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REGULATORY AFFAIRS IN LATIN AMERICA FOR MEDICAL DEVICES


Starting 23 - 24 February 2022
LIVE Online Course
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REGULATORY AFFAIRS IN LATIN AMERICA FOR MEDICAL DEVICES


Starting 23 - 24 February 2022
LIVE Online Course

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 * Day One
 * Day Two

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DAY ONE


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DAY ONE

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Session 1: Introduction to medical devices in Latin America
 * Working with the national authorities in the region
 * Strategies for coordinating regulatory operations in Latin America
 * Overview of the competitive landscape in the region
 * Mutual recognition agreements and harmonisation in the region



Session 2: Overcoming regulatory challenges in Brazil, Mexico and Argentina
 * Evaluating the regulatory requirements and procedures in Brazil: FDA/EMA vs
   ANMAT vs COFEPRIS vs ANVISA 
 * Managing future changes to the regulations 
 * Classification of devices 
 * Strategic guidance on device registration, including dossier preparation: 
   * Dossier requirements 
   * Data requirements 
   * Timelines
 * Lifecycle management including variations and renewals: managing material,
   design and manufacturing changes 
 * Interpreting labelling and packaging requirements 
 * PMS and Vigilance 
 * Reporting and follow-up responsibilities



Interactive exercise

Delegates will work through a medical device dossier for one of the countries
discussed, either Brazil, Mexico or Argentina, overcoming the problems that have
been addressed.



Session 3: Overcoming regulatory challenges in Brazil, Mexico and Argentina
 * The GMP inspection for class II and III devices 
   * Why is this process so time-consuming? 
   * Assessing the Medical Device Single Audit Program (MDSAP) led by the IMDRF:
     how will it speed up the inspection process? 
 * Exploring how approval in the US, Canada, Japan and Korea will speed up your
   application in Mexico



Practical Exercise

Delegates will be taken through various case studies for Brazil, Mexico and
Argentina to highlight various regulatory aspects from dossier preparation and
classification to labelling and PMS.



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