Global Awareness: Emerging Medical Device Markets
RGA6227 / 4 q.h.
Formerly RA 3227.
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. Prereq. RGA 6100, RGA 6202, or RGA 6205.
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