Emerging Medical Device Markets

RGA 6227 4 Quarter Hours
Course Level CPS - Graduate
Description Covers the Common Technical Documents, General Guidance, GMPs, and Global Harmonization Task Force (GHTF) documents for medical device requirements in emerging markets. The United States., European Union, Japan, Canada, and Australia comprise the five founding member countries of the GHTF. Yet, the most vibrant and challenging regulatory arenas of medical device development are those in emerging markets (e.g., the Pacific Rim, East Asia, the Middle East, and South America). Offers students an opportunity to practice putting together a medical device submission, identify two submission pathways per product classification, and outline the postmarket requirements. These practical lessons and regulatory skills are an asset to any regulatory professional in the global marketplace.

Prerequisites

Students should refer to the CPS Prerequisite Table for course prerequisite and corequisite information.

 

Course Sections

There are no current sections scheduled for this course. Undergraduate course numbers changed beginning with the Fall 2016 term. Please make sure you are using the current course number.
Next Term Starts
  • Winter Graduate
    Jan 8, 2018 (6- and 12-week classes)
    Feb 19, 2018 (6-week classes)

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