Navigating global regulatory markets in Asia can be a challenge, particularly when each country has unique regulations and requirements. Every country has its own body or system of legal requirements for placing medical devices in the market. Therefore, comprehending the various Asian laws and regulations is the key to registration of products.
This course examines and introduces medical device regulations and registration requirements in China, South Korea, Japan and Singapore. You will learn how to obtain and maintain product approvals, and receive the most up-to-date information about pre-market and post-market regulations.
Topics include product registration, labeling requirements, quality systems, manufacturing and distribution licenses, postmarket surveillance regulations, clearance strategies and time schedules. You will leave this course with a thorough summary of the Asian regulations so you can effectively plan and manage a submission, and actively manage potential registration or compliance issues.