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South Korea, MFDS - Medical Device Change Management


I have had some guidance translated for medical device change management in South Korea. The document is not very clear in places, so I was hoping to seek some clarification on the following questions;

1. Who is responsible for reporting minor changes? Is it the manufacturer or the local authorised representative?
2. If you need to update the existing license due to a significant change, how long does this take?
3. What information needs to be included in the technical documentation review if the change affects the safety and effectiveness of the device?

Any help/advice would be gratefully received.
Here's the application form from the website (EDIT: Regulations List | Minisry of Food and Drug Safety). You can probably get some answers for from that. As far as timing is concerned, when we changed our company name last year, it took less than two weeks from the time our distributor/customer (i.e. local representative) submitted their applications. Naturally, substantive changes should take longer and have more rigorous supporting documentation. The settlement period from submission of a full and complete application is 60 days if a clinical review is required or 42 days if only a technical documentation review is required.

For the technical documentation review, please see the other attachment, but the documents include:

4. Information on test specifications, rationale for applying such test specifications, and actual measured data for verification of performance and safety. For tests specifications unavailable domestically or internationally, the applicant shall provide his or her own specifications, rationale for applying such specifications, and actual measured data for verification of performance and safety of the device
A. Information on electrical or mechanical safety
B. Information on biological safety
C. Information on radiological safety
D. Information on electromagnetic safety
E. Information on performance
F. Information on physico-chemical property
G. Information on stability

This is Article 9, paragraph 2, subparagraph 4, cross referred from Article 5, paragraph 1, subparagraph 2, (both of the Enforcement Regulations of Medical Devices Act, attached), which is referenced in the application form.

Note: this is not from my experience except as specifically mentioned, just desk research.

EDIT: added some more edits after taking a short trip down this well-organized rabbit hole


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you may also take a look in the "Regulation on Medical Device Approval/Report/Review, Etc.", Article 19, which is available in English on the webiste of MFDS. Also important in this regard is the "Medical Devices Act Enforcement Regulation", Article 26, which is also available in English.

I guess the importer (Korea License Holder) as mentioned in the regualtions is responsible for reporting any reportable changes in the certificate/medical device.

Best regards
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