The Korea Ministry of Food and Drug Safety (MFDS) said Tuesday that it temporarily suspended the sales of 62 medical products imported by Medtronic Korea and entered into a procedure for administrative order such as cancellation.

The ministry confirmed some of the fabricated content in the document submitted by Medtronic while reviewing suitability for good manufacturing practice (GMP) of the imported medical device manufacturer.

The Ministry of Food and Drug Safety is moving to cancel the approval and good manufacturing practice of eight products and temporarily suspend the sales of 62 others imported by Medtronic Korea. (MFDS)

Medical device importer must secure GMP of the manufacturer and receive the routine inspection, according to the Medical Devices Act Article 15.

However, the company was found to have manipulated some of the documents, such as submitting a false signature after writing the device master record (DMR) of the medical device manufacturer or changing the management number and revision date of the past documents.

The ministry began the procedure to cancel approval and GMP certificate of eight items, including general-purpose electrosurgical diathermy, while temporarily suspended the sales of 62 products such as sutures, staples, and electrodes for an electrosurgical unit.

“In this case, the importer, not overseas manufacturer, directly prepared or modified some of the documents before submitting them to shorten the required period,” the ministry said. "After comparing and reviewing the manufacturer's data, we believe the document forgery has not significantly affected the quality of the products."

The ministry added that it would take necessary steps through an overall quality examination for products that won approval or received a GMP certificate based on the manipulated documents.

In response to the ministry’s step, Medtronic Korea said, "This case is thought to be caused by poor business handling on our part in the documentation that must be submitted for domestic GMP certification and renewal.”

Medtronic vowed to come up with ways to prevent the same problem from happening again in the future, in managing and supervising documentation for domestic GMP.

The ministry plans to revise the Medical Device Act to strengthen the punishment of companies violating the regulation by, for instance, imposing punitive fines on firms that gain economic benefit after obtaining permits with fabricated papers.

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