Medical Device Manufacturing Licence in Korea — Company Licence and Product Approval Are Separate

Key takeaway — The two terms most often conflated in Korean medical device work are manufacturing licence and product approval. The manufacturing licence is a company-level permit granted per manufacturing site (Medical Devices Act Article 6(1)); product approval, certification and notification run at the item level. Different requirements, different reviewers. Run them in sequence and the timeline doubles; design them in parallel and it roughly halves. Current as of September 2026.

It starts with treating two permits as one

When someone asks "how long does manufacturing approval take," the honest reply is a question back: do you mean the company licence or the product approval?

The two divide like this:

	Manufacturing licence	Item approval / certification / notification
Unit	Per manufacturing site (company, premises)	Per product (item)
What is examined	Facilities, personnel, quality management system	Whether that product is safe and performs
Basis	Medical Devices Act Article 6(1)	Article 6(2) — splits into approval, certification or notification by class
Output	Manufacturing licence	Item approval, certificate or notification receipt

Both are needed before a product reaches the market. With only the licence you are entitled to manufacture but have nothing to sell; with only the item track there is no entity to manufacture.

And there is an important practical consequence — the two sets of requirements do not overlap, so they can run at the same time. While you build out the facility and appoint a quality manager, the technical file and testing can proceed. That is where the schedule saving comes from. How notification, certification and approval divide by class is covered in the procedure overview.

First — which business are you in

Before looking into a manufacturing licence, settle one thing: is it actually manufacturing?

Business	What it does	Basis
Manufacturing	Makes devices at a manufacturing site	Manufacturing licence (Article 6(1))
Importing	Brings in devices made abroad	Import business licence (Article 15(1))
Distribution	Distributes and sells domestically	Sales business notification

The common misconception sits right here. Putting your own brand on a finished device made in an overseas factory is often assumed to be manufacturing — but the licence is granted per manufacturing site, which presupposes a site in Korea. Without a domestic site, bringing in finished goods falls under importing.

The reason this comes first is simple: the business category changes the facility standards, the document set and the cost. Discovering after signing a lease that you were never a manufacturer turns that lease into sunk cost. The distribution side is covered separately in the sales business notification guide.

The three axes a manufacturing licence examines

1. The site — facility standards

The basis is Article 8(1) of the Enforcement Rule and Annex 2, the standards for facilities and the manufacturing and quality management system. What work areas, storage and testing space are required comes from there.

The practical sequencing point: read Annex 2 before signing for premises. What kind of space is required varies with the product you intend to make, and an existing building's layout may be hard to adapt. Finding out after the contract means either conversion cost or looking again.

For importers, Article 31(1) and Annex 4 are the corresponding provisions.

2. The person — quality manager

At least one quality manager per manufacturing site is required (Enforcement Rule Article 11(1)). It is an application-stage requirement, so without that person nothing starts.

And this is frequently the longest lead item. Ten eligibility routes are open, so there are more options than people expect, but confirming which route applies and assembling the evidence takes time. Eligibility, the restriction on holding other duties, and the training obligation are covered in the quality manager guide.

Do not reverse the order. Check the person before you look at premises — premises can be solved with money and time, eligibility cannot.

3. The system — KGMP

Conformity to the manufacturing and quality management standards, commonly called KGMP. As the title of Annex 2 shows, facilities and the quality management system are treated as one package.

KGMP is not a documentation exercise but the work of making the company actually operate that way, so it takes time and exchanges values with the item track. See the KGMP guide.

If you are considering contract manufacturing

Outsourcing part of the manufacturing process is common in practice. One principle is firm, though — outsourcing the process does not outsource responsibility for quality.

So even with a contract structure, how the contractor is selected and monitored, and how that is recorded, has to sit inside the quality management system. "We outsourced it, so it is not ours" does not hold.

If what you are considering is a structure with no domestic manufacturing site at all, that is not a contract-manufacturing question but the business category question above. Check whether importing is the right design first.

Designing the schedule

Because the two tracks are separate, they can be parallelised. A workable order:

1. Settle the business category — manufacturing or importing
2. Start on the person — confirm the quality manager's eligibility route (longest lead time)
3. Fix the item — item name and class. This result drives both the facility requirements and the item pathway
4. Run in parallel — (facility build + quality system) ∥ (technical file + testing)
5. Close out — manufacturing licence, then the item track

Step 3 is the fork. Only once item and class are fixed do you know what Annex 2 requires and whether the item pathway is notification, certification or approval. Building the facility before fixing the item is the most expensive mistake available.

Common mistakes

• Obtaining the licence and deferring the item track — entitled to manufacture, unable to sell
• Signing for premises before item and class are fixed
• Leaving the quality manager to last and delaying the application
• Preparing as a manufacturer while importing finished goods, then switching late to importing
• Assuming that outsourcing a process transfers quality responsibility with it

Before you start

• Determine which applies: manufacturing / importing / distribution
• Fix item name and class → confirm the item pathway (notification, certification, approval)
• Identify the quality manager candidate's eligibility route and whether evidence can be obtained
• Before contracting, compare Annex 2 facility standards against the candidate premises
• Decide when KGMP work starts — plan it against the item track
• Where processes are outsourced, build contractor selection and oversight into the quality system
• Draw up a parallel schedule for the licence and the item track

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Whether to start as a manufacturer or an importer, and what to parallelise when, only resolves once the item is fixed. Tell us what you intend to make and the business shape you are planning, and we will confirm which category fits and what to start on first — see free preliminary review.