Medical Device Registration and Approval Process for South America

Duration: 60 Minutes
Learn how to register your medical devices and gain approval from the regulatory authorities in Brazil, Argentina and Columbia.
Medical Device Compliance
Instructor: David R Dills
Product ID: 501335
Objectives of the Presentation
  • Determine the correct classification for your device, and complete all necessary documentation
  • Evaluate technical and scientific data that demonstrates safety and efficacy of your medical device, and provide guidance regarding acceptability of the information for each country
  • Submit an application and legal documents to the regulatory authorities for review and approval
  • Learn what devices require INMETRO Certification in Brazil
  • Manufacturers without a place of business in Argentina must appoint an in-country representative known as an Argentina Registration Holder (ARH) to submit registration applications and act as liaison with ANMAT
  • Understand how to market your medical device in Colombia and the requirements for registration with the National Food and Drug Surveillance Institute (INVIMA), the country's medical device regulator
Why Should you Attend
Medical devices in Brazil are regulated by the Agencia Nacional de Vigilância Sanitária (ANVISA). Brazil's base regulations and medical device classification schemes are similar to those found in the European MDD 93/42/EEC. The first step in the Brazil regulatory process is to determine the correct classification of your medical device. Lower risk Class I and II devices will follow the Cadastro registration route, which includes a simplified application. Higher risk Classs III and IV devices must follow the Registro registration process. Foreign medical device manufacturers that do not have a physical location within Brazil must appoint a Brazilian Registration Holder (BRH). Your BRH will submit your registration application to ANVISA and maintains control of your device registration and Brazil Good Manufacturing Practice (BGMP) certification, if applicable. Medical device manufacturers looking to sell their products in Argentina must gain approval from ANMAT, the country's medical device market regulator. Medical device manufacturers interested in selling their products in Argentina must gain approval from the Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT), the country's medical device market regulator. As with most countries, determining your device classification is the first step towards registration in Argentina. Argentina uses a four-tier risk system and ANMAT classification rules are very similar to those in the European Medical Devices Directive MDD 93/42/EEC. Manufacturers without a place of business in Argentina must appoint an in-country representative known as an Argentina Registration Holder (ARH) to submit registration applications and act as liaison with ANMAT. Marketing your medical device in Colombia requires registration with the National Food and Drug Surveillance Institute (INVIMA), the country's medical device regulator.

Areas Covered
  • ANVISA Medical Device Registration and Approval in Brazil
  • Brazil GMP (BGMP) Quality System Compliance
  • Some devices listed in RDC 3385/2006 require an Economic Information Report (EIR) compliant with RDC 185/2006 be submitted to NUREM, a division of ANVISA, with the application or within 30 days after its approval
  • Medical Device Registration and Approval in Colombia
  • Medical Device Registration in Argentina
  • Medical device manufacturers looking to sell their products in Argentina must gain approval from ANMAT, the country's medical device market regulator
  • Determine the correct classification for your device, and complete all necessary documentation, to ensure a smooth registration and approval process
  • Prepare all documents that require legalization
  • Mercosur Essential Requirement Checklist and summary of test reports for Argentina
  • Steps to device registration in Colombia and determine the correct classification of your medical device and complete the required steps to bring your device to market
Who can Benefit
  • Medical device and In Vitro Diagnostics manufacturers
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Instructor Profile:
David R. Dills, is an independent Global Regulatory Affairs & Compliance Consultant and has an accomplished record with more than 26 years of experience in regulatory affairs, compliance and quality consultative services for early-stage/established Class I/II/III medical devices, IVD's, and bio/pharmaceutical manufacturers on the global landscape. Previously employed, with increasing responsibilities by device manufacturers and consultancies, including a globally recognized CRO, has worked directly with and for manufacturers engaged in compliance remediation activities involving consent decrees, CIA's, FDA warning letters, and customer generated compliance events, provides Strategic GxP Compliance and Regulatory Consulting, handles all aspects of global regulatory submissions and dossiers, including 510(k), PMA and IDE submissions, serves as a U.S. Agent, works with stakeholders and Center Reviewers regarding submission meetings/negotiations, clinical affairs, and provides regulatory submissions and post-market project leadership/guidance covering different therapeutic and medical specialties based on classification. Background encompasses broad capabilities in regulatory and compliance oversight and governance, regulatory and GxP training, and compliance with MEDDEV/MDD/IVDD Directives. Mr. Dills leads and manages efforts involving multi-country product registrations and licensing in Asia Pacific, EU and The Americas from premarketing to postmarketing, and works with the Regulatory Authorities and strives to provide consistent, practical compliance solutions that work with reduction of regulatory compliance risk.
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