & Templates required to successfully undertake the Digital Transformation of your organization and define a robust IT Strategy.
Editable Toolkit to help you reuse our content: 700 Powerpoint slides | 35 Excel sheets | 84 minutes of Video training
This PowerPoint presentation is only a small preview of our Toolkits. For more details, visit www.domontconsulting.com
RMD24 | Retail media: hoe zet je dit in als je geen AH of Unilever bent? Heid...BBPMedia1
Grote partijen zijn al een tijdje onderweg met retail media. Ondertussen worden in dit domein ook de kansen zichtbaar voor andere spelers in de markt. Maar met die kansen ontstaan ook vragen: Zelf retail media worden of erop adverteren? In welke fase van de funnel past het en hoe integreer je het in een mediaplan? Wat is nu precies het verschil met marketplaces en Programmatic ads? In dit half uur beslechten we de dilemma's en krijg je antwoorden op wanneer het voor jou tijd is om de volgende stap te zetten.
Cracking the Workplace Discipline Code Main.pptxWorkforce Group
Cultivating and maintaining discipline within teams is a critical differentiator for successful organisations.
Forward-thinking leaders and business managers understand the impact that discipline has on organisational success. A disciplined workforce operates with clarity, focus, and a shared understanding of expectations, ultimately driving better results, optimising productivity, and facilitating seamless collaboration.
Although discipline is not a one-size-fits-all approach, it can help create a work environment that encourages personal growth and accountability rather than solely relying on punitive measures.
In this deck, you will learn the significance of workplace discipline for organisational success. You’ll also learn
• Four (4) workplace discipline methods you should consider
• The best and most practical approach to implementing workplace discipline.
• Three (3) key tips to maintain a disciplined workplace.
Intertek your guide-to_brazil_market_access your guide to brazilian
1. Your Guide to Brazilian
Market Access
Intertek
Cleeve Road, Leatherhead, Surrey KT22 7SB UK
info.uk@intertek.com 01372 370900 www.intertek.com
2. Your Guide to Brazilian
Market Access
Robust growth offer opportunities for increased sales
Although annual GDP growth in Brazil has averaged only three to four percent,
this slower pace of growth reflects Brazil’s increased economic stability, which has
resulted in job growth and higher wages for Brazil’s population of over 195 million.
With a population of more than 195 million people and a mature healthcare
system, Brazil represents the largest medical equipment market in South America
and one of the largest markets in the world. Manufacturers seeking to expand
their market reach by selling medical devices in Brazil will encounter an evolving
regulatory approvals system, including mandatory device registration. Because the
Brazilian market represents such a great opportunity, manufacturers of medical
devices can manufacture from understanding both the regulatory requirements
and the registration and certification process for their products.
Why Stop at Brazil?
In addition to the current size and projected
growth of the Brazilian appliances and consumer
electronics market, there are also many
opportunities available through Mercosur
(Southern Common Market), an economic and
political agreement between Argentina, Brazil,
Paraguay and Uruguay which supports free trade.
This union, similar to the North American Free
Trade Agreement (NAFTA), greatly simplifies
exporters’ ability to expand into all four markets.
This agreement allows manufacturers who certify
their products’ compliance with Brazilian
requirements to expand their foothold quickly. It
also allows manufacturers to leverage their brand
awareness, already garnered in the Brazilian
market, across several other countries.
This union continues to expand to include more Latin American countries, allowing
importers to reap sizeable benefits through interactions within this growing
trading zone.
www.intertek.com 1
3. Your Guide to Brazilian
Market Access
Principal Regulatory and Accreditations Bodies.
INMETRO, the National Institute of Methodology, Standardization and Industrial
Quality, is the accreditation body of conformity assessment approved by the
Brazilian Government. Residential appliances and Consumer Electronic products
entering the Brazilian market must obtain certification by an INMETRO accredited
laboratory and carry the Mark of that lab along with the mandatory INMETRO
mark.
ANVISA (National Sanitary Agency), they is a Brazilian Government Agency that is
responsible to define the regulation of health products (like Medical Devices and
Drugs). They define the criterions of certification and register this type of products.
ANATEL (National Telecommunications Agency), it is a Brazilian Government
Agency that is responsible to define the regulation of telecommunications
products and services. Manufacturers of Telecommunications Equipment located in
Brazil or who export to Brazil should verify if their products require mandatory
certification. ANATEL provides the specific criteria, rules and standards.
Certification schemes
Mandatory certifications
The mandatory certification is required by law or regulation and gives priority to
issues of safety and environment, so the products listed in the regulations may be
marketed only after their certification. There are 110 different types of products
under the mandatory program. See the website:
http://www.inmetro.gov.br/qualidade/prodCompulsorios.asp
Below are the main products under mandatory certification:
• Hazardous locations equipment
• Medical devices (Electrical medical products)
• Wire and cable
• Household Appliances
• Switches, plugs and receptacles
www.intertek.com 2
4. Your Guide to Brazilian
Market Access
Voluntary certifications
Voluntary certification, although not a mandatory requirement for conformity
assessment of products and services ensures a competitive advantage, besides
proving that follow a standard and that have been evaluated in several items of
safety and performance. There are 10 different programs under voluntary scheme
where the license holder can use the Inmetro Mark, for example: Information
Technology products or information technology goods, under a special ordinance
(Nbr 170).
Brazilian Labelling Program
Energy Efficiency
In regards to Energy Efficiency
requirements, concerning energy
consumption for example, a
manufacturer may choose to apply for
the voluntary PROCEL program.
PROCEL was developed and provided
by the National Electricity
Conservation and is coordinated by
the Ministry of Mines and Energy
(MME) in conjunction with the
Brazilian Electric Power Company,
Eletrobrás. PROCEL aims to guide
consumers via a label indicating levels
of greater energy efficiency within
various categories (see the list of products under PBE – Brazilian Labelling Program
below), thus providing electricity bill savings. In the process of granting PROCEL,
Eletrobrás has a partnership with INMETRO.
See the web-site: http://www.inmetro.gov.br/qualidade/eficiencia.asp
Important Note: The manufacturer has to apply for testing in one of the INMETROs accredited or designated labs (In Brazil
only) and then to apply to INMETRO the authorization to apply the efficiency label on the product. Foreign companies are
required to have a representative (a legal representative established in Brazil) in Brazil who should apply directly to INMETRO
www.intertek.com 3
5. Your Guide to Brazilian
Market Access
Program/Product Methodology Character
Electrical appliances for heating water (showers, taps and heaters type
passage and accumulation)
Declaration Mandatory
Gas water heaters, instant and accumulation types Declaration Mandatory
Centrifuge pumps Declaration Mandatory
Air Conditioners Declaration Mandatory
Commercial and public service buildings, Inspection Voluntary
Residential buildings Inspection Voluntary
Solar Water Heating Equipment (Reservoirs thermal solar collectors for
pool and bath application systems coupled)
Declaration
Voluntary
Gas Stoves and Ovens Declaration Mandatory
Microwave Ovens Certification Mandatory
Commercial electric ovens Certification Mandatory
Incandescent lamp of domestic use Declaration Mandatory
Incandescent lamp of decorative use Declaration Voluntary
Compact fluorescent lamps with integrated reactor-based Declaration Mandatory
Sodium Vapor Lamps to high pressure Declaration Mandatory
Electromagnetic ballasts for high pressure vapor sodium lamps and
Metal vapor (Halides)
Certification Mandatory
Washing machines Declaration Mandatory
Electric motors three phase induction squirrel cage rotor - High
yield
Declaration
Mandatory
refrigerators, freezers and their counterparts household Declaration Mandatory
Systems and equipment for photovoltaic energy (modules,
inverters, controllers and batteries)
Declaration
Mandatory
Televisions Declaration Mandatory
distribution Transformers with Liquid Insulator Declaration Voluntary
passenger vehicles and commercial vehicles Declaration Voluntary
Table, Column and Air Circulators Fans Certification Mandatory
Ceiling Fans Declaration Mandatory
Note: Declaration must be conducted by the in country Supplier or Vendor
Seal Noise
A common example of mandatory compliance regards
noise generation. If your product is a hair dryer, a
vacuum cleaner or a blender, it is mandatory to label
your product with its sound level. INMETRO and IBAMA
(Brazilian Institute of Environment and Renewable
Natural Resources) created the Seal Noise, part of the
Silence Program, which aims to combat noise pollution
by guiding the consumer to purchase quieter
appliances and encouraging manufacturers to produce
products with increasingly lower noise levels.
In addition to the performance aspects of a product, safety must also be
considered. Important regulation changes for the appliance and electronics
markets.
Note: Governmental agencies can change or modify regulations at any time. Please contact your Intertek representative for
the most up to date information relative to your specific product opportunity
www.intertek.com 4
6. Your Guide to Brazilian
Market Access
Getting Ready for Certification and Ordinances
How can manufacturers of household appliances, Medical Products and Consumer
Electronic products actually leverage Brazil’s growing market? As with many
countries, regulations are constantly evolving for products that will be sold in this
market. To stay compliant with these regulations, a manufacturer needs to partner
with an expert certification and testing laboratory that is ready to help today. This
partnership will be especially beneficial to manufacturers while navigating the
certification process and when getting ready to ship to a foreign country.
Requirements: Where to Start?
First of all, it is important to understand the requirements, named ”RAC” -
Requirements for Conformity Assessment or Ordinances that apply to your product.
Learn to differentiate between mandatory versus voluntary, and safety versus
performance related regulations.
Steps of the Conformity Assessment that should include, at least, the following
items:
• Definition of the Certification Model(s) used: type 1 - 9 or by batch;
• Initial Assessment;
• Certification Request;
• Analysis of Documentation Conformity and Request;
• Initial Audit of the Administration System(s) (when applicable): Most of
programs require items according to NBR ISO 9001. NBR ISO 13.485 have
to be used for Medical Devices;
• Initial Essay Plan;
• Handling of non-conformities in the Initial Assessment step;
• Issue of Certificate;
• Maintenance Assessment;
• Maintenance Audit (when applicable): once an year;
• Maintenance Essays Plan;
• Handling of non-conformities in the Maintenance step;
• Maintenance Confirmation;
www.intertek.com 5
7. Your Guide to Brazilian
Market Access
• Recertification Evaluation;
• Handling of non-conformities in the Recertification step;
• Recertification Confirmation; VII – Handling of Claims.
Household Appliances
Household appliance and consumer electronics markets are largely due to growing
consumer confidence, consistently low unemployment rates and increased
disposable income, especially among lower-income consumer groups. Major
appliances had record retail sales growth in 2011 while small appliances also
performed well, specifically in the personal care appliances, small cooking
appliances and vacuum cleaners sector.
Ordinance 371
On 29 December 2009, INMETRO, the Brazilian quality, standards and metrology
bureau, issued Ordinance 371 stipulating that any electrical household appliances
made in or imported to Brazil needs to pass mandatory product certification before
being sold on the Brazilian market. The Ordinance’s implementation was divided
into three stages spanning over 2011, 2012 and 2013. On August 8, 2011,
INMETRO issued Ordinance 328 as an amendment to explain, clarify and
supplement parts of Ordinance 371.
In the first stage, since July 1, 2012, manufacturers or importers of electrical
household appliances have been forbidden to import products without mandatory
certification.
The second stage, which began on July 1, 2013, forbids manufacturers and
importers to sell products to wholesalers and retailers without the mandatory
certifications.
In the third stage, now due to commence on January 1, 2014, wholesalers and
retailers of electrical household appliances will be forbidden from selling products
without the mandatory certifications.
These dates are in fact a year later than originally planned, in order to include a
series of products mentioned in Ordinance 328/2011, which supplements the
product range stipulated in ordinance 371/2009. These products are: compressors,
electrical stoves, electrical ovens (except those covered by IEC 60335-2-36 and IEC
60335- 2-42), commercial microwave ovens covered by IEC60335-2-90, jacuzzis,
dryers, dishwashers, wine fridges, freezers, commercial refrigerators, hybrid
accumulation water heaters and heat pumps.
www.intertek.com 6
8. Your Guide to Brazilian
Market Access
Products Covered by Ordinance 371:
Ordinance 371 applies to most electrical household appliances included in ABNT,
NBR, NM, NM National Standards or IEC 60335-2-X, except Products included in
other clauses of INMETRO:
• Water dispensers (Ordinance 191)
• Gas furnaces (Ordinance 18)
• Electric heat showers (Ordinance 211)
• Refrigerator and freezers (Ordinance 20)
• Air conditioners (Ordinance 14)
• Washing machines (Ordinance 185)
Products excluded in Ordinance 328:
• Centrifuge covered by IEC 60335- 2-4
• Microwave ovens covered by IEC 60335-2-25
• Commercial electric ovens covered by IEC 60335-2- 36 and IEC 60335-2-42
• Water pumps covered by IEC 60335-2- 41
• Motor-driven pumps in IEC 60335-2-51(stationary circulation pumps for
heating and service water installations)
• UV and IR radio skin exposing devices covered by IEC 60335-2-27
• Massagers covered by IEC 60335-2-32
• Projectors and similar equipment covered by IEC 60335-2-56
Main requirements of Ordinance 371:
Testing requirements: Ordinance 371 only sets requirements for safety tests,
without requirements for EMC or energy efficiency testing. According to the
Ordinance, all products covered should be in compliance with IEC 60335-1 and
IEC 60335-2-X, as well as any Brazilian national deviations. But, at present, only
electric irons covered by IEC 60335-2-3 are required to comply with the following
deviation: Power cords of electric irons should be in compliance with Ordinance
286.
www.intertek.com 7
9. Your Guide to Brazilian
Market Access
IMPORTANT: Electric plugs or sockets incorporated in household appliances exported to Brazil should acquire INMETRO
NBR14136 (see details about the Brazilian Plug requirements below).
Test Report Requirements: To apply for the INMETRO mandatory product
certification, test reports issued by ILAC labs (International Laboratory
Accreditation Cooperation) can be accepted.
Importer Requirements: The Ordinance also stipulates that importers who apply
for the mandatory INMETRO Mark shall establish a Customer Service Centre to
provide the relevant support to Brazilian consumers.
Exporter / Factory Requirements: Ordinance 371 stipulates that regular
assessments of manufacturers shall be conducted to ensure their compliance with
the requirements.
As for domestic exporters of electric household appliances, because most
requirements in Ordinance 371 are similar to those of CE and GS in the European
Union, they can use the certification for export to Brazil if they update the product
design and make timely preparations for certification.
Medical Devices, Electrical Medical Products
These Requirements for Conformity Assessment (RAC) establish the criteria for
Electrical Equipment under Health Surveillance, meeting the requirements of the
standards listed in Additional Documents, seeking the safety of the user.
Brazil’s current regulatory framework for medical devices, and the requirements
for those entities seeking to manufacture, import or sell medical devices in the
country. It also discusses the registration and certification process required of all
device manufacturers, importers and distributors, and the steps necessary to
secure and maintain approval for medical devices. This white paper includes
information on requirements found in RDC 27/IN-3 and Ordinance 350, published
by Brazilian regulatory authorities in June 2011.
Regulatory Background:
Resolution RDC No. 185 of October 22, 2001 is the primary regulation applicable
to the registration of all medical devices, except for in vitro diagnostic (IVD) devices,
which are covered by Resolution RDC No. 206 of November 2006. RDC No. 185
describes the applicable device registration protocol and lists the documents
required to legally register a medical device in Brazil. Annex II of RDC No. 185
describes the classification structure applicable to medical devices, assigning
medical devices to one of four distinct risk classes (I, II, III and IV) according to 18
different rules.
www.intertek.com 8
10. Your Guide to Brazilian
Market Access
The classification structure for medical devices in Brazil corresponds to that used in
the European Union (EU) under Council Directive 93/42/EEC concerning medical
devices.
ANVISA Registration Process:
All medical devices imported into or distributed within Brazil must first be
registered with the ANVISA “National Health Surveillance Agency”, responsible for
the regulation and oversight of medical devices and other medical products in
Brazil. Specifically, ANVISA is responsible for the registration of medical devices
and for the maintenance of a registered products database. Unlike the EU Notified
Body system, the 510(k) system of the Food and Drug Administration (FDA) in the
United States, or the Canadian Medical Device Conformity Assessment System
(CMDCAS), ANVISA performs all registration and inspection functions within the
agency.
Only companies based in Brazil can apply for ANVISA registration. Therefore,
companies based elsewhere that do not have subsidiaries in Brazil must depend on
Brazilian-based third parties, such as hosting companies, distributors and dealers,
to obtain ANVISA registration for medical devices. Under such an arrangement,
the local third party holds the ANVISA registration, and a manufacturer must
maintain an effective commercial relationship with a third party to ensure the on-
going maintenance of a registration. Otherwise, a manufacturer will need to
repeat the registration process with another local third party to maintain market
access.
The registration of most Class 1 and 2 devices involves a relatively simple
application process – referred to as “cadastro,” meaning “abbreviated
registration” – based on the low to moderate risk associated with devices in these
classes.
However, based on the greater degree of risk associated with their use, a more
rigorous process applies to some Class 1 and Class 2 medical devices, as well as all
Class 3 and Class 4 devices. In these cases, the party applying for ANVISA
registration may be required to provide some or all of the following
documentation with an application, depending on the device characteristics and
classification:
1. Free sales certificate (it can be replaced by the INMETRO certificate when
applicable);
2. Certificate of Good Manufacturing Practice (GMP);
3. Instructions manual in Portuguese;
4. Labelling and packaging;
www.intertek.com 9
11. Your Guide to Brazilian
Market Access
5. Letter from the device manufacturer, authorising a Brazilian company to hold
the product registration and distribute a device;
6. Clinical trials (sometimes it can be replaced by the INMETRO certification or
literature proving the effectiveness of the device);
7. List of all device accessories;
8. For some devices, such as implantable medical devices, cardiovascular products,
high-risk IVDs, dialysis equipment and personal hearing aid systems, an Economic
Information Report;
9. INMETRO certificate, when applicable the complete set of documentation
depends on the nature of the device, e.g., IVD devices, implants, electro-medical
devices, etc. Defining the exact package of documentation is a complex process,
and requires consulting various laws and decrees (Law 6360:1976, RDC No.
185:2001 and RDC No. 59:2000). The documentation list above applies to the
majority of medical devices; in practice, however, required documentation can be
much more extensive.
GMP Inspection and Certification GMP certification based on an inspection
conducted by ANVISA is required for registration (RDC No. 25, May 21, 2009). The
GMP certificate must be submitted with the registration application for all Class III
and IV devices, as well as for Class I and II devices noted on the Exemption List
(Instruction IN-2, June 6, 2011). GMP inspections are also required to revalidate or
update existing registrations. The GMP certificate is valid for two years, and
ANVISA alone determines whether subsequent evaluations can be completed
remotely through a paperwork audit. The application for GMP should contain the
following documentation:
• Device description and indication of risk class;
• Complete flow chart describing the relationship with third-party
manufacturers, if any;
• Payment receipt for the GMP inspection fee;
• The GMP inspection check for compliance with RDC No. 59.
www.intertek.com 10
12. Your Guide to Brazilian
Market Access
To qualify for INMETRO certification, medical device manufacturers must have their
products tested to SBAC-recognized standards by an INMETRO accredited testing
laboratory. Consistent with the requirements of RDC No. 27 and IN-3 published in
June 2011, all medical devices sold in Brazil that fall under the scope of the
following standards must be INMETRO certified:
• NBR IEC 60601 series;
• NBR ISO 6875:1998:Dental patient chair;
• NBR ISO 7785-1:1999: Dental handpieces – Part 1: High-speed air turbine
handpieces;
• NBR ISO 7785-2:2004: Dental handpieces – Part 2: Straight and geared
angle handpieces;
• NBR ISO 9680:2001: Dentistry - Operating lights;
• NBR ISO 9919:1997: Medical electrical equipment – Particular requirements
for the basic safety and essential performance of pulse oximeter equipment
for medical use;
• NBR ISO 11195:2000: Gas mixers for medical use – Stand-alone gas mixers;
• NBR ISO 8835-2:2010: Inhalational anaesthesia systems – Part 2:
Anaesthetic breathing systems;
• NBR IEC 61689:1998: Ultrasonics – Physiotherapy systems – Field
specifications and methods of measurement in the frequency range 0.5
MHz to 5 MHz
www.intertek.com 11
13. Your Guide to Brazilian
Market Access
About 3rd edition of IEC 60601-1
Under RDC No. 27 and Instruction IN-3, the 3rd edition of the IEC 60601-1 is now
acceptable in Brazil for INMETRO certification. This is a significant change from
RCD No. 32 which omitted the 3rd edition of IEC 60601-1 from the Brazilian
certification scheme. But it will only be required (compulsory) from Jan/1st/2014.
Technical requirements for the evaluation of the quality system By ABNT NBR ISO
13485:2004
In the initial and maintenance evaluation of the SGQ (QMS) of the manufacturer
using the ABNT NBR 13485:2004 for the products object of certification, must
verify compliance with the requirements listed below:
• Control of documents
• Control of records
• Planning of product realization
• Customer communication (ref. handling customer complaints 7.2.3.c)
• Design and development validation
• Control of design and development changes
• Verification of purchased product
• Control of production and service provision
• Validation of processes for production and service provision
• Identification and traceability
• Preservation of product
• Control of monitoring and measuring devices
• Monitoring and measurement of processes
• Monitoring and measurement of product
• Control of non-conforming product
• Corrective action
www.intertek.com 12
14. Your Guide to Brazilian
Market Access
New requirements for syringes, needles and infusion sets
Since June 2013 additional devices falling under the general categories of syringes,
needles and infusion sets have needed to comply with a requirement for INMETRO
certification. In addition to the initial factory inspection, these devices will need to
undergo batch testing to NBR and ISO standards at an ILAC accredited laboratory.
These test reports are then analysed by experts and if they pass, then, will issue the
INMETRO certificate.
Laboratory Definition
The accredited Certification Body (CB) can use any laboratory accredited within the
ILAC MLA, but the laboratory must have the correct standard in their scope by of
the essays specified in the RAC or Ordinance.
In case of non-accredited laboratories, the CB should register, through
corroborative documents, the reasons that resulted in selection of the laboratory,
recording also the results of the evaluations carried out for its qualification effect.
For definition of the laboratories, the following items should be considered:
a) The laboratories defined should be of third parties and duly accredited by
Cgcre/INMETRO;
b) Exceptionally, and as long as conditioned to evaluation and approval of CB, a
non-accredited laboratory can be used for the specific scope, when one of the
hypothesis configured below occurs:
i) When no accredited laboratory exist for the specific scope related to the
RAC/ordinance;
ii) When only one accredited laboratory exists and the CB evidences that
the price for analyses of the non-accredited laboratory plus the costs
resulting from CB evaluation, in comparison with the accredited laboratory
is, at least 50% lower;
iii) When the accredited laboratory(ies) within a maximum period of two
months, cannot start the analyses or the essays foreseen in the Conformity
Assessment Requirements - RAC;
www.intertek.com 13
15. Your Guide to Brazilian
Market Access
c) When no third party accredited laboratories exist for the scope, the CB should
follow the priority order mentioned below in selection of the laboratory:
• First party accredited laboratory
• Third party laboratory accredited for other scope of essays
• First party laboratory accredited for other scope of essays
• Third party non accredited laboratory
• First party non accredited laboratory
d) When INMETRO defines a non-accredited laboratory, such laboratory will have a
period of time of 18 months to obtain its accreditation, without such accreditation
the laboratory shall not participate in the conformity assessment program under
discussion;
e) The assessment executed by the CB in the non-accredited laboratory should be
executed by an CB professional having a training register, of at least 16
hours/lesson, under the ABNT NBR ISO IEC 17025 Rule in force, in addition of
formal evidence of experience and specific technical knowledge, as related to the
essays to be evaluated;
f) If 1st party laboratory is contracted, the CB should accompany execution of all
the essays, every time that the laboratory executes this service;
g) If a non-accredited laboratory or accredited laboratories of the 1st or 3rd party
are contracted for other scope of essay, CB should evaluate the requirements
indicated in Attachment A of the present document;
h) For the essays carried out by foreign laboratories, as long as agreed upon by the
regulator, the equivalence of the essay method and the sampling methodology
established should be considered and documented. In addition, these laboratories
should be accredited by Inmetro or by an OAC that is a signatory of a mutual
acknowledgement agreement of which Inmetro is also a participant. These are:
- Interamerican Accreditation Cooperation – IAAC;
- International Laboratory Accreditation Cooperation – ILAC;
www.intertek.com 14
16. Your Guide to Brazilian
Market Access
What About EMC?
Now, let’s assume that with all of its products, your company always carries out
complete EMC (electromagnetic compatibility) testing for the US and EU. Is that
enough to allow you to place products everywhere in the world? Unfortunately,
this is not the case. Many countries that require EMC compliance also impose
additional requirements to market entry in terms of deviations to international
standards, in-country testing or country presence.
In Brazil, INMETRO is again the authority with jurisdiction over the general safety
of products as well as EMC. However, there are some general products that
require safety for INMETRO certification and none that require EMC at this time.
Only two programs include EMC tests in their programs:
• Medical Devices : Ordinance 350 (Compulsory)
• IT Products or information technology goods: Ordinance 170 (Voluntary)
Test Reports Acceptance
Laboratory: As described above only test reports issued by an accredited lab can
be accepted (see item 7.1): By Inmetro or ILAC or IAAC member
Validity: It is very important to check what the Ordinance is declaring as validity of
the test reports to be used in the certification process. Examples - Medical Devices:
reports with only two years of validity
Brazilian Standard of Plugs and Sockets
Standard
Voltage: 127
and 220 Volts /
60 Hz
www.intertek.com 15
17. Your Guide to Brazilian
Market Access
How can Intertek help?
Intertek is now accredited by INMETRO as Product Certification Body – OCP for the
following product categories:
• Med (IEC 60601 series)
• Household (IEC 60335 series)
• OFF / IT products (IEC 60950)
We are well-versed in the new regulations that affect all types of electrical product
and can help get your product ready for Brazil. We provide:
• On-site Audit with local auditors.
• Testing to help you obtain the INMETRO Mark.
• Inspection: Intertek local auditors provide both pre-license and follow-up
inspection, to ensure on-going compliance.
• Certification, such as INMETRO, as well as additional in country
performance evaluations.
• Maintenance of Certificate: Intertek will verify that your product continues
to comply as well as provide the Issuance of the Certificate of
Compliance maintenance when is applicable.
• Fast project pick up and turn around, for faster market access
Summary
Intertek’s product testing and certification specialists will provide the knowledge
and guidance you need to focus on the details – numbers, timing, process – to
certify your home appliances, consumer electronics and medical devices for use in
the Brazilian market. Our partnerships in Brazil allow us to accelerate not only the
test reports, but the entire certification process, saving you both time and money.
For example, with Intertek’s local auditors, you won’t need to fly an auditor from
Brazil (and spend the time and money to get his visa!) just because you
manufacture your product in another country!
Please contact us on +44(0) 1372370900 or email us at info.uk@intertek.com, for
more information on our Brazilian compliance services or to request a quotation.
For more information on specific testing and certification information, please
visit our website at www.intertek.com.
This publication is copyright Intertek and may not be reproduced or transmitted in any form in whole or in part without the
prior written permission of Intertek. While due care has been taken during the preparation of this document, Intertek
cannot be held responsible for the accuracy of the information herein or for any consequence arising from it. Clients are
encouraged to seek Intertek’s current advice on their specific needs before acting upon any of the content.
www.intertek.com 16