How Does the Korean MFDS Guidance on Clinical Trials for Machine Learning Medical Devices Affect Companies?

Answer: The Korean Ministry of Food and Drug Safety (MFDS) guidance on clinical trials for machine learning medical devices means that, for Korean registration, regulatory scrutiny will shift from whether artificial intelligence is used to algorithm output risk, training and validation data, clinical trial design, performance metrics, intended population, bias control, version iteration, and post-market surveillance. Companies planning to enter the Korean market should establish an algorithm evidence package and a clinical evaluation strategy in advance, and clearly define the model's intended boundaries, data sources, validation methods, and change management pathway.

Published: 2026-07-08 09:00

Updated: 2026-07-08 09:00

This FAQ addresses priority questions that companies need to assess in actual projects involving international medical device registration, documentation preparation, compliance pathways, and post-market maintenance.

Content Structure

• Key Summary
• Reference Basis
• Who Should Read This
• Regulatory Assessment Logic
• Documentation Preparation Priorities
• Operational Steps for Companies
• Common Mistakes
• Aimeili Professional Recommendations
• Internal Checklist
• Continue Reading
• Applicability Boundaries

Key Summary

The MFDS has published guidance related to clinical trials for machine learning medical devices. It indicates that when artificial intelligence and machine learning medical devices are registered in Korea, regulatory focus will shift from whether artificial intelligence is used to algorithm output risk, training and validation data, clinical trial design, performance metrics, intended population, bias control, version iteration, and post-market surveillance. Companies planning to enter the Korean market should establish an algorithm evidence package and a clinical evaluation strategy in advance, and should define the model's intended boundaries, data sources, validation methods, and change management pathway.

Reference Basis

Official source: MFDS

Source link: https://www.mfds.go.kr/eng/brd/m_40/list.do

This article is prepared based on official public information and Aimeili international registration project experience. The specific pathway should still be determined according to product risk class, intended use, and the latest requirements of the regulatory authority.

Who Should Read This

This content is suitable for medical device manufacturers, regulatory affairs professionals, overseas market leads, and CRO teams that are preparing projects related to software and artificial intelligence medical devices. If a company already has materials for China, the European Union, the United States, or other markets but is not sure whether they can be reused in a target market, it should also read this article before project initiation and complete a gap assessment.

Regulatory Assessment Logic

Companies should first confirm the product's regulatory attributes, risk class, intended use, applicable regulatory pathway, and local responsible entity, and then determine the required depth of documentation. MFDS-related requirements usually do not examine a single document in isolation. They also assess whether product claims, technical evidence, labels and instructions for use, quality system, and post-market responsibilities are consistent.

Documentation Preparation Priorities

It is advisable to build a documentation package around product description, model and specifications, risk management, performance verification, clinical or evaluation evidence, quality system, labels and instructions for use, authorization documents, UDI or traceability information, change management, and post-market surveillance. For software, artificial intelligence, IVD, sterile, active, and medium- to high-risk products, additional specialized evidence should also be provided.

Operational Steps for Companies

• First: Establish a product and model list.
• Second: Reclassify according to the target market.
• Third: Verify the coverage of existing certificates and test reports.
• Fourth: Identify labeling, language, local representative, and post-market obligations.
• Fifth: Create a gap list and a supplementary documentation plan.
• Sixth: Then arrange translation, signing, submission, and responses to review questions.

Common Mistakes

Common mistakes include directly translating domestic materials, ignoring the local responsible entity, over-relying on existing CE or FDA materials, unclear coverage of product models, label claims that exceed the evidence scope, and missing post-market surveillance and change processes. What regulators really focus on is whether the evidence chain is closed, not the number of documents.

Aimeili Professional Recommendations

Aimeili recommends incorporating this issue into the registration project initiation assessment, rather than waiting until submission to supplement documents. A more reliable approach is to first complete pathway determination and documentation gap assessment, and then manage the target country, product classification, document reuse, additional testing, local representative, and post-market maintenance in a single project plan.

Internal Checklist

• Are the product classification, intended use, and model scope clear?
• Do existing certificates, test reports, and technical files cover the registration scope?
• Are the responsibilities of the local representative, sponsor, or registration holder clear?
• Have labels and instructions for use, UDI, language, and post-market maintenance been planned?
• Has a documentation gap list and supplementary testing plan been created?
• Have official sources and applicability boundary statements been retained?

Continue Reading

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Next: How will the UK MHRA medical device regulation amendment draft affect Chinese companies?

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Content Review and Applicability Boundaries

Content author: Aimeili Regulatory Editorial Team

Professional review: Aimeili Medical Device International Registration Project Team

Source principles: Prioritize official regulatory agencies, international organizations, standards organizations, and public regulatory materials; industry media and project experience are used only as supporting judgment.

Applicability boundaries: This article is intended for preliminary understanding, documentation preparation, and project planning. It does not replace the formal requirements of target-country regulatory authorities, testing conclusions, or legal advice.