GuidelinesImport & customs2026.10.22
When Manufacturer Names and Addresses Differ: Reconcile the Company, Site and Process
The brand owner, test applicant and manufacturing site may be different entities. This guide shows how to map their roles, distinguish a naming discrepancy from a real site change, and retain evidence that explains the product’s manufacturing identity for a Korean registration.
Key takeaway — Establish each company's role and the location of each relevant process before trying to standardize its name. A company–site–process–document map distinguishes presentation differences from manufacturing changes.
Why can one product involve several company names?
The contracting party may own the brand while a different entity manufactures the device. A head office may commission testing, while the report identifies another production location. An outsourced process adds another organization or address. Different names are not automatically errors, and common group ownership does not make all sites interchangeable.
Article 15 of Korea's Medical Devices Act sets out product procedures and quality-system requirements for importers. The relationship between the product, actual manufacturing operations and supporting documents must be understandable. Add roles and locations to the manufacturer document request at the outset.
How should names and addresses be compared?
The following is a working comparison table, not a substitute for the naming requirements of the relevant application form.
| Document or record | Preserve the original information | Difference to explain |
|---|---|---|
| Contract and invoice | Legal name and address of the counterparty | Seller differs from manufacturer |
| Device label | Manufacturing identity, address and model | Brand identity does not identify the operating entity |
| Test report | Applicant, manufacturer and sample identity | Applicant differs from actual manufacturer |
| Quality certification | Certified entity, sites and process scope | Head office differs from production site |
| Process description | Locations for design, production, sterilization and other relevant operations | Outsourced operations and their control |
Do not silently replace several source addresses with one convenient address. Keep the original wording, Korean rendering, explanation and supporting evidence side by side. This separates translation questions from factual discrepancies. Even abbreviated street names should not be standardized without a basis supplied or confirmed by the manufacturer.
How do you distinguish a formatting change from relocation?
Administrative renaming, a company-name change, altered premises within a building and an actual factory move are different events. Obtain the before-and-after identity, relevant date, affected processes and products, and an explanation from the manufacturer.
A new address does not automatically prove a move; an assertion that a change is administrative does not eliminate the need to check it. For products already registered in Korea, compare the existing product and quality-system records to determine the applicable action. This article does not make a blanket decision on amendment or KGMP assessment requirements. Start the case-specific review with our change-control guide.
Where should outsourced processes appear?
A corporate organization chart may not show how the product is actually made. Map the relevant steps—such as material receipt, assembly, inspection, sterilization, packaging and release—to the entity and site performing them. Do not add operations that the product does not undergo.
Distinguish the contractor's work from the manufacturer's controls, then check whether the supporting evidence covers that product and process. If contractual responsibilities and certificate scope differ, obtain an explanation rather than choosing whichever description is more convenient. The broader conformity-assessment framework is covered in our KGMP guide.
What happens to reports and certificates already received?
A new site's document should not erase the history needed to explain the change. Record the applicable models, site, period and replacement reason for each file, and retain superseded versions in a clearly separated state. The most recently received file is not necessarily evidence for the most recent product configuration.
For example, an older address in a test report and a new address in draft labeling require questions about where the tested device was made, whether a move occurred, and whether the product or process changed. Simply editing the label to match the old report conceals rather than resolves the discrepancy.
What should be resolved before submission?
- Each entity's role can be explained in one sentence.
- Relevant processes and sites are mapped to the product.
- Each name or address discrepancy has evidence and a recorded conclusion.
- Affected registration and quality-system records are identified.
- Translations are traceable to originals and their reviewers.
Send the label, certificate, report and product list for a free preliminary review of the discrepancies to resolve first.
Prepared and sources checked: 2026-09-28. Medical Devices Act, Article 15 and related provisions, version effective 2026-07-01; MFDS Medical Device Manufacturing and Quality Management Standards, Notification 2026-46. The comparison table and document-control approach are practical recommendations; device-specific submission and amendment procedures require separate assessment.
Frequently asked questions
- Q. Is a test report unusable if the applicant is not the manufacturer?
- A name difference alone does not determine acceptability. Check the applicant’s role, tested product and manufacturing site, and the right to use the evidence, then assess the explanation required for the Korean review.
- Q. Does a spelling-only address change require no action?
- First establish whether it is a formatting change or a physical move. Its impact on registered particulars and the applicable procedure must be assessed separately, with evidence of the reason for the change.
- Q. Is the head-office address on an ISO certificate enough?
- Check the certification scope and supporting schedules for the actual production site and processes. One head-office address does not establish coverage of every manufacturing location.