Complete Guide to Korean Medical Device Approval — Notification vs. Certification vs. Approval

Key takeaway — In Korea's medical device system, the class determines the procedure: Class 1 = notification, Class 2 = certification, Class 3–4 = approval. So the first question of every project is not "how do we get approved?" but "what class is my product?"

The first gate: is it a medical device, and what class?

Whether a product is a medical device is judged not by its performance but by its claimed intended use. The same massage device raises medical device issues if it claims "improved blood circulation and pain relief," but may not if it carries ordinary consumer-product wording. This is why the wording must be designed before development or importing begins.

The class runs from 1 to 4 by potential risk. Body contact site and duration, invasiveness, energy emission, sterility, and measuring functions are among the factors, and where it is ambiguous, obtaining official confirmation through the MFDS product classification procedure is insurance for the entire downstream schedule.

Procedure comparison by class

Class	Procedure	Review	Typical duration*	Key preparation
Class 1	Notification	None	2–4 weeks	Product specs, labeling — detailed guide
Class 2	Certification	Technical file review (certification body)	3–4 months	Test reports, technical file, KGMP — detailed guide
Class 3	Approval	Technical file review (MFDS)	6–8 months	Class 2 items + advanced data, clinical evaluation if needed
Class 4	Approval	Technical file + clinical review	Can exceed 1 year	Includes clinical trial data

*Practical, experience-based estimates depending on preparation and deficiency rounds; they differ from the statutory government processing periods.

What is common regardless of class

Whatever the procedure is called, the following apply across all classes.

Business requirements — For imports, an import business notification (including a quality manager); for manufacturing, a manufacturing business license — is the prerequisite for the product procedure. See the import process guide for details.

GMP — For Class 2 and above, KGMP conformity assessment effectively comes as a package. Even some Class 1 products, such as sterile devices, fall within scope as exceptions. The KGMP guide covers each audit type.

Labeling and advertising — Korean labeling is a common obligation across all classes, and advertising cannot exceed the approved intended use.

Post-market obligations — Issuance is not the end but the beginning. Change management, renewals, and adverse event reporting follow.

A step-by-step order for first-time applicants

1. Fix the intended-use wording → judge whether it is a medical device
2. Fix the product name and class → find your procedure in the table above
3. Design business requirements and the product procedure in parallel — running them sequentially delays you by exactly that much
4. Move to the class-specific detailed guide — prepare testing, documents, and GMP
5. Include labeling and advertising review in the launch schedule

The 3 most expensive mistakes

Misjudging the class — Signing the goods contract believing it is Class 1 when it is Class 2. Testing, certification, and KGMP costs plus months are added.

Deprioritizing business requirements — Finishing all the product documents only to find the filing cannot be accepted because the import business notification is missing.

Overreaching on intended use — Broadening the claims out of marketing ambition, triggering a chain of class escalation, clinical requirements, and advertising sanctions.

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What class your product is, and which procedure applies — this first judgment sets the size of the entire project. Send your product specifications and intended claims for a free pre-review, and we will confirm the class and the regulatory roadmap.