New South Korea regulations released to promote commercialization of innovative devices and strengthen competitiveness of the healthcare industry
April 30, 2019

The Ministry of Food and Drug Safety (MFDS), formerly known as the Korea Food and Drug Administration (KFDA), has recently issued the In Vitro Diagnostic Medical Devices Act (IVD act), together with the Medical Devices Industry Development and Innovative Medical Devices Support Act (Medical Devices Industry Act) and few more relevant guidelines to keep fostering and supporting the Medical Device industry.

Following on MFDS last December notifications on updated labeling requirements and implementation and management of Unique Device Identifier (UDI) regulations for Medical Devices (MFDS Notification No. 2018-110: Provision on Labeling Requirements for Medical Devices and MFDS Notification No. 2018-109: Establishment of Provision on Labeling and Management of UDI for Medical Devices, respectively), and subsequent guidelines published on this topic (Guideline: 0919-01: Guideline on UDI Generation and Guideline: 0920-01: Guideline on IDU Placement). The Korean Authorities have recently reviewed the Korea Good Manufacturing Practice (KGMP) on Medical Devices (MFDS Notification No. 2019-25) to harmonize with the latest changes implemented by international standard ISO13485:2016, which will be applicable and mandatory for Medical Devices to be circulated or sold in Korea from July 1st, 2019 as well.

Furthermore, a revision of the Provision on License, Declaration and Review of Medical Devices (MFDS Notification No. 2019-13) was introduced in order to adapt the approval procedure to In-Vitro Diagnostic Medical Devices characteristics, while adding significant changes to streamline the process. The Provision on Management of Safety Information Including Adverse Events of Medical Devices (MFDS Notification No.2019-231) was also updated and a new guideline (Guide-0943-01: Guideline on Medical Devices Recall Report) providing information on the procedures and methods of reporting Medical Device recalls was published. New examples of advertisements violating the Medical Devices Act have been added to new version of the Handbook on Advertising Violating Medical Device Act.

Also, and in line with the proposed enhancements of the regulatory landscape, the recently issued Medical Devices Industry Act establishes the requirements to be met by innovative Medical Devices companies, including an innovative Medical Device designation, required licenses and approvals, review processes, inspections and post-marketing requirements, among others. Software designated as innovative Medical Device is also considered.

In case of the IVD act, and as previously addressed by the Authorities, it is intended to consolidate a separate safety management system according to IVD Medical Devices specificities and needs. It regulates the requirements for developing, handling, management and support of both manufacturing and importing activities for IVD Medical Devices to encourage the development of innovative, effective and safe products.

Both the Medical Devices Industry Act and the IVD act will enter into force May 5th, 2020; please contact our team for more details on how Magellan could help you being abreast of all asean regulatory updates!