The regulatory process for medical devices in South Korea requires manufacturers to determine the classification of their device and submit the appropriate registration application and supporting documentation to the Ministry of Food and Drug Safety (MFDS). For new devices without a predicate, manufacturers must submit clinical data as part of a Clinical Data Review. Class II devices considered "Special Equivalent" have an expediated review process without a Technical File requirement. Prior international testing may satisfy some requirements but additional Korea-specific testing is often necessary. The MFDS may request additional information or audit submissions, extending approval timelines.

1. The regulatory process for medical devices
KRSouth Korea
* If your device (all classes) is new or does not have a predicate in the South Korean market, then the MFDS will require a Clinical Data Review, formerly Safety and Efficacy
Review (SER). Manufacturers will be required to submit Clinical Data with their application and the registration approval timeline and fees will increase accordingly.
** There are approximately 350 Class II devices that MFDS considers “Special Equivalent,” which require a less robust application, i.e. no Technical File, as well as an expedited
review by a Third Party Reviewer.
*** Prior testing done in accordance with ISO or other international standards will satisfy some testing requirements; however, most manufacturers have to conduct additional
testing, including performance testing, to Korea specific product standards.
This is a simplified overview of the process. The MFDS may choose to audit your submission and request more documents, which will add time to your approval.
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Determine classification of your device based on the device database, regulations provided by South Korea’s Ministry of Food and Drug Safety (MFDS), as well as
predicate devices in the South Korean market. If no predicate exists, the device will follow the Clinical Data Review route.*
Class I Class II** Class III Class IV
Ifyou do not have a local office in South Korea,you must appoint a Korea License Holder based in the countryto manageyour medical device registration with the MFDS.
Prepare Pre-Market Notification
including basic device information.
Prepare registration application in
Korean, including technical file, test
reports and KGMP certificate.
Prepare registration application in Korean,
including technical file, test reports and KGMP certificate.
Class IV devices require an additional technical file in STED format.
Send your device to Korea for testing OR prepare existing equivalent Korea testing results. ***
Appoint a qualified importer/distributor to bring your device into South Korea.
You are now authorized to begin marketing your device.
KLH submits Pre-Market Notification
application to the MFDS database.
Pay application fees.
KLHsubmitsKoreanregistrationdossierto
acertifiedThirdPartyReviewer. Application
includestechnicalfile,testreports,and
KGMPCertificate. AftersuccessfulThird
PartyReview,theMFDSwillissuethefinal
approval.Payapplicationfees.
KLH submits Korean registration dossier to the MFDS for review.
Dossier includes the Technical File plus STED Technical File (Class IV),
test reports, and KGMP certificate.
Pay application fees.
Obtain Korea Good Manufacturing
Practices (KGMP) certificationthrough an
onsite audit. Class II device manufacturing
facilities are usuallyaudited byaThird
PartyAuditor. KGMPcertification must be
renewed every3years.
Obtain Korea Good Manufacturing Practices (KGMP) certification through an
onsite audit. Class III and IV device manufacturing facilities are audited by a Third
Party Auditor and the MFDS. KGMPcertification must be renewed every3years.
Class I devices do not require approval,
only Notification to the MFDS. The MFDS
will publish the device on their website.
Notifications do not expire.
Full application review conducted.
Pre-Market Approval license is issued by the MFDS and published on their website.
Registrations do not expire.

2. The regulatory process for medical devices
EmergoGroup.com/south-korea
This is a simplified overview of the process. South Korea’s Ministry of Food and Drug Safety (MFDS) may choose to audit your submission and request more documents, which
will add time to your approval.
NOTE 1: The time frames shown above are typical for the majority of medical device submissions but assume that your device does not contain animal tissue, medicinal
substances or employ entirely novel technology. Your length of approval will depend on the quality and completeness of your technical documentation and how much time you
take to address additional information requests from authorities after submission. YOUR SUBMISSION(S) MAY TAKE MORE TIME THAN WHAT IS SHOWN ABOVE.
NOTE 2: The device license does not expire, but is subject to reevaluation. Periodically the MFDS will select devices codes to reevaluate as a whole. Typically this does not apply
to products that were recently approved under that selected device code, as this process is intended to ensure older products meet the current regulatory requirements.
Manufacturers will need to submit documents for reevaluation; documents include but are not limited to: updated vigilance, updated QMS documents, updated approvals from
other markets. Announcements of device codes up for reevaluation typically happen in April or May, and manufacturers must submit before the end of the year. Failure to
comply with the reevaluation will cause the device license to be revoked.
NOTE 3: The device notification (Class I) and license (Class II-IV) does not expire, so no renewal is required.
NOTE 4: Our rating of the complexity of the registration process is based on our experience and the opinion of nearly 1,000 QA/RA professionals worldwide who were asked to
rate the difficulty of registering a device in each country. The European CE Marking process is considered the mid-point to which all other markets are compared.
NOTE 5: Low = Less than US$5000; Midpoint = US$15000-$30000: High = More than US$50000. Overall cost includes registration application fees, product testing, in-country
representation, submission preparation consulting and translation of registration documents but not IFU. Costs assume you already have approval for your device in the United
States, Europe, Canada or Japan. Does not include cost of implementing or auditing a quality management system, if applicable.
* If your device (all classes) is new or does not have a predicate in the South Korean market, then the MFDS will require a Clinical Data Review, formerly Safety and Efficacy
Review (SER). Manufacturers will be required to submit Clinical Data with their application and the registration approval timeline and fees will increase accordingly.
†† There are approximately 350 Class II devices that MFDS considers “Special Equivalent,” which require a less robust application, i.e. no Technical File, as well as an expedited
review by a Third Party Reviewer.
© 2015 Emergo – You are welcome to publish this chart on your website, or copy it for use in presentations or other materials if it is not cropped in any way. Have comments or
suggestions about the content of this chart? Email us at marketing@emergogroup.com. Chart updated 03/2015.
Device classification
in South Korea
How long you should
expect to wait after
submission until
approval is granted.
(See note 1)
Validity period for
device registrations.
(See note 2)
Registration
renewal should be
started this far in
advance.
(See note 3)
Complexity of the
registration process for
this classification.
(See note 4)
Overall cost of gaining
regulatory approval.
(See note 5)
CLASS I 1 month
Does not
expire
Not applicable
Simple Complex Low High
CLASS II*† 4-6 months
Does not
expire
Not applicable
Simple Complex Low High
CLASS III* 6-10 months
Does not
expire
Not applicable
Simple Complex Low High
CLASS IV* 6-10 months
Does not
expire
Not applicable
Simple Complex Low High
KRSouth Korea