South Korea Proposes Amendment to Medical Device Production Reporting Regulation

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This notification takes effect on the date of its official announcement.


On October 22, 2025, the Ministry of Food and Drug Safety (MFDS) issued an administrative pre-announcement of the draft amendment to the Regulation on Reporting the Production, Export/Import, and Repair Performance of Medical Devices. The amendment aligns with the enforcement of the Digital Medical Products Act (effective January 24, 2025) and aims to specify reportable digital medical devices and establish new reporting forms suited to their characteristics, improving the efficiency of the reporting system.


  • Specification of digital medical devices subject to reporting and establishment of new reporting forms for digital medical devices

Reportable digital medical devices will be clearly defined, excluding standalone software. New forms will enable reporting by product code for more accurate and efficient submissions.

  • Refinement of employee reporting forms

Employee reporting forms will be standardized to ensure consistent classification across the food and drug sectors.

  • Establishment of confidentiality obligations for reported data

Agencies handling reports will be required to maintain confidentiality and prohibited from using reported information for non-official purposes, reinforcing data security.


Comments on the draft may be submitted to the MFDS by November 14, 2025.


GCA Korea provides expert support for global companies navigating South Korea’s regulatory requirements. Our specialties include KC EMC, KC Safety, KC Energy Efficiency, KC Automotive Components, KCsEx (ATEX, IECEx), or MFDS (Korean Medical Devices). For tailored certification and regulatory assistance, contact GCA Korea. We’re here to streamline your market access in South Korea.



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