Hello, this is JNPMEDI.
The rapid advancement of digital technologies is transforming the paradigm of the healthcare industry. However, existing regulatory frameworks have not sufficiently addressed the unique characteristics of medical devices integrated with digital technologies. To overcome these limitations, South Korea has enacted the world’s first 「Digital Medical Products Act」 which will come into effect on January 24, 2025.
This legislation aims to bring regulatory innovation across the entire cycle of digital medical devices, including manufacturing, quality management, clinical trials, approval and review processes, and security systems.
Let’s take a closer look at its key elements.
Changes in Manufacturing and Quality Management Standards (GMP)
The Digital Medical Products Act transforms the traditionally hardware-centric GMP standards by integrating the unique characteristics of digital technologies.
- Introduction of Standards for Software and AI/ML
New quality management criteria have been added for digital technologies, including software design, bug fixes, and management of training data. Specific provisions for products utilizing AI/ML technologies now cover the management and evaluation of training data, enabling more precise and rigorous assessments.
- Implementation of Remote Inspections
Previously, all inspections were conducted on-site, however, under the new law, remote inspections can now be requested, significantly simplifying inspection procedures and enhancing accessibility.
- Strengthening Security Systems
Robust security management systems have been introduced to prevent electronic breaches such as DDoS attacks, data leaks, and hacking. These measures ensure improved safety and reliability for digital medical devices.
Clinical Trial Regulations for Digital Medical Device
The clinical trial regulations for digital medical devices have been improved to reflect their technical characteristics and incorporate new research methods utilizing data.
- Expansion of Clinical Trial Subjects and Formats
Previously, clinical trials were primarily focused on human subjects and specimens. However, data-driven clinical trials and decentralized clinical trials are now permitted. This innovative change allows trials to be conducted at locations outside of traditional institutions or based solely on data-driven research.
2. Transition in Approval Methods
The approval process has shifted from the previous ‘Positive’ system, where all mandatory requirements had to be met for approval, to a ‘Negative’ system, where approval is granted as long as there are no grounds for rejection. This change makes the approval process more flexible and streamlined.
3. Classification of Clinical Trial Types
Clinical trials are now categorized into exploratory trials, confirmatory trials, and post-market trials, with clear standards and requirements tailored to each purpose. Notably, post-market trials can be conducted using various methods, such as real-world evaluations or literature reviews.
Guidelines for Security Against Electronic Breaches
Medical devices integrated with digital technologies can be vulnerable to security issues such as data breaches and hacking. To address this, the following security guidelines have been newly introduced:
- Establishment of management systems to prevent electronic breaches.
- Mandatory compliance with security policies to prevent data breaches and hacking.
- Development and implementation of measures to address vulnerabilities.
These guidelines are essential for ensuring that digital medical devices can be used safely and reliably.
Certification Standards for Excellence in Management Systems
To ensure the quality of digital medical devices, the certification standards for excellence in management systems that evaluates R&D capabilities and quality management system have been strengthened.
- R&D Capabilities: Recruiting experts, operating independent departments, and establishing research and quality systems.
- Risk Management Systems: Setting risk tolerance criteria and implementing systematic management plans.
- Software Development Capabilities: Incorporating quality and project management for AI/ML-based software.
Approval and Review Regulations
A new system that enhances approval efficiency and reflects digital medical devices' characteristics has been introduced
Product Code Classification System
Product codes are generated based on usage purpose, technology type, and product form. This system has been expanded from the existing hardware-focused codes to include digital devices and software products.
Simplified Approval Procedures for Converged Products
For digital-converged pharmaceuticals, submitting a pre-approved change management plan allows approval procedures to be replaced with a simple change report. This process focuses on enhancing personalized healthcare support and ensuring safety in use.
Streamlined Review Procedures:
Criteria for representative products have been strengthened, considering factors such as AI/ML integration and production records. Remote on-site inspections are now available when necessary, enabling more efficient reviews.
The Digital Medical Products Act revolutionizes regulatory frameworks in healthcare, fostering a patient-centered medical environment through the integration of digital technology and healthcare. This law enhances the quality and safety of medical devices while accelerating development, and strengthening global market competitiveness with simplified approval process.
For further information or consultations regarding digital medical devices, please contact JNPMEDI. JNPMEDI is ready to support the successful integration of your medical device products into the new regulatory framework.
More valuable updates will be shared in the future.
Thank you!
Hello, this is JNPMEDI.
The rapid advancement of digital technologies is transforming the paradigm of the healthcare industry. However, existing regulatory frameworks have not sufficiently addressed the unique characteristics of medical devices integrated with digital technologies. To overcome these limitations, South Korea has enacted the world’s first 「Digital Medical Products Act」 which will come into effect on January 24, 2025.
This legislation aims to bring regulatory innovation across the entire cycle of digital medical devices, including manufacturing, quality management, clinical trials, approval and review processes, and security systems.
Let’s take a closer look at its key elements.
Changes in Manufacturing and Quality Management Standards (GMP)
The Digital Medical Products Act transforms the traditionally hardware-centric GMP standards by integrating the unique characteristics of digital technologies.
New quality management criteria have been added for digital technologies, including software design, bug fixes, and management of training data. Specific provisions for products utilizing AI/ML technologies now cover the management and evaluation of training data, enabling more precise and rigorous assessments.
Previously, all inspections were conducted on-site, however, under the new law, remote inspections can now be requested, significantly simplifying inspection procedures and enhancing accessibility.
Robust security management systems have been introduced to prevent electronic breaches such as DDoS attacks, data leaks, and hacking. These measures ensure improved safety and reliability for digital medical devices.
Clinical Trial Regulations for Digital Medical Device
The clinical trial regulations for digital medical devices have been improved to reflect their technical characteristics and incorporate new research methods utilizing data.
Previously, clinical trials were primarily focused on human subjects and specimens. However, data-driven clinical trials and decentralized clinical trials are now permitted. This innovative change allows trials to be conducted at locations outside of traditional institutions or based solely on data-driven research.
2. Transition in Approval Methods
The approval process has shifted from the previous ‘Positive’ system, where all mandatory requirements had to be met for approval, to a ‘Negative’ system, where approval is granted as long as there are no grounds for rejection. This change makes the approval process more flexible and streamlined.
3. Classification of Clinical Trial Types
Clinical trials are now categorized into exploratory trials, confirmatory trials, and post-market trials, with clear standards and requirements tailored to each purpose. Notably, post-market trials can be conducted using various methods, such as real-world evaluations or literature reviews.
Guidelines for Security Against Electronic Breaches
Medical devices integrated with digital technologies can be vulnerable to security issues such as data breaches and hacking. To address this, the following security guidelines have been newly introduced:
These guidelines are essential for ensuring that digital medical devices can be used safely and reliably.
Certification Standards for Excellence in Management Systems
To ensure the quality of digital medical devices, the certification standards for excellence in management systems that evaluates R&D capabilities and quality management system have been strengthened.
Approval and Review Regulations
A new system that enhances approval efficiency and reflects digital medical devices' characteristics has been introduced
Product Code Classification System
Product codes are generated based on usage purpose, technology type, and product form. This system has been expanded from the existing hardware-focused codes to include digital devices and software products.
Simplified Approval Procedures for Converged Products
For digital-converged pharmaceuticals, submitting a pre-approved change management plan allows approval procedures to be replaced with a simple change report. This process focuses on enhancing personalized healthcare support and ensuring safety in use.
Streamlined Review Procedures:
Criteria for representative products have been strengthened, considering factors such as AI/ML integration and production records. Remote on-site inspections are now available when necessary, enabling more efficient reviews.
The Digital Medical Products Act revolutionizes regulatory frameworks in healthcare, fostering a patient-centered medical environment through the integration of digital technology and healthcare. This law enhances the quality and safety of medical devices while accelerating development, and strengthening global market competitiveness with simplified approval process.
For further information or consultations regarding digital medical devices, please contact JNPMEDI. JNPMEDI is ready to support the successful integration of your medical device products into the new regulatory framework.
More valuable updates will be shared in the future.
Thank you!