What Are The Responsibilities Of The MFDS In Medical Device Regulation?

The responsibilities of the MFDS in medical device regulation include evaluating pre-market submissions for safety and efficacy, classifying devices based on risk, conducting facility inspections for Good Manufacturing Practices (GMP) compliance, and overseeing post-market surveillance. The MFDS also develops guidelines for clinical trials, labeling, and advertising to ensure public safety and health.

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