South Korea Introduces Revised Regulations on In Vitro Diagnostic Medical Device Manufacturing and Quality Control

Seoul, South Korea - The Ministry of Food and Drug Safety has announced the partial revision of the "Standards for Manufacturing and Quality Control of In Vitro Diagnostic Medical Devices" (Ministry of Food and Drug Safety Notice No. 2021-31, issued on April 7, 2021). The purpose of this announcement is to inform the public in advance and gather opinions on the intention, reasons for revision, and key contents of the proposed amendments, in accordance with Article 46 of the Administrative Procedure Act.

On May 30, 2023, the Ministry of Food and Drug Safety released a draft of the partial revision notice for the "Standards for Manufacturing and Quality Control of In Vitro Diagnostic Medical Devices." The following are the main reasons for the revision and its key points:

Reason for Revision

• The revision aims to establish a more efficient review system by simplifying the submission of similar documents and consolidating review authorities, in order to promote substantial quality control of in vitro diagnostic medical devices.

Key Contents

• Change of Review Authority: The authority responsible for quality control reviews will be transferred from regional offices of the Ministry of Food and Drug Safety to the quality management review agency. Joint on-site inspections for Grade 3 and Grade 4 facilities will be conducted. However, document reviews will be performed solely by the quality management review agency, and for export-oriented medical devices of Grade 3 and Grade 4, the quality management review agency will handle the reviews independently.
  

• Rationalization of Document Reviews: Similar documents submitted for document reviews will be consolidated and substantial review materials will be submitted to ensure the reliability of Good Manufacturing Practice (GMP) compliance recognition.

• Clarification of Review Procedures for Compliance Recognition of Manufacturing and Quality Control Standards: The revised amendment stipulates that if the submitted documents meet all requirements without any deficiencies, they will be accepted within five days of submission.

• Exemption of Location Change Evaluation: In vitro diagnostic software manufacturers will be exempted from the obligation to have facilities (workplaces, storage areas, testing laboratories, etc.) for manufacturing. If the location of an in vitro diagnostic software manufacturer changes, it will be excluded from the scope of "change evaluation."

• Improvement of GMP Evaluation Submission Documents: In vitro diagnostic software manufacturers will only need to include information about workplaces, testing laboratories, and storage areas in the submitted evaluation application documents if they have such facilities.

The Ministry of Food and Drug Safety is inviting organizations or individuals with opinions regarding the proposed partial revision of the "Standards for Manufacturing and Quality Control of In Vitro Diagnostic Medical Devices" to submit their feedback by July 31, 2023. The opinions should be sent to the following address:

The revised amendment to the "Standards for Manufacturing and Quality Control of In Vitro Diagnostic Medical Devices" will come into effect on the date of its announcement, with the exception of the revised provisions in Article 7, which will take effect three months after the announcement.

MORE INFO AND DOCUMENTS AVAILABLE AT HERE.