Medical Device Regulatory Requirements in Latin American Countries

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

Event Details

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

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

Organization Details

Online Compliance Panel (OCP) creates and delivers comprehensive industry relevant training sessions. These sessions are simple, interactive and cost effective. We are a predominantly web based information exchange forum. Live interactions on compliance training make the process holistic and effective. OCP largely emphasizes in offering regulatory compliance training to compliance professionals on varied topics. These primarily include risk management, quality management, corporate compliance and other regulatory compliances. Some of our primary areas of focus include advancement and updates in regulatory compliance, best practices and market trends.

We strive to incorporate high standards in developing a culture facilitating exchange of ideas resulting in functional excellence. OCP believes in nurturing ideas and thought processes through innovative e-learning methodologies. Our products and services are designed to offer customized solutions to industry and market. We bridge the gap between experience and knowledge thus delivering original and creative content.

Our objectives of employing interactive mediums ensure effective communication and mutual exchange of ideas. OCP closely follows best practices and regulatory trends in the global compliance scenario. We also observe and communicate trends witnessed in FDA, ISO regulations, process and design validation. All updates and additions to important laws can be accessed by our customers in real time.

Our mission is to empower compliance professionals through effective online training sessions. Our world class training methodologies stem from comprehensive understanding of client requirements. The content conforming to FDA and ISO standards is developed by well qualified and experienced industry leaders. Our offerings will exceed expectations and add value to your investment.

The content in various categories such as medical devices, pharmaceuticals and biotechnology will raise the bar in terms of quality already on offer .We hope to contribute to the creation of responsible organizations creating benchmarks in quality, integrity and transparency.

Online Event
38780 Tyson Lane, Apt 210
Fremont, CA 94536

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

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Contact Information

Organization: Online Compliance Panel LLC

Event Contact: OCP Panel

Phone: 15108575896