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Brazil  and more
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
Latin America GDP Brazil $2,181,677
Why Brazil?!
Business Opportunity  Medical Devices  Brazil ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Business Opportunity  Medical Devices  Brazil Huge 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.
The challenges - Brazil ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
The challenges - Brazil ,[object Object],[object Object],[object Object],[object Object],[object Object]
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.
Regulatory Alternatives Company Incorporation Brazil Assemble local GMP in Brazil   Register   ANVISA submit paperwork for ANVISA   24-36 Months 24  Months 6-8 Months Mfg. local GMP in Israel   Inspection  GMP   and INMETRO if needed
The solutions ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Why us? Quality We make it better Partnership We make it together Accessibility We make it accessible Efficiency We make it happen
Why us? ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Why us? ,[object Object],[object Object],[object Object],[object Object],[object Object]
 
 
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 .
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.

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Medical Device - ANVISA regulation in Brazil

  • 1. Brazil and more
  • 2. 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
  • 3. Latin America GDP Brazil $2,181,677
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  • 8. 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.
  • 9. Regulatory Alternatives Company Incorporation Brazil Assemble local GMP in Brazil Register ANVISA submit paperwork for ANVISA 24-36 Months 24 Months 6-8 Months Mfg. local GMP in Israel Inspection GMP and INMETRO if needed
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  • 11. Why us? Quality We make it better Partnership We make it together Accessibility We make it accessible Efficiency We make it happen
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  • 16. 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 .
  • 17. 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.