South Korea medical device registration resources

The Government24 service record puts the processing period at 즉시 — immediate, within 3 working hours — so this is a same-day filing rather than a review

It used to be a 10-day review. The Enforcement Rule amendment that took effect on 8 April 2012 converted Class I from a reviewed notification into acceptance-on-filing

Filed to the Korea Institute of Medical Device Safety Information through the e-Medis portal, not to a regional MFDS office

A Class I device that is not substantially equivalent to anything already authorised is pushed out of the notification route and into full approval (Enforcement Rule Art. 4)

Five days is the certification decision only. The technical-document review that must precede it is a separate application to a designated review body, and the K-GMP conformity assessment is separate again — those are what make the practical elapsed time months rather than a week

Korea counts a period of 5 days or less in hours from the moment of receipt, excluding Saturdays and public holidays, so this is a working-day figure

Certification is delegated to the Korea Institute of Medical Device Safety Information rather than performed by MFDS itself

Some Class II devices are carved out of certification and sent to full MFDS approval instead: combination products with a drug or quasi-drug, u-Health devices, continuously worn respiration monitors under tracking management, daily-wear hard and soft contact lenses, devices in the joint device-approval/new-health-technology process, devices that are not substantially equivalent or need clinical data, and devices whose sub-classification has not been published

Applies where no technical-document review is needed: export-only approvals whose intended use has been checked, and items proven identical to an already approved product

MFDS bands the approval clock by how much review the dossier needs, not by risk class — the same 10/65/80 ladder governs Class III and IV items and the minority of Class I and II items that are pushed into the approval route

The standard route for a Class III or IV device that does not need clinical data

A preliminary review runs first; where the attachments do not meet the requirements the applicant gets 5 days to supply what is missing

Periods of 6 days or more are counted in days from the date of receipt, excluding Saturdays and public holidays