Global Medical Device Regulatory Submissions - The Marketing Application Process
PHAR 6380E
3 hours
Global Medical Device Regulatory Submissions - The Marketing Application Process
Course Description
Overview of the regulatory process for marketing medical devices
among countries on a global basis, including a review of major
regulations and agencies in the various countries that are
responsible for overseeing the marketing of medical devices.
Athena Title
Global Medical Device Marketin
Non-Traditional Format
This course will be taught 95% or more online. Three hours per
week for fifteen weeks online study, including teaching,
assignments, discussion, problem-based learning, and case-based
learning. Weekend seminar(s) totaling eight contact hours
(onsite or web, video conference) utilizing case-based and
problem-based learning methods.
Prerequisite
PHAR 6010 or PHAR 6010E or permission of department
Grading System
A - F (Traditional)
Student learning Outcomes
Students will describe the major regulations that govern the marketing of new medical devices among the various countries.
Students will define the risk classification system used among international countries to classify medical devices.
Students will summarize the similarities and differences in regulations for various types of medical devices.
Students will demonstrate the ability to locate essential reference materials associated with regulatory compliance among various international countries.
Students will evaluate and interpret the subjective and interpretive aspects of the regulations.
Students will examine and analyze the implications of regulatory submissions for facility compliance and quality system standards.
Topical Outline
A review of major regulations and agencies in the various countries that are responsible for overseeing the marketing of medical devices.
The goal is to provide the foundational information to allow the student to develop a basic understanding and knowledge of the medical device industry on a global scale as it relates to the process for marketing devices in compliance with the published regulations.
This course will be broken down into regional content modules, including sub-Sahara Africa, North Africa, Middle East, Europe (EU), Europe (non-EU), East Asia, South Asia, Oceania, Latin America, and North America.
