Korea is a two-track market. The product needs approval, certification or notification, and the importer needs a business licence. A used unit can satisfy both tracks, but the unit has to fit the approved product, and the local licence holder has to accept the responsibility. Neither track is optional.

Two Tracks: Product and Business

Korea separates the product\’s regulatory status from the importer\’s business licence. The product needs approval, certification or notification under the Medical Devices Act, while the importer needs a licence to conduct the import business. Both must be in place before a unit can be sold.

The MFDS administers the product route and the importer licensing system. The separation exists because the product approval describes the device and its intended use, while the business licence describes the entity that is allowed to import and distribute it. A company cannot substitute one for the other.

For used equipment, the two tracks create two separate questions. Does the unit fit the approved product, and does the importer hold the licence and the product approval for that device? A positive answer to one does not imply a positive answer to the other. Comparable two-track questions appear under FDA rules, the EU Medical Device Regulation 2017/745, TGA requirements and WHO guidance, but Korea\’s answer is set by the MFDS and the licence holder.

Product Approval by Class

Korea classifies medical devices into four classes. Class 1 generally follows notification, Class 2 certification, and Classes 3 and 4 approval, with the evidence and review increasing with the class and the device type.

The class is determined by the device\’s intended use and risk, and the route can vary for specific device types. The product approval or certification identifies the device, the manufacturer and the intended use, and it is held by the local licence holder. A change to the device, the manufacturing site or the intended use can require a change to the approval. The classification should be confirmed against the MFDS rules for the specific device rather than carried over from another market; a device that is Class II in Europe is not automatically Class 2 in Korea.

Importer Licensing

The importer needs a medical device import business licence from the MFDS, covering the device class and the activity. The licence holder is accountable for import, storage, distribution records and post-market obligations.

The licence holder is also the party that holds the product approval or certification. It must have a quality management system for the import activity and must be able to trace the devices it distributes. The foreign manufacturer supports the application with the technical file, the quality-system evidence and the labelling.

A used-equipment transaction should name the licence holder before the unit ships. The licence holder decides whether the unit fits the approved product and whether the condition evidence is sufficient. A buyer that deals only with a broker may not have access to that decision until the unit is already in transit.

Used Equipment: The Acceptance Question

Used equipment is a restricted category in Korea. Some devices may be importable with approval, while others are not accepted, and the position depends on the device, its condition and the current MFDS requirements.

Even where a used unit is permitted, it must fit the approved product and be supported by a condition file: service history, parts replaced, software version, calibration and performance results, accessories and decontamination. The licence holder is the party that presents that evidence and accepts the post-market responsibility.

The practical question is not \”is the device approved\” but \”is this unit eligible, and does the approved product cover it\”. A seller who cannot answer the eligibility question should not invest in shipping or in a registration strategy. The licence holder should confirm the position in writing.

Age and support matter as much as the approval. A unit whose manufacturer no longer supplies parts or software support is a different post-market risk from one still in support, and the licence holder will consider that when deciding whether to accept it. If the unit was refurbished, the scope and test results should be in the file; a cosmetic restoration with no performance evidence is not a condition assessment. That is a file question, not a shipping question, and it should be settled early.

Korean Labelling and Manuals

Labels and instructions for the Korean market must be in Korean and must identify the product approval or certification details, the manufacturer and the importer. A used unit with a foreign label will usually need a Korean label or overlay.

The label must not obscure required information and must match the approved content. An overlay can be acceptable if it is controlled and legible; a replacement label that changes the device identity or the approval details is a different matter. Keep the original label photograph, the approved artwork and the applied result in the unit file.

The manual must match the software version and configuration. A Korean manual for a different version creates a safety and a regulatory problem at the same time. Confirm the language, the version and the completeness of the instructions before the unit ships.

Post-Market Surveillance

The licence holder must operate complaint handling, adverse event reporting, recall and post-market surveillance. Korea also uses re-evaluation and periodic reporting for certain devices, so the file has to stay current after approval.

For used equipment, the weak point is the link between the service record and the manufacturer\’s post-market system. A failure reported to a service company must reach the licence holder and, where required, the MFDS. The record should identify the device, the unit, the symptom, the action and the date.

Recalls depend on traceability. A used unit that changed hands without a record may not receive the notice. The licence holder\’s distribution record is therefore part of the regulatory system, not only a commercial record.

Documentation for a Korean Partner

A Korean partner should receive a file that connects the product approval, the importer licence and the specific unit. The table below is the working set; each missing item should be recorded and assessed rather than replaced by an assurance.

Records and checks: the Korean entry file

Timelines

Timelines depend on the class, the route, the completeness of the technical file and the quality-system review. Notification is faster than certification, and certification is faster than approval; a used unit adds the eligibility and condition assessment before the application can be complete.

Translation, testing, QMS review and any clinical evidence add time. The licence holder\’s review and the MFDS questions add more. A plan that starts from the freight date rather than the dossier date will usually miss the freight date. The export-side sequence is covered in the guide to exporting medical equipment from Hong Kong.

Build the timeline backwards from the intended in-service date: classification, product approval, licence holder appointment, quality-system review, translation, then shipment. Each step should have an owner and a document that proves completion. Where a step depends on the MFDS or a designated body, add review time rather than assuming a fixed period.

The cost drivers follow the same pattern: the route, the evidence, the translation, the QMS work and the licence holder\’s role. A used unit that requires a new approval is a different project from one that fits an existing approval, and the difference should be established before the commercial offer is made.

If you are assessing a Korean route and want the approval, licence and condition evidence reviewed together, send the model and what you already hold to the HHG team. More guides on records, refurbishment and cross-border entry are in the Knowledge section.