On February 28, 2025, the Enforcement Rule of the Digital Medical Products Act was established to define the delegated matters and necessary implementation details following the enactment of the Digital Medical Products Act (effective January 24, 2025) and its Enforcement Decree (effective January 24, 2025).
The key provisions of the Enforcement Rule include:
1) Specific criteria for the classification and grading of digital medical products
- Digital medical devices are classified based on their intended use and potential risk to the human body when used. They are categorized by product or product group and designated into four risk classes, ranging from Class 1 to Class 4, according to the required level of safety management.
2) Required documents for licensing digital medical device manufacturing and importation, as well as for approval, certification, and notification
- Business license: The application must include documents verifying the qualifications and employment status of the quality manager, as well as proof of compliance with facility standards
- Manufacturing/Import approval and certification: The application must include evidence of compliance with manufacturing and quality management system standards, as well as relevant clinical trial data.
- Manufacturing/Import notification: A notification form must be submitted without any additional supporting documents.
3) Procedures and methods for approval of clinical trial plans and clinical performance study plans for digital medical devices
- Establishes the approval procedures for clinical trial plans and clinical performance study plans for digital medical devices, as well as exemption from approval.
- Defines regulations on conducting trials outside designated clinical trial institutions and clinical performance study institutions.
- Specifies the standards for conducting and managing clinical trials and clinical performance studies for digital medical devices.
4) Procedures for real-world performance evaluation of digital medical devices, certification of excellence in management systems, and conformity assessment of quality management standards for digital medical device software
- Establishes the criteria for selecting subjects and the method for drafting evaluation plans to assess the safety and effectiveness of digital medical devices actual use by manufacturers and importers.
- Defines the application and cancellation procedures for the certification of excellence in digital medical device management systems.
- Specifies the application and evaluation procedures for conformity assessment and revised conformity assessment of digital medical device software quality management standards.
Due to the enforcement of the Digital Medical Products Act (effective January 24, 2025), digital medical devices are required to follow the business licensing and product approval/certification/notification procedures as outlined in the Act.
Please refer to the attached document below.
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