{"id":3500,"date":"2017-07-25T10:37:10","date_gmt":"2017-07-25T08:37:10","guid":{"rendered":"http:\/\/www.thema-med.com\/?page_id=3500\/"},"modified":"2023-10-06T09:54:52","modified_gmt":"2023-10-06T07:54:52","slug":"medical-device-registration-south-korea","status":"publish","type":"page","link":"https:\/\/www.thema-med.com\/en\/medical-device-registration-south-korea\/","title":{"rendered":"Medical Device Registration in South Korea"},"content":{"rendered":"
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Regulatory Authority<\/b><\/h5>\n

Ministry of Food and Drug Safety (MFDS)<\/p>\n

Classification<\/strong><\/h5>\n

I, II, III, IV<\/p>\n

Quality system<\/b><\/h5>\n

Quality System compliance to the Korea Good Manufacturing Practice requirements (partly harmonized with the ISO 13485:2016: 2003 requirements).<\/p>\n

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<\/i><\/span>The information on this page is valid and current as of December 2017. The legislative and regulatory provisions are subject to changes and updates by the Regulatory Authorities of the State to which they refer. Considering the above, the writer declines all responsibility regarding any non-actuality and\/or inaccuracy of the information received concurrently with or following the publication of this page Disclaimer<\/a><\/strong><\/em><\/span><\/div><\/div><\/div><\/div>

Medical Devices are subject to registration.
Foreign manufacturers shall appoint an Authorized Local Representative (Korea License Holder-KLH) who will be responsible for post-market surveillance.<\/p>\n

As regards Class I devices, the pre-market notification must be sent online to the Competent Authority and it is not mandatory to possess the KGMP certificate.<\/p>\n

As regards Class II, III and IV devices it is necessary to submit a registration application and in order to be granted with the license it is essential to obtain the KGMP Certificate following the KGMP Audit.<\/p>\n

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Applicant<\/span><\/h3>\n

Korea License Holder (KLH).<\/p>\n

Timeframe and fees<\/span><\/h3>\n

Class I: 1 month
Class II: 4-6 months
Class III: 6-10 months
Class IV: 6-10 months<\/p>\n

Validity<\/span><\/h3>\n

Issued notification and registrations do not have any validity limits. The KGMP Certificate is valid for 3 years.<\/p>\n

Labelling and documentation language<\/span><\/h3>\n

Documentation and labelling must be provided in Korean.<\/p>\n

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    Do you want to market your Medical Device in this Country? Contact us!\n<\/h3>\n