Medical Device - ANVISA regulation in Brazil


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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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Medical Device - ANVISA regulation in Brazil

  1. 1. Brazil and more
  2. 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. 3. Latin America GDP Brazil $2,181,677
  4. 4. Why Brazil?!
  5. 5. Business Opportunity Medical Devices Brazil <ul><li>Huge consumer market of about 200 million people. </li></ul><ul><li>Advanced private medical system. </li></ul><ul><li>About 3,500 private medical institutions. </li></ul><ul><li>Increased awareness for advanced technology solutions. </li></ul><ul><li>Available tenders at all governmental levels. </li></ul><ul><li>Focal point and access to the rest of Latin America and more. </li></ul>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.
  6. 6. The challenges - Brazil <ul><li>Very strict regulation in all aspects: Commercial, </li></ul><ul><li>Taxation and Legal with numerous authorities. </li></ul><ul><li>Business activity is only possible for local regulated </li></ul><ul><li>companies. </li></ul><ul><li>Establishment of a local company involves expensive </li></ul><ul><li>regulation and time consuming. </li></ul><ul><li>Marketing infrastructure: strategic business partners. </li></ul>
  7. 7. The challenges - Brazil <ul><li>Culture and language barrier. </li></ul><ul><li>Different time zone and geographical distance. </li></ul><ul><li>Management of control and monitoring. </li></ul><ul><li>Time to market. </li></ul><ul><li>Local infrastructure is required in all aspects. </li></ul>
  8. 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. 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
  10. 10. The solutions <ul><li>One stop shop - Handle all aspects of regulatory, legal, commercial/marketing, </li></ul><ul><li>taxation. </li></ul><ul><li>An Israeli company is your legal representative in Brazil for all commercial </li></ul><ul><li>aspects. </li></ul><ul><li>Relatively small initial costs as an alternative of establishing a company in Brazil. </li></ul><ul><li>T2M – Finding Distributors & End customers. </li></ul><ul><li>Doing business in your language at the comfort of your office, in your local time </li></ul><ul><li>zone. </li></ul><ul><li>Providing creative solutions to complex challenges, based on customer </li></ul><ul><li>requirements. </li></ul><ul><li>Tailor made solutions for YOU. </li></ul>
  11. 11. Why us? Quality We make it better Partnership We make it together Accessibility We make it accessible Efficiency We make it happen
  12. 12. Why us? <ul><li>An Israeli company as your strategic partner in Brazil. </li></ul><ul><li>Our leading team members have the knowledge and a vast experience in </li></ul><ul><li>marketing, regulatory process and the laws in the local market. </li></ul><ul><li>Providing creative solutions to regulatory challenges at the entrance to the </li></ul><ul><li>Brazilian market. </li></ul><ul><li>Support, accompaniment, monitoring and guidance, from initial meeting </li></ul><ul><li>through establishing the local operations and implementation of business </li></ul><ul><li>activity in Brazil. </li></ul><ul><li>Commercial consulting prior to entering the Brazilian market. </li></ul>
  13. 13. Why us? <ul><li>Legal consulting in the Brazilian market. </li></ul><ul><li>Established network of Distributors and end customers. </li></ul><ul><li>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. </li></ul><ul><li>Access to tenders at all governmental levels with vast experience at the Medical Device field. </li></ul><ul><li>Sales hub to south America and Arab countries who won't buy Israeli manufactured products. </li></ul>
  14. 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 .
  15. 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.