The Workbench · Craft
Korea picks a device's reviewer by class, not risk alone
This blog has already covered how Japan's pathway turns on a standard rather than a class, and how China's exemption catalogue changes a file's evidence without changing who reviews it. South Korea's Ministry of Food and Drug Safety sorts devices into four risk classes the way most regimes do, but the class doesn't just set how much evidence a file needs — it decides who is allowed to read that evidence at all. A Class II file and a Class IV file from the same manufacturer can end up in front of two entirely different kinds of reviewer, and only one of them is a government body.
Three tracks, not one review process wearing different badges
Korea's Medical Devices Act, with its enforcement decree and enforcement rule, sets four classes and assigns each a different procedure rather than a different depth of the same procedure. Class I devices go through 제조신고 — a manufacturing or import notification filed with the Medical Device Information and Technology Assistance Center, with no test report or manufacturing-quality certificate required at filing. Class II devices go through 제조인증, a certification reviewed not by MFDS itself but by an MFDS-designated third-party certification body — organizations like the Korea Testing Laboratory or the Korea Testing & Research Institute, reviewing a full technical dossier against methods MFDS has authorized them to check. Class III and IV devices go through 제조허가, a manufacturing approval MFDS reviews directly. A submission plan that treats all three as “get MFDS approval” with more or less paperwork has missed that only one of the three tracks puts the file in front of the regulator at all before a decision is reached.
A private certifier isn't a rubber stamp
The Class II track looks, at a glance, like the kind of self-certification some regimes allow for their lowest-risk devices. It isn't: the certification body is still a gatekeeper MFDS has vetted and designated for a defined scope, working from the same dossier structure and the same test-report and manufacturing-quality expectations a direct MFDS review would demand, and it can refuse a file that doesn't meet them. What changes is which organization is doing the checking, not how much checking happens — a structure closer to how ASCA accredits a lab to run a specific test, without becoming a pathway of its own, than to a manufacturer simply declaring its own conformity.
A foreign manufacturer can't hold its own license
None of the three tracks lets an overseas manufacturer with no Korean entity hold the resulting registration directly. A Korea License Holder — a Korean company that holds the device license, acts as the importer of record, and keeps a registered place of business with a full-time quality manager on staff — has to stand in that role, and stays the party MFDS holds responsible for post-market compliance once the device is on the market. A distribution agreement that treats the Korean partner as a sales channel, without naming which entity is legally answering for the registration itself, has left the license-holder question open on a device that's already shipping.
Two renewal clocks, running independently
Since a 2020 revision to the Medical Devices Act, Class II through IV approvals no longer run indefinitely — they renew on a five-year cycle, alongside the import license itself. A separate quality-system credential, the Korea Good Manufacturing Practice certificate, renews on its own three-year cycle, with the renewal audit due roughly ninety days before the existing certificate expires. The two clocks don't share a calendar: a KGMP certificate can lapse mid-cycle on a device approval that still has years left on its own five-year term, and a compliance tracker keyed to only one of the two dates is missing the one that expires first.
Where this meets the file
A Korea registration tracker needs three fields most single-country trackers don't: which of the three review tracks the device actually went through, which entity holds the Korean license, and both renewal dates kept as separate rows rather than one combined “Korea status” field. A cross-border registration tracker built to carry each market's own review structure and its own renewal clocks, alongside the launch catalog's other device-registration templates, is previewed there now. If your program has run the Class II certification track and found a gap this one misses, the shelf takes that correction directly.
The Regulatory Toolkit launches soon — a free shelf of source-mapped templates, checklists and browser-only tools for regulatory teams. Get one email when it opens, or contribute a template.