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With the Digital Medical Products Act established in January 2024 set to take effect in January 2025, the Ministry of Food and Drug Safety (MFDS) has issued a legislative notice for its sub-statues, namely the enforcement decree and enforcement rules. The requirements newly established outside the scope of the existing laws (Medical Devices Act, In-Vitro Diagnostic Medical Devices Act, Pharmacists Act) are summarized below. For reference, the Digital Medical Products Act distinguishes products into digital medical devices, digital combination pharmaceuticals, and digital medical/health support devices, requiring separate licensing and post-management for each product type.
- Digital Medical Devices
- Scope of Application: Products that were classified as medical devices or in-vitro diagnostic medical devices under existing laws (Medical Devices Act and In-Vitro Diagnostic Medical Devices Act) and utilize technologies such as AI/robotics/supercomputing/healthcare information for “prognosis, prediction, monitoring, and rehabilitation” of diseases, etc.
- Classification: Divided into four classifications based on intended use, potential risk, medical context or patient condition, impact on healthcare, harm caused by performance degradation/malfunctions, and functional characteristics, etc.
- New Manufacturing and Import Permits: In addition to the existing requirements under the Medical Devices Act and In-Vitro Diagnostic Medical Devices Act, a separate permit for the manufacturing and import of digital medical devices is required in advance. Separate facilities (workshops, laboratories, storage facilities, etc.) and personnel (quality manager) standards must be met to receive these permits.
- New Approval Procedures for Products: Pre-approval is required in accordance with approval (Class 4/3), certification (Class 2), or notification (Class 1) procedures.
- Required Submission Materials for Approval: In addition to materials required under existing laws, materials such as "evaluation data (including clinical trials, etc.), protective measures against electronic breaches, usability data, etc." must be submitted.
- Exemption from Approval: Digital medical devices used in certified clinical laboratories (CLIA), electronic medical record systems used by healthcare professionals, and software that transmits medical data (excluding images) within hospitals.
- KGMP Certification Requirement: New quality management standards for digital medical device software. Other products adhere to existing quality management standards (ISO 13485:2016).
- Exemption from Pre-Approval of Clinical Trial Protocols: Digital medical devices with low risk, such as data-driven clinical and non-contact devices, and those exempt from licensing are designated for exemption.
- Waiver of Consent for Clinical Trials Using Medical Data: When IRB approval is obtained, medical data that cannot be anonymized or for which written consent cannot be obtained may be used clinically.
- Change Approval Procedures: Changes that do not affect safety and efficacy may be self-managed and reported to the MFDS. In the case of digital medical devices with AI technology, and a change management plan was submitted at the time of product approval, these changes are exempt from approval.
- Compliance Requirements for Manufacturers/Importers: In addition to compliance required under existing laws, information collected by digital medical devices must be legally collected and managed in accordance with Personal Information Protection Act and Medical Service Act. Digital medical device software designated for professional use cannot be sold directly to individuals.
- Real World Evaluation of Approved Products: If used within the approved scope or the change management plan was submitted at the time of approval, post-market information generated during actual use can be collected and evaluated. This information may also be submitted during change approval. Additionally, if a real world evaluation plan is submitted, such product can be provided free of charge to medical institutions despite the prohibition of providing economic benefits.
- Introduction of Excellent Management System Certification: Companies with excellent management system certification may be exempt from submitting some materials during product approval and are recognized as having passed the quality management standards for digital medical device software.
- Documentation Requirements: For digital medical device software, information must be provided electronically, differing from existing laws.
- Advertising: If a digital medical device software is designated as for professional use, advertising may only be conducted via specialized media directed at professionals, etc., and pre-approval for advertising is waived. Additionally, such designation can be notified to the Ministry of Health and Welfare and Health Insurance Review & Assessment Services, which are administrative agencies responsible for insurance registration, to be considered for reimbursement listing.
- Digital Combination Pharmaceuticals
- Scope of Application: Refers to pharmaceuticals that combine digital medical devices or digital medical/health support devices with pharmaceuticals (including biologics).
- New Manufacturing and Import Permits: Separate from the manufacturing and import permits required under existing Pharmacists Act and Biopharmaceutical Act, permits for digital combination pharmaceuticals must be obtained in advance. Separate facilities (workshops, laboratories, storage facilities, etc.) and personnel (manufacturing manager and safety manager) standards must be met.
- Reporting for Contract Manufacturing and Distribution Business: Contract manufacturing of digital combination pharmaceuticals domestically requires prior reporting of contract manufacturing and distribution business.
- Product Approval and QMS Certification: Introduction of linkage system of product approval and QMS certification similar to the drug approval-patent linkage system.
- Registration of Overseas Manufacturers: Summary information on personnel, facilities, manufacturing, and quality control regarding overseas manufacturers must be registered in advance.
- Digital Medical/Health Support Devices (Effective from January 2026)
- Scope of Application: Products that do not fall under digital medical devices but monitor/measure/collect and analyze biometric signals or provide health management information, such as diet/exercise, etc., by recording or analyzing lifestyle habits for the purpose of medical support or maintenance/improvement of health.
- Reporting Procedures Established: Requires reporting of product name, manufacturer information, and product manual (intended use and performance).
- Performance Certification: Manufacturers and importers can apply for performance certification from MFDS for reported products. The MFDS will evaluate compliance with performance certification criteria and grant certification. Additionally, products that receive performance certification may use the performance certification mark on the product.
- Collection Inspections: The MFDS may conduct performance checks on digital medical/health support devices in circulation via collection inspections and based on the inspection results regulate false/exaggerated advertising and labeling or order recall/disposal and cessation of sales. Related facts will also be publicized on the MFDS homepage.
- Common Matters
- Performance Evaluation of Components: Performance evaluations can be requested for components of digital medical products (e.g., software APIs), and the component that has completed performance evaluation may be exempt from providing certain materials when applying for the approval/certification/notification of the digital medical product.
In addition to the above information, it seems necessary to keep an eye on administrative rules that will be enacted in the near future. MDREX, as a consulting firm specializing in the medical device field, quickly understands domestic medical device-related regulations and supports compliance with relevant laws for its customers manufacturing and importing medical devices. If you need assistance regarding medical device regulation or Korean market entry, please feel free to contact MDREX at pro@mdrex.co.kr.
Thank you
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