Korean Medical Device Certificates — Issue, Lookup, Reissue, Changes and Transfer

Key takeaway — A request for an MFDS certificate can mean several different documents. Separate company status, the registered product scope, and the current holder and status. Replacing a document is different from changing its underlying particulars or transferring the business.

Which certificate has the customer requested?

A manufacturing or import business licence concerns the company. An item licence, certification or notification concerns the medical device. A sales-business notification and KGMP conformity documentation have different roles again. Ask whether the recipient is verifying the supplied product or the supplier's business status.

Purpose	Document and details to compare
Manufacturer or importer status	Business licence: company name, address and licence number
Coverage of the supplied model	Item certificate and attachments: model, intended use and scope
Manufacturing and quality system	KGMP conformity documentation for the relevant scope
Notified distribution business	Sales or rental business documentation for the establishment

The overseas manufacturer and the Korean registration holder may differ. Our KLH and ICC guide explains that ownership structure.

What should be retained after initial issuance?

After the applicable notification, certification or approval procedure, retain the certificate and its registered attachments as one controlled record. A cover page alone may omit model lists, intended use, specifications and amendments needed to compare the certificate with the supplied product. The initial regulatory sequence is described in the seven-step Korean registration path.

A useful register records document type, legal holder, number, product and model, initial issue date, latest change, applicable validity or renewal status, original storage location and recipients of copies. This is an operational recommendation, not a rule that every certificate has the same validity period. Item renewal and company business licensing should not share an undifferentiated calendar.

What can a public lookup establish?

Do not stop at a matching trade name. Compare the licence, certification or notification number, holder and model. Similar names can refer to different manufacturers, holders or versions. Obtain the latest attachments and amendment history from the holder where the public record does not show them. Our integrated information system guide explains the relationship with product-identification records.

A lookup is a starting point for checking information, not automatically the official evidence a recipient requests. Article 63(3) provides a separate Form 53 procedure for confirmation or certification of registered particulars. A translation is included for a foreign-language request, so define the destination, required language and purpose before preparing the submission.

Where should a lost or damaged document be reissued?

Article 63(1) addresses reissue for loss, unusability, changed particulars and other recognized reasons. Form 52 is accompanied by the existing certificate, except where the document was lost. The receiving authority depends on the document:

Document	Authority specified by Article 63
Manufacturing or import business licence	Regional MFDS office for the establishment
Item manufacturing or import licence	MFDS
Item certification or notification certificate	National Institute of Medical Device Safety Information
Repair, sales or rental business notification certificate	Local authority for the establishment

An unavailable document and an invalid registration are different problems. Reissue does not cure a revoked registration or resolve an outstanding validity question. Establish the document type, number, holder and reason before filing.

Is reissue enough when an address, product or holder changes?

Distinguish change approval, change certification or change notification under Article 12 from document reissue under Article 63. Where the registered facts change, first identify the applicable change procedure. Reissue does not independently validate the underlying change.

Prepare a before-and-after comparison covering company particulars, models, manufacturer, intended use and performance, with supporting records. Also distinguish a naming change from a different legal operator. Editing the name on a local PDF and circulating it creates a mismatch with the official record.

What needs to be reviewed in a business transfer?

Article 47(1) addresses business succession following transfers or mergers; Article 47(3) addresses item-level succession by a manufacturer or importer acquiring the business for the registered device. A distribution agreement or delivery of a certificate copy alone should not be treated as equivalent.

A practical due-diligence package includes the transferred items and models, the parties' regulatory status, the contractual scope and effective time, current registration attachments, changes and renewals, manufacturer agreements, and handover of quality, complaint and recall records. Pending administrative action and Article 48's succession of sanction effects also need review. These are transaction checks, not a replacement for the statutory attachment list for a particular application.

Send the current certificates, actual product specification and proposed change or transfer scope through our free pre-review. We can help distinguish whether reissue, a registration change or succession should be examined first.

Official sources checked 28 September 2026: Medical Devices Act, Articles 6, 12, 15, 47, 48 and 49, Act 21263, effective 1 July 2026; Enforcement Rule, Article 63, Ordinance 2127, effective 1 July 2026; Government24 reissue guidance for repair, sales and rental business certificates. The operational lists are distinct from application-specific legal requirements.