medical device - anvisa regulation in brazil

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Brazil and more

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Brazil International Ltd. is a boutique company that provides business services for companies in the medical device field, seeking to successfully penetrate and participate in the Brazilian market.

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Page 1: Medical Device - ANVISA regulation in Brazil

Brazil and more

Page 2: Medical Device - ANVISA regulation in Brazil

Latin America

Total population : 590,086,590

Pop. Density : 27 per sq/km

Total countries : 20

Dependencies : 10

Language : Spanish, Portuguese

Time zone : UTC -2 to UTC -8

Page 3: Medical Device - ANVISA regulation in Brazil

Latin America GDP

Brazil $2,181,677

Page 4: Medical Device - ANVISA regulation in Brazil

Why Brazil?!

Page 5: Medical Device - ANVISA regulation in Brazil

Business Opportunity Medical Devices

BrazilHuge consumer market of about 200 million people.

Advanced private medical system.

About 3,500 private medical institutions.

Increased awareness for advanced technology solutions.

Available tenders at all governmental levels.

Focal point and access to the rest of Latin America and more.

Business Opportunity Medical Devices

BrazilHuge consumer market of about 200 million people.

Advanced private medical system.

About 3,500 private medical institutions.

Increased awareness for advanced technology solutions.

Available tenders at all governmental levels.

Focal point and access to the rest of Latin America and more.

Page 6: Medical Device - ANVISA regulation in Brazil

The challenges - BrazilVery strict regulation in all aspects: Commercial,

Taxation and Legal with numerous authorities.

Business activity is only possible for local regulated

companies.

Establishment of a local company involves expensive

regulation and time consuming.

Marketing infrastructure: strategic business partners.

Page 7: Medical Device - ANVISA regulation in Brazil

The challenges - Brazil

Culture and language barrier.

Different time zone and geographical distance.

Management of control and monitoring.

Time to market. Local infrastructure is required in all aspects.

Page 8: Medical Device - ANVISA regulation in Brazil

ANVISA Was established in January 26th 1999 with the purpose to foster protection

the health of the population by regulating, controlling and inspecting products

and services in the medical device field, drugs, cosmetics, food and tobacco.

Sanitary control over production and marketing of products and services subject to

sanitary surveillance.

To authorize the operation of manufacturing, distribution and importing firms.

To grant and to withdraw certificates of good manufacturing practice; GMP.

Page 9: Medical Device - ANVISA regulation in Brazil

Regulatory AlternativesCompany

IncorporationBrazil

Assemble localGMP inBrazil

Register ANVISA

submit paperwork for

ANVISA

24-36Months

24 Months

6-8Months

Mfg. local GMP in Israel

Inspection GMP

and INMETROif needed

Page 10: Medical Device - ANVISA regulation in Brazil

The solutionsOne stop shop - Handle all aspects of regulatory, legal, commercial/marketing, taxation.

An Israeli company is your legal representative in Brazil for all commercial aspects.

Relatively small initial costs as an alternative of establishing a company in Brazil.

T2M – Finding Distributors & End customers.

Doing business in your language at the comfort of your office, in your local timezone.

Providing creative solutions to complex challenges, based on customer requirements.

Tailor made solutions for YOU.

Page 11: Medical Device - ANVISA regulation in Brazil

Why us?

QualityWe make it better

PartnershipWe make it together

AccessibilityWe make it accessible

EfficiencyWe make it happen

Page 12: Medical Device - ANVISA regulation in Brazil

Why us?An Israeli company as your strategic partner in Brazil.

Our leading team members have the knowledge and a vast experience in

marketing, regulatory process and the laws in the local market.

Providing creative solutions to regulatory challenges at the entrance to the

Brazilian market.

Support, accompaniment, monitoring and guidance, from initial meeting

through establishing the local operations and implementation of business

activity in Brazil.

Commercial consulting prior to entering the Brazilian market.

Page 13: Medical Device - ANVISA regulation in Brazil

Why us?Legal consulting in the Brazilian market.

Established network of Distributors and end customers.

Signing a contract with us as an Israeli company, gives you leverage in your

legal rights compared with the local product holder, according to the

Brazilian laws.

Access to tenders at all governmental levels with vast experience at the

Medical Device field.

Sales hub to south America and Arab countries who won't buy Israeli

manufactured products.

Page 14: Medical Device - ANVISA regulation in Brazil
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Our state of the art site in Ribeirão Preto, Brazil, built with the highest standards of ANVISA and includes

sterile rooms, assembly line, warehouse and offices.

Page 17: Medical Device - ANVISA regulation in Brazil

Your Private Office in South America

An option of establishing a marketing and distribution local center, including

the employment of a regional sales manager at customer’s direct management

and supervision, as part of our infrastructure in Brazil.

Reducing marketing expenses.

Local business culture.

Real-time marketing.