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Homologation and importation of medical products in Brazil - ANVISA
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Homologation and importation of medical products in Brazil - ANVISA


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Homologation and importation of medical products in Brazil - ANVISA

Homologation and importation of medical products in Brazil - ANVISA

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  • 2. DEFINITION Health equipment are those used in the performance of medical, dental, laboratory and physiotherapeutic proceedings; in beauty and cosmetic treatment; diagnostic; treatment and patient’s monitoring. WWW.BRAZILIANLAWBLOG.COM - CONTATO@ADLER.NET.BR
  • 3. DEFINITION Medical equipment are included in the category of health equipment, as per their classification under RDC 185/2001. WWW.BRAZILIANLAWBLOG.COM - CONTATO@ADLER.NET.BR
  • 4. FLOWCHART – STEP 1 HTTP://PORTAL.ANVISA.GOV.BR/ Regularization of the company before the sanitation authorities Company’s operating license (AFE – as per IN 01/94) Municipal operating license (LF – as per local legislation) Good Practices of Manufacturing and Crontrolling (BPFC, as per RDC 59/01) WWW.BRAZILIANLAWBLOG.COM - CONTATO@ADLER.NET.BR
  • 5. FLOWCHART – STEP 1 HTTP://PORTAL.ANVISA.GOV.BR/ Each of the steps described in the previous slide depend on physical adaption of the company’s installations to the laws locally in force, specially phytosanitary and sanitary regulations. WWW.BRAZILIANLAWBLOG.COM - CONTATO@ADLER.NET.BR
  • 6. FLOWCHART – STEP 2 (WORK SHALL BE CARRIED OUT BY OUR FIRM) HTTP://PORTAL.ANVISA.GOV.BR/ Sanitary identification of the equipment. Classification of the equipment (as per RDC 185/01) Is INMETRO certification necessary (as per RDC 32/07)? Is the economical report necessary (as per RDC 185/06)? WWW.BRAZILIANLAWBLOG.COM - CONTATO@ADLER.NET.BR
  • 7. FLOWCHART – STEP 3 (DOCUMENTS) HTTP://PORTAL.ANVISA.GOV.BR/ Identification of the petition Enrollment of equipment (Cap II) Register of Equipment – Class I or II (Cap III) Register of Equipment Class III or IV (Cap IV) Modification of Register or Enrollment(Cap V) Revalidation and other Petition (Cap VII) WWW.BRAZILIANLAWBLOG.COM - CONTATO@ADLER.NET.BR
  • 8. FLOWCHART – STEP 4 (ADMINISTRATIVE PROCEEDINGS) HTTP://PORTAL.ANVISA.GOV.BR/ Electronic Petitioning Delivery of Petition ANVISA’s analysis of the proceedings Publication on the Official Gazette of the Federal Executive WWW.BRAZILIANLAWBLOG.COM - CONTATO@ADLER.NET.BR
  • 9. CLASSIFICATION Equipment are classified into (4) categories, in accordance with the risks they impose to health. Classification is set forth by RDC 185/2001. WWW.BRAZILIANLAWBLOG.COM - CONTATO@ADLER.NET.BR
  • 10. CLASSIFICATION • Class I – low risk • Class II – intermediate risk • Class III – high risk • Class IV – maximum risk. WWW.BRAZILIANLAWBLOG.COM - CONTATO@ADLER.NET.BR
  • 11. CLASSIFICATION In addition to the risk classification, there is the classification by rule, which observes the indication and purpose of the equipment. WWW.BRAZILIANLAWBLOG.COM - CONTATO@ADLER.NET.BR
  • 12. CLASSIFICATION • Non-invasive Products: Rules 1, 2, 3 and 4; • Invasive Products: Rules 5, 6, 7 and 8; • Active Products: Rules 9, 10, 11, 12; and • Special Rules: Rules 13, 14, 15, 16, 17 and 18. WWW.BRAZILIANLAWBLOG.COM - CONTATO@ADLER.NET.BR
  • 13. CLASSIFICATION The description of all classification rules are established under Annex II of the Technical Ruling approved by Anvisa’s Resolution RDC nº 185/01. WWW.BRAZILIANLAWBLOG.COM - CONTATO@ADLER.NET.BR
  • 14. REGULARIZATION TYPES There are (2) two types of equipment regularization before Anvisa: register and enrollment. WWW.BRAZILIANLAWBLOG.COM - CONTATO@ADLER.NET.BR
  • 15. REGULARIZATION TYPES The enrollment is a simpler regularization proceeding, applicable to products of Classes I e II, described on RDC 24/09. WWW.BRAZILIANLAWBLOG.COM - CONTATO@ADLER.NET.BR
  • 16. REGULARIZATION TYPES Medical equipment subject to register, provided that they are not enrolled, are those of risk classes I, II, III e IV. WWW.BRAZILIANLAWBLOG.COM - CONTATO@ADLER.NET.BR
  • 17. REGULARIZATION TYPES Please note that some equipment of Classes I and II shall be registered due to their nature and risk. The list is available at: ex.htm WWW.BRAZILIANLAWBLOG.COM - CONTATO@ADLER.NET.BR
  • 18. REQUIREMENTS The following documents are necessary for register or enrollment: •Operating license issued by the Sanitary Authority; •Operating authorization of the company (AFE) issued by Anvisa; •Certificate of compliance with the good manufacturing and controling practices (CBPFC); •The company shall be registered before Anvisa. WWW.BRAZILIANLAWBLOG.COM - CONTATO@ADLER.NET.BR
  • 19. DOCUMENTS FOR ENROLLMENT CLASSES I AND II 1. Front Page (; 2. Enrollment petition form; 3. Original proof of payment of the sanitary authority’s fee; 4. Comparative table of product for family enrollment; 5. Security and effectiveness for products with innovative indication/purpose or new technology; 6. Proof relating to metrology matters for non-electric equipment with measurement purposes. WWW.BRAZILIANLAWBLOG.COM - CONTATO@ADLER.NET.BR
  • 20. SIMPLIFIED REGISTRY CLASSES I AND II (IN 13/09 AND IN 02/11) 1. Front page (; 2. Technical sheet; 3. Original proof of payment of the sanitary authority’s fee; 4. Label model and instructions of use; 5. Technical report; 6. Register or certificate of free trade of the product abroad; 7. Manufacturer authorization for the sale of the product in Brazil; 8. Specific technical regulation; 9. Annex II of IN 13/09 declaration; 10. CBPFC; 11. Comparative table of product for family enrollment. WWW.BRAZILIANLAWBLOG.COM - CONTATO@ADLER.NET.BR
  • 21. REGISTER CLASSES IV, III AND CLASSES I AND II FOR LAYPERSON’S USE (IN 02/11) 1. Front page (; 2. Form for medical equipment manufacturer or importer; 3. Original proof of payment of the sanitary authority’s fee; 4. Label model and instructions of use; 5. Technical report; 6. Register or certificate of free trade of the product abroad; 7. Manufacturer authorization for the sale of the product in Brazil; 8. Specific technical regulation; 9. CBPFC; 10. Comparative table of product for family enrollment. WWW.BRAZILIANLAWBLOG.COM - CONTATO@ADLER.NET.BR
  • 22. ELECTRONIC PETITIONING The request for register or enrollment of a product before Anvisa begins with the electronic petitioning. In order to go through it, the requesting person or entity shall access Anvisa’s website and fill in the requested information. WWW.BRAZILIANLAWBLOG.COM - CONTATO@ADLER.NET.BR
  • 23. ELECTRONIC PETITIONING The company shall be previously registered before Anvisa, in order to be able to take part of the electronic petitioning proceedings. WWW.BRAZILIANLAWBLOG.COM - CONTATO@ADLER.NET.BR
  • 24. ELECTRONIC PETITIONING Website for electronic petitioning: mas.asp WWW.BRAZILIANLAWBLOG.COM - CONTATO@ADLER.NET.BR
  • 25. ELECTRONIC PETITIONING At the end of the electronic petitioning, a Federal Executive Payment Form is created. It shall be duly paid and attached to the proceedings along with proof of its payment. WWW.BRAZILIANLAWBLOG.COM - CONTATO@ADLER.NET.BR
  • 26. FILING Once the electronic petitioning proceedings are concluded, a hard copy of the petition shall be filed before Anvisa (Unidade de Atendimento e Protocolo), located in Brasilia/DF. WWW.BRAZILIANLAWBLOG.COM - CONTATO@ADLER.NET.BR
  • 27. FILING The filing may be made either in person or by mail. The petition shall be signed by the legal representatives and by the company’s technician responsible. WWW.BRAZILIANLAWBLOG.COM - CONTATO@ADLER.NET.BR
  • 28. FILING Copy of an identification document of the legal representative and copy of the company’s By-laws shall be attached to the petition. WWW.BRAZILIANLAWBLOG.COM - CONTATO@ADLER.NET.BR
  • 29. EXAMINATION BY ANVISA After filing, Anvisa shall verify if the presented documents are in accordance with the sanitary regulations in force. In affirmative case, the registration or enrollment shall be sent for publication on the Official Gazette of the Federal Executive. In negative case, the proceedings shall be rejected or a technical requirement to be complied with the requesting person or entity may be set forth. WWW.BRAZILIANLAWBLOG.COM - CONTATO@ADLER.NET.BR
  • 30. IMPORTING Medical equipment importing is subject to consente by ANVISA. The importer shall register the Importing License (LI) at Siscomex. It shall be available for the purpose of examination by the consenting agency. WWW.BRAZILIANLAWBLOG.COM - CONTATO@ADLER.NET.BR
  • 31. IMPORTING ANVISA shall publish the outcome of the examination within tem working days, in case of Automatic Licensing; and within sixty days, for Non-Automatic Licensing. In both cases, licenses shall be valid for ninety days, for the purposes of shipping the produc abroad. WWW.BRAZILIANLAWBLOG.COM - CONTATO@ADLER.NET.BR
  • 32. IMPORTING As a general rule, the shipping of the product abroad may occur only after the end of the licensing process. Otherwise, the importing shall be subject to the penalties set forth under customs legislation. WWW.BRAZILIANLAWBLOG.COM - CONTATO@ADLER.NET.BR
  • 33. IMPORTING In the case of products subject to consent by Anvisa, the licensing proceeding may be made effective after the shipping of the product abroad, provided that licensing occurs before the begining of the imports customs clearance. WWW.BRAZILIANLAWBLOG.COM - CONTATO@ADLER.NET.BR
  • 34. IMPORTING The customs clearance proceeding for imports is more bureaucratic than the licensing proceeding of the product before Anvisa. Please beware that such proceeding may take a long time. WWW.BRAZILIANLAWBLOG.COM - CONTATO@ADLER.NET.BR