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Medical Device Regulatory Requirements in Latin American Countries

Tuesday, May 02, 2017 at 10:00AM - 1:00PM

Online Event

  • May 2017

    02 Tue

    10:00AM

  • May 2017

    02 Tue

    1:00PM

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Medical Device Regulatory Requirements in Latin American Countries

Tuesday, May 02, 2017 at 10:00AM - 1:00PM

Fremont, CA

No tickets available

Description
Mexico is the second largest medical device market in Latin America behind Brazil, and can prove to be a profitable target for medical device and IVD manufacturers. Determining classification of your device using rules found in Annex II of Resolution RDC 185/2001 published by ANVISA Registering a device or IVD in Mexico can be challenging. COFEPRIS, the division of the Mexican Ministry of Health (Secretaria de Salud) is responsible for medical device and IVD oversight. Medical devices in Brazil are regulated by the Agência 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. Appoint a company that holds a Company Working Allowance permit from ANVISA as your Brazil Registration Holder (BRH).Registering a device or IVD in Mexico can be challenging for non-Spanish speakers.

COFEPRIS has two options for device registration and approval process: Equivalency Review Process and Standard Review Process Prepare and submit registration application documents to COFEPRIS and ANVISA.

Objectives of the Presentation
  • How long does it generally take for approval?
  • Can I transfer my registration to another company?
  • Determine the correct classification for your device, and complete all necessary documentation, to ensure a smooth registration
  • Understand that foreign medical device manufacturers that do not have a physical location within Brazil must appoint a Brazilian Registration Holder (BRH)
  • Identify the required documentation for your registration route
  • Appoint or designate your independent Mexico Registration Holder
  • Prepare and submit registration application documents to the Regulatory Authorities
  • Coordinate translation of all testing reports and clinical data into Spanish
Why Should you Attend
  • Learn how to access new markets and obtain medical device approval in all the countries listed
  • Complete your registration in order to obtain medical device approval as efficiently as possible while realizing that some markets/countries will be more challenging
  • Navigate the regulatory system, achieve product registration and access the medical market
Areas Covered
  • Determine the proper regulatory pathway for your devices and the documentation required within the applicable registration route for Mexico
  • Determine classification of your medical device and determine a grouping strategy for your registration in Mexico and prepare and submit registration application documents to COFEPRIS
  • Determine the proper regulatory pathway for your devices and the documentation required within the applicable registration route with ANVISA in Brazil
  • Certain devices require INMETRO Certification in Brazil
  • Brazil has four classes of devices with ascending risk, and two registration pathways: Cadastro and Registro
  • What products require ANVISA Good Manufacturing Practices inspection
  • Does ANVISA allow third party organizations to audit to BGMP?
  • COFEPRIS: Medical devices are classified based on increasing risk using a 3-tiered system: Class I, Class II, and Class III.
Who will Benefit
  • Regulatory personnel whose responsibilities require knowledge of Latin America's regulatory environment
  • Administrative staff responsible for ensuring compliance with regulatory filings and overall regulatory compliance requirements will also find this training highly relevant
  • QA / QC Personnel
  • Global Supply Chain personnel
  • Medical Device personnel
  • Manufacturing personnel
  • Global Business Development personnel
  • Any sales or general management employee requiring an understanding of how regulations and compliance issues impact the organization will also benefit
For Registration
http://onlinecompliancepanel.com/webinar/MEDICAL-DEVICE-REGULATORY-REQUIREMENTS-505981/MAY-2017-ES-EZEVENT

Note: Use Promo code WE3PL and get 10% off on registration (Valid till MAY 31st 2017)

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