'Document Manipulation' Medtronic Korea Suspends Sales of 62 Items

MFDS: "Importer Document Forgery... Likely No Impact on Quality"

[Asia Economy Reporter Cho Hyun-ui] The Ministry of Food and Drug Safety announced on the 4th that it will temporarily suspend the sales of 62 items, including general medical clips and sutures, imported by Medtronic Korea (hereinafter Medtronic).

The Ministry made this decision after discovering some falsified documents while reviewing the documents submitted by Medtronic for the recognition of manufacturing and quality control compliance of the imported medical device manufacturing site.

Accordingly, sales of 62 items, including sutures and internal staples, will be suspended, and administrative actions such as license cancellations will be initiated for 8 products, including general-purpose electrosurgical devices.

It was revealed that Medtronic submitted forged signatures of the medical device manufacturing site personnel on some documents or altered the management numbers and revision dates of previously submitted documents.

In response, the Ministry of Food and Drug Safety has begun procedures to cancel the approvals and the Good Manufacturing Practice (GMP) compliance certificates obtained through document manipulation, and has ordered a temporary sales suspension to protect consumers.

However, since this incident involved the medical device importer manipulating manufacturing site documents to shorten the document preparation period, it is judged that the quality of the products is unlikely to be significantly affected.

The Ministry stated, "To strengthen medical device safety management, we plan to revise laws to impose punitive fines on companies that obtain approvals through document manipulation and to require submission of GMP compliance certificates from the manufacturing country to ensure thorough medical device review," and announced measures to prevent recurrence.

This content was produced with the assistance of AI translation services.