Can Overseas Test Reports Be Used for Korean Medical Device Registration?

Key takeaway — The answer to "can we use overseas test reports in Korea" is not yes or no. It is "which test, and issued under what conditions." Electrical safety and EMC have an international recognition route in the IECEE CB Scheme; biological safety has a separate gate in GLP and OECD mutual acceptance; performance testing is generally reviewed again against Korean standards. Most deficiency letters arise not because a report is missing, but because a report exists and its conditions do not match.

The sentence we hear most often in import registration consultations is this: "Our manufacturer has the CE mark and all the test reports. We can just use those, right?" Half right, half wrong. Each type of test has its own recognition route, and even two CB reports can differ in usability because of a single standard edition. This guide sets out what is recognized, what has to be repeated, and why data that looks perfectly sound gets rejected — from the reviewer's point of view. If the overall procedure is still unclear, start with the difference between notification, certification and approval.

Each type of test has its own recognition route

Treating "overseas test data" as one undifferentiated block is a guaranteed source of confusion. Split the testing into three tracks and assess the recognition conditions for each.

Test category	Representative standards	How it is recognized in Korea	Practical difficulty
Electrical / mechanical safety, EMC	IEC 60601-1, IEC 60601-1-2	Recognized via the IECEE CB Scheme (CB reports from accredited laboratories)	Relatively straightforward
Biological safety	ISO 10993 series	GLP compliance + data covered by OECD Mutual Acceptance of Data (MAD)	Demanding conditions
Performance testing	Product-specific standards	Generally reviewed against Korean standard conditions	Retesting is common

The core point: electrical safety has a "test once, recognize each other" system; biological safety has a "we only accept data from qualified GLP facilities" system; and performance is closer to "we look at it again by our own standards." Blur these three together and your document package will not line up with what is actually required.

Electrical and EMC — the CB report as an international route

Electrical and mechanical safety and EMC are where overseas data works best. The basis is the IECEE CB Scheme. A CB report (CB Test Certificate plus CB Test Report) issued by a participating accredited laboratory after testing to IEC standards is designed on the premise of mutual recognition among member countries. If your manufacturer already holds CB reports to IEC 60601-1 and IEC 60601-1-2, there is a good chance they can be used directly in the Korean filing.

But "it's a CB report, so it passes" is a misconception. What trips up projects in practice is not the report itself but the conditions attached to it.

1. Standard edition and amendments — Requirements under IEC 60601-1 differ by edition and amendment. A report issued against an older edition may not line up with the criteria currently recognized in Korea.

2. National Differences — Check whether the Korean national difference items were covered and tested in the CB report. If that section is blank, you may be asked for additional difference testing.

3. Model and configuration match — The model name, ratings and option configuration on the report must match the model you are filing. Trying to cover a family of derivative models with a single report is a common cause of rejection.

The review framework for electrical medical devices follows the same flow as the Class II certification guide. If your product includes software, IEC 62304 and cybersecurity requirements are added on top, so review the software cybersecurity assessment guide as well.

Biological safety — GLP as the qualification gate

Any product that contacts the human body needs biological safety data from the ISO 10993 series. Here, whether overseas data can be used comes down to who issued it.

In Korea, biological safety test data must come from a laboratory operating under GLP (Good Laboratory Practice). A report from an ordinary testing house, however polished, is unlikely to be accepted as registration data. For overseas data, the gate is whether it was issued by a GLP facility within the OECD Mutual Acceptance of Data (MAD) framework. GLP-compliant data from OECD member states and countries covered by mutual acceptance can be reviewed in Korea; data from outside that framework frequently ends up being retested.

There is one more practical trap here: contact type and contact duration in the report differing from the actual product. Under ISO 10993-1, the required endpoints are determined by "which tissue it touches, and for how long." If the manufacturer obtained the report on the basis of a different categorization, it will not match your product's contact scenario and endpoints will be missing. When reusing biological safety data, you also need chemical characterization and material information (down to the raw materials of contacting parts) on hand to judge the gap. For sterile products, the same logic applies to condition matching in ISO 11135 (EO), ISO 11137 (radiation) and ISO 11607 (sterile packaging) documentation.

Performance testing — closer to "we look at it again by our own standards"

Performance testing is the area where overseas data works least well, because the test conditions in product-specific Korean standards often differ from those behind the overseas report. If the measurement method, acceptance criteria or test environment diverge from the Korean standard, retesting is required for mismatched conditions no matter how good the numbers are. This shows up sharply in performance-driven product categories such as nebulizers — the same bottleneck flagged repeatedly in the nebulizer guide. The same applies to categories where performance and safety are intertwined, such as rehabilitation robots.

Five things to verify up front

Checking these five points before you accept a report will head off most deficiency letters.

Check item	What to look at	If it does not match
Standard edition / amendment	The edition and amendment of the standard cited in the report	Mismatch with current criteria → difference testing
Test conditions	Measurement method, acceptance criteria, environmental conditions	Mismatch with Korean standards → retesting
Model / option match	Whether the model name on the report matches the filed model	Derivative models not covered → additional testing
Laboratory qualification	Accredited laboratory status, GLP status	Unqualified data → not recognized
Issue date	When the report was issued	Data that is too old → re-confirmation requested

Screening the data — from inventory to gap analysis

The right way to use overseas reports is not "submit everything we have" but selection. The sequence looks like this.

1. Inventory — List the reports the manufacturer holds by test type, standard, edition, issue date and model. At this stage it is important to secure the original full reports attached to the CE technical documentation, not summaries.

2. Gap analysis — Compare against Korean standards and required endpoints, and sort everything into three columns: "acceptable," "conditions to be confirmed," and "retest." This table becomes the backbone of your budget and schedule.

3. Securing and commissioning — For the data you keep, prepare originals, translations and notarization; commission testing in Korea only for the retest items. This interlocks with technical documentation preparation, so running it alongside the technical documentation guide cuts wasted effort.

For imported products this also ties into customs clearance and labeling schedules, so see the import and customs guide. If the terminology is unfamiliar, the technical documentation and KGMP glossary entries will help.

Common grounds for rejection and deficiency letters

• The standard edition of the CB report does not match the criteria currently recognized
• Model name, ratings or options on the report do not match the filed model (derivative models forced under one report)
• Biological safety data issued by a non-GLP facility → not recognized
• ISO 10993 contact type or duration differs from the actual product, leaving endpoints missing
• Performance test conditions differ from the Korean standard → condition mismatch
• Summaries or extracts submitted instead of the original full report
• The testing laboratory does not hold accredited laboratory status

Checklist before you start

• Inventory of reports on hand compiled (test type, standard, edition, issue date, model)
• Coverage of Korean National Differences in the CB report confirmed
• GLP status and OECD mutual acceptance coverage of biological safety data confirmed
• ISO 10993 contact type and duration cross-checked against the actual product
• Model names and options on the reports matched against the filed model
• Gap analysis against Korean standards → sorted into acceptable / conditions to confirm / retest
• Documents requiring originals, translation and notarization listed; only retest items commissioned

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Even within one manufacturer's file, each type of test has its own recognition route, and a report that looks perfectly sound can be unusable over a single condition. Send us the manufacturer's report list and the product specification, and our free pre-review will separate the data you can keep from the tests you need to redo. For an outline of the required test scope and an indicative schedule, see our regulatory services.