Requesting Registration Documents from an Overseas Manufacturer: Agree the Model and Revision First

Key takeaway — Start the request with a defined Korean model and manufacturing site. For each document, ask for its applicable configuration, revision and owner. The tables below are preparation tools, not a universal statutory submission checklist.

Have both sides agreed which product is being discussed?

Article 15 of the Korean Medical Devices Act distinguishes the importer's business authorization from the procedure for the imported device. Keep company credentials separate from the evidence supporting the particular product. The wider sequence appears in our Korean registration guide for overseas manufacturers.

At the top of the request, list the intended Korean model, intended use, user, use environment, software revision, supplied accessories and actual manufacturing site. Where a decision remains open, identify its owner and expected decision point. A brochure's family name is not a sufficiently precise reference: both parties may otherwise accept a report for a different configuration without noticing.

What belongs in the first request table?

Give each row an internal review status such as required, further assessment or not applicable. The actual submission scope depends on the device and Korean procedure; every example in this table is not automatically a legally required attachment.

Where should the review of a test report begin?

Read sample identification and the scope of the conclusions before relying on the report title. If the tested model differs from the proposed import, request a comparison and assess whether the tested configuration represents it. Similar housings can conceal changes in power supply, patient-contact material or software.

For example, a manufacturer might submit one report for models A and B. Ask for the differences, tested configuration and exclusions, rather than accepting a statement that both are in one series. Our guide to using foreign test reports explains the separate question of applicability in Korea.

How can confidential evidence be handled?

A refusal to provide a file may mean that it does not exist, a test laboratory controls it, internal approval is pending, or the manufacturer is concerned about trade secrets. These situations require different actions and lead times.

Agree the authorized recipients, storage location, access permissions, translation or excerpting rights, and permission to use the evidence in subsequent responses. If direct delivery to a reviewing organization is proposed, verify the accepted route and recipient before relying on it. Keep important records in an approved shared repository and receipt register, rather than only in one employee's mailbox.

Does a gap immediately mean a new test?

First distinguish availability, applicability and completeness. A missing appendix, an unexplained model difference and an unperformed test are different gaps. Ordering a new test before determining which problem exists can commit expenditure before the product scope is settled.

Record document title, revision, issue date, applicable models, reviewer, unresolved questions, action owner and target reply date. When a new revision arrives, compare the changes instead of automatically carrying forward the previous conclusion. Link the request register to the technical file sections so each explanation has identifiable evidence behind it.

Five checks before sending the request

• Both parties use the same Korean model and sales configuration list.
• Each report can be traced to a sample, revision and manufacturing site.
• Reasons for unavailable evidence and the responsible person are distinguished.
• Evidence-use rights and a contact for subsequent questions are agreed.
• Receipt, review conclusions and follow-up requests remain in one register.

Send the specification and current document inventory for a free preliminary review of the next evidence requests.

Prepared and sources checked: 2026-09-28. Sources: Medical Devices Act, Article 15 and associated provisions (version effective 2026-07-01); MFDS registration procedure. The request table and review sequence are practical suggestions and do not replace a device-specific statutory checklist.