Recently, a Prime Ministerial Decree was announced and implemented to partially revise five laws and regulations, including temporary deregulation, in effort to revitalize the livelihood of the citizens. As a result, the Medical Device Act Enforcement Decree was revised, and the obligation to report supply history required for all Class III and IV medical devices and some of Class I and II medical devices was significantly reduced as of July 8.

:: Supply History Report: A requirement for a medical device manufacturer/importer/seller/renter suppling medical devices to a medical institution (hospital, etc.) or a medical device seller/renter to report to the Ministry of Food and Drug Safety(MFDS) by the end of the month following the date of supply the relevant information, including details concerning the recipient, medical device code (UDI-DI/PI), type of supply (sale/rental, etc.), product information, quantity, supply price, etc.

 

[Changes concerning Targets subject to Supply History Reporting]

• Implantable medical devices (Class III, IV) – Medical devices that are inserted into the human body and maintained for more than 30 days
• Separately registered medical materials if supplied to medical institutions
• Other medical devices as designated by the MFDS Minister in consultation with the MOHW Minister

Some medical devices previously subject to supply history reporting, including some Class I and II medical devices, non-implantable Class III and IV, and medical devices not separately listed as medical materials, shall be exempt from reporting obligations starting from June, which would have been reported by July.

 

Even before this revision, MFDS has been working to promote active participation by the industry and to stabilize the system by easing administrative sanctions applied to failure to report supply history and setting the grace period until the end of this year, etc.

However, the obligations that all medical devices must comply with, such as registering integrated medical device information and labeling requirements shall remain in effect, so UDI registration and external standard code display must continue to be observed regardless of the supply history reporting obligation.

 

As a consulting firm specializing in the medical device field, MDREX quickly identifies domestic medical device-related regulations such as the above and supports medical device manufacturing and importing clients to be in compliance with the related laws. For overseas manufacturing customers, as a domestic license holder, we perform tasks such as supply history reporting, labeling, import procedures required by regulations, adverse event reporting, etc. If you require assistance with medical device regulation and market entry, please contact MDREX (pro@mdrex.co.kr) at any time.

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