엠디웍스코리아

Product Notification, Certification & Permits

Class	Document preparation	Review process and outcome
Class I	Prepare notification application	National Institute of Medical Device Safety Information5 days Notification accepted
Class II	Prepare technical documentation Prepare supporting materials GMP conformity assessment certificate Copy of outsourcing agreement (if applicable)	Technical documentation review body25 days National Institute of Medical Device Safety Information5 days Certificate issued
Class II		Ministry of Food and Drug Safety (MFDS) Technical documentation review: 55 or 70 days Approval10 days Approval certificate issued
Class III–IV	Prepare technical documentation Prepare supporting materials GMP conformity assessment certificate Copy of outsourcing agreement (if applicable)	Ministry of Food and Drug Safety (MFDS) Technical documentation review: 55 or 70 days Approval10 days Approval certificate issued

* For certain Class II devices subject to clinical data review, and licensable products such as contact lenses, submit an approval application to the MFDS.

** Where clinical data review applies, the technical documentation review period is 70 days.