What Is The Role Of The MFDS In Medical Device Approval In South Korea?

The MFDS plays a vital role in medical device approval in South Korea by evaluating safety, efficacy, and quality through a rigorous review process. It classifies devices based on risk, requires comprehensive documentation for pre-market submissions, conducts facility inspections, and monitors post-market performance, ensuring that medical devices meet regulatory standards for public safety.

Leave a Reply

You must be logged in to post a comment.