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Frequently Asked Questions
Answers to the first questions companies ask when preparing Korean medical-device registration.
These are general explanations. The actual pathway should be confirmed after reviewing intended use, product category and class, test evidence and manufacturing-site conditions.
Frequently Asked Questions
Can a device with an overseas approval be sold in Korea immediately?
No. Overseas evidence may be reusable, but Korean product authorization and applicable quality and import requirements still need separate confirmation.
Is a Korean legal entity always required?
An overseas manufacturer needs an appropriate local party to perform the Korean authorization and import roles.
Does ISO 13485 exempt a manufacturer from KGMP?
ISO 13485 evidence is important, but the Korean KGMP requirements applicable to the product and manufacturing site must still be checked.
When can timing and cost be estimated?
After product classification and an evidence-gap review, a range can reflect testing, KGMP and authority-review variables.
Must every document be ready before consultation?
No. Start with a product description and an inventory of available evidence. Mark documents that have not yet been obtained.
What product information matters at the first review?
Intended use, mechanism, model differences and components help define the initial review. Include a product description or instructions if available.
How should multiple models be organized?
Tabulate model names and differences, and identify the models covered by each report. Application grouping needs a separate assessment.
What should we agree with the overseas manufacturer?
Define evidence owners, confidentiality, response timing and product or site change notifications to reduce gaps during preparation.
What is checked first in existing test reports?
Review standard versions, tested models, conditions and their correspondence to the proposed device. Possession of a report does not establish its acceptability.
What should be separated when comparing quotations?
Distinguish consulting scope, testing and assessment costs, translation and supplementary work. Compare assumptions and exclusions as well.
MFDS medical-device regulations · MFDS medical-device approval process · Content baseline · Check current requirements for the specific product
Clarify the Korean regulatory pathway for your product.
Attach what you have and we will reply by email after reviewing it. You do not need a complete set of documents.