New Health Technology Assessment in Korea — Approved by the MFDS, Still Not Usable in Hospitals

Key takeaway — Being approved yet unusable in hospitals is not a sign that something went wrong. It means there is one more procedure. MFDS approval answers a question about the product; whether the procedure using it can be billed is answered by the Ministry of Health and Welfare through new health technology assessment. Different ministry, different statute, different committee. Four things matter in practice: whether your technology is subject to assessment, the deferral scheme, the 90-day and 250-day deadlines, and the consent and reporting duties that attach during a deferral. Compiled on 8 September 2026 from the Rules on New Health Technology Assessment.

Two doors, opened separately

	MFDS approval, certification or notification	New health technology assessment
What is examined	The product's safety and performance	The safety and effectiveness of the medical technology using it
Basis	Medical Devices Act, Articles 6 and 15	Medical Service Act Article 53; Rules on New Health Technology Assessment
Authority	Ministry of Food and Drug Safety	Ministry of Health and Welfare (supporting work may be entrusted under Article 9 of the Rules, including to the National Evidence-based Healthcare Collaborating Agency)
Outcome	Manufacture, import and sale become possible	A route opens for the procedure to be listed as reimbursed or non-reimbursed

Plan a launch without the right-hand column and you learn only after the certificate arrives that the hospital has no code to bill. The procedure overview covers the left-hand column.

1. Is your technology subject to assessment?

Article 2(1) of the Rules sets out three cases.

1. A medical technology whose safety and effectiveness have not been assessed and which the Minister of Health and Welfare considers requires assessment
2. Among those, a technology whose potential the Minister considers requires assessment
3. A technology already assessed as a new health technology whose purpose of use, target or procedure method has been changed, where the Minister considers assessment necessary

The third is easy to miss. With the same product, changing the indication or the procedure method can bring it back into scope. That is why it belongs in the same review as a change approval.

The first step in the process is not the assessment application but confirmation of whether the item is a reimbursed or non-reimbursed item (Article 3(1)). Only when that confirmation shows it is not an already-listed item does the matter move to assessment.

2. Deferral — the route that brings market entry forward

Article 2(2) creates the deferred-assessment new health technology. Where a technology uses a device, in-vitro diagnostic device or digital medical device that has been approved, certified or notified with the MFDS (the Rules call these "specified devices") for a specified purpose, and meets one of the following four requirements, assessment may be deferred for up to two years.

No.	Requirement
1	There is clinical literature in patients comparing the technology with one falling under Article 3(10) of the Rules
2	Where no comparable alternative exists or the target is a rare disease so that comparative research is impossible, there is clinical trial data under Article 9(2)6 of the Enforcement Rule of the Medical Devices Act
3	For in-vitro diagnostic tests, genetic tests, non-invasive diagnostic tests, or non-invasive technologies with little risk to safety, there is clinical trial or clinical performance test data
4	The technology makes substantial independent use of the device, and the device was approved or certified using clinical evaluation data specified by the MFDS Minister (such devices are announced by the MFDS Minister in consultation with the Minister of Health and Welfare)

Subparagraph 4 allows up to three years, but its period cannot be extended (proviso to Article 2(4)). The other subparagraphs may be extended once, by up to two years.

The Rules also state when deferral is refused (Article 2(3)) — where the device is substantially equivalent in structure, principle, performance, purpose and method of use to one already used in a deferred technology, where the Minister finds a safety concern, or where an assessment has already been carried out.

The outcome of a deferral application is notified to the applicant and to the Health Insurance Review and Assessment Service within 30 days of receipt (Article 3(6)).

3. Deadlines — 90 days and 250 days

Stage	Deadline	Basis
Notification of whether subject to assessment	90 days from receipt	Article 4(1)
Notification of assessment result	250 days from receipt	Article 4(2)
In-vitro diagnostic or genetic tests	140 days	Article 4(2)
Extension of the 140 days	once, by up to 110 days	Article 4(3)
Result of a deferral or extension application	30 days	Article 3(6)

The result goes to the applicant and to the Health Insurance Review and Assessment Service, and the safety and effectiveness findings together with the period, purpose, target and method of use are published by notice (Article 4(2)). Leave this out of the development schedule and a gap of close to a year opens after approval.

4. Duties during a deferral — the practical trap

A deferral is not a period in which nothing is required. Article 3-3 sets out the following.

• Explanation and written consent — the patient must be fully informed of the technology's characteristics, level of evidence, purpose, procedure method, cost and co-payment and adverse effects, and written consent obtained (paragraph 1)
• Monthly reporting — consent and usage must be reported every month to the Minister of Health and Welfare (paragraph 2), from the start of the published deferral period until the assessment result is notified, or until the end of the deferral period where no assessment is applied for
• Immediate reporting — death or serious adverse effects, actual or apprehended, must be reported immediately and records kept (proviso to paragraph 2)
• Suspension of use — use may be stopped where consent was not obtained or reports were not made or were false, and use must be stopped where the committee reports a high level of risk (paragraph 6)

These duties fall on the medical institution, but the reporting forms and the data behind them usually come from the manufacturer or importer. Secure a deferral and then hand the whole burden to the hospital, and that hospital will not adopt your next product.

The Minister of Health and Welfare may ask the MFDS Minister to provide adverse-event data reported under Article 31 of the Medical Devices Act for the purposes of this management (paragraph 3). This is where the two ministries' records meet.

5. Which products run into this

• Therapeutic devices with a new principle of action, where no existing procedure code fits
• In-vitro diagnostic and genetic tests, where the test itself is new — though the deadline is a shorter 140 days and subparagraph 3 of the deferral requirements may apply (IVD guide)
• Standalone software and digital devices, where the form of the clinical act is new (SaMD approval guide)
• Existing products with a widened indication — Article 2(1)3

Conversely, a product used within an already-listed item never meets this procedure. Settling the fork through the reimbursed or non-reimbursed confirmation first is the right order.

Common mistakes

• Scheduling the approval but not the assessment and reimbursement — the gap after approval becomes a revenue gap
• Aiming at deferral subparagraph 4 without seeing the proviso that its period cannot be extended
• Changing an indication or procedure method without checking that it may bring the technology back into scope
• Obtaining a deferral and leaving monthly reporting and written consent entirely to the hospital
• Building a business plan on deferral for a follow-on product that would be refused as substantially equivalent

Pre-application checklist

• Apply for confirmation of reimbursed or non-reimbursed status to establish whether the item is already listed
• If subject to assessment, identify which of the four deferral subparagraphs applies and align the supporting data
• For subparagraph 4, confirm the device appears in the MFDS announcement
• Check the refusal grounds in advance (substantial equivalence, safety concern, prior assessment)
• Build the 90-day and 250-day (140-day for IVD) periods into the launch schedule
• Prepare the consent form and monthly report template in-house to supply to hospitals
• Put an immediate reporting route for adverse events into the company's procedures

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This stretch between approval and market entry gets shorter only if it is designed early in development. Which form of clinical data fits the deferral requirements, and whether your product is a deferral case or an assessment case, is what we check first in a free preliminary review.