South Korea Updates Medical Device Good Manufacturing Practice

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


On October 22, 2025, South Korea’s Ministry of Food and Drug Safety (MFDS) announced an administrative notice on a partial amendment to the Medical Device Good Manufacturing Practice (GMP). The amendment aims to enhance the rationality and efficiency of the medical device conformity assessment system by introducing a basis for expedited review of life-supporting devices, removing duplicate evaluations in contract manufacturing, and clarifying the scope of on-site inspections.


Key Details of the Amendment

  • Establishment of Expedited Review Procedures

A framework will allow expedited review of medical devices essential for life support, surgery, or emergency care, as well as newly developed or innovative devices. This is intended to minimize commercialization delays and improve patient access when rapid market supply is needed due to manufacturing or import suspension.

  • Streamlining Review Procedures Between Contracting Parties

If a manufacturer already holds a valid conformity certificate for the same product group at the same manufacturing site, duplicate conformity assessments will be exempted regardless of the contracting party. This reduces administrative burden and improves efficiency in review resource utilization.

  • Clarification of On-Site Inspection Scope

The amendment clearly defines the scope and subjects of on-site inspections to prevent misunderstanding and ensure consistent and fair assessments.

  • Specification of Certificate Validity Period in Combined Reviews

In combined reviews, the validity period of the conformity certificate will be set to a maximum of three years, consistent with MDSAP certificates, to ensure administrative alignment.


Organizations or individuals wishing to comment on the amendment may submit their opinions 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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