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HOME : Quality Compliance : Re-evaluation & Re-examination

What is Re-evaluation?

When re-evaluation of a medical device is intended under Article 9 of the Act, the MFDS Commissioner shall decide on the products subject to re-evaluation through review by the Medical Device Committee, and publish the followings:

① Products subject to re-evaluation

② Period of application for re-evaluation

③ Content of submitted documents for re-evaluation

What is Re-examination?

If the MFDS Commissioner orders, when granting a product manufacture license, re-examination pursuant to Medical Device Act, the MFDS Commissioner shall mention a period for such re-examination.

· Medical devices which is applied new technology
· Orphan devices