August 13, 2026
By Sora Lee
Series on the Digital Medical Products Act
As discussed in our initial Regulatory Update, the Ministry of Food and Drug Safety (MFDS) has enforced the Digital Medical Products Act (DMPA). Now that we have over a year of experience with the DMPA, we share information related to the Digital Korea Good Manufacturing Practice (Digital K-GMP) (background, insights), identification of the appropriate product code, selection of the risk classification and, in this regulatory update, the registration process.
New registration process and transition for existing digital medical products
Existing software medical devices that were previously licensed under the Medical Device Act, and that now fall within the remit of the DMPA, may continue to be marketed under the transitional provisions. However, any post-market changes that require regulatory approval after the DMPA's implementation should be handled in accordance with the Regulations on Approval, Certification, Notification, Review, and Evaluation of Digital Medical Products.
For new digital medical product registrations, the applicable requirements under the DMPA should be followed. In addition, as we've described, compliance with the Digital K-GMP requirements — which govern the quality management system for digital medical devices — should be demonstrated as part of the registration process. Hence, digital medical products must adhere to the DMPA and Digital K-GMP, and compliance with the Medical Device Act (and K-GMP) is not required.
What documentation must be submitted for registration of a digital medical product?
The tables below compare the registration documents required for a new device subject to the DMPA with those required under the previous Medical Device Act.
Standalone digital medical device software
The documents required to register standalone software (software as a medical device, or SaMD) that is categorized as a general medical device, compared with a digital medical product, are described in the following table.
Required materials to register | ||
No. | Medical Device Act (under Regulations on Approval, Notification, and Review of Medical Devices) | Digital Medical Products Act |
| 1 | Data compared with a predicate device (Annex 3 under Regulations on Approval, Notification, and Review of Medical Devices) | Deleted |
| — | Digital Medical Device Product Code and Classification Assessment Form (new) | |
| 2 | Data regarding intended use | Data regarding intended use and operating principle |
| 3 | Data regarding operating principle | Data regarding intended use and operating principle |
| 4 | Data on test specifications, acceptance criteria and test results to verify the safety and performance of the device:
|
|
| 5 | Data regarding the origin, discovery and development history | Data regarding domestic and international status and development history
|
| 6 | Data regarding foreign use status | Data regarding domestic and international status and development history |
| 7 | Clinical trial data | Data on clinical trials and other evaluations |
| 8 | — | Data regarding professional-use digital medical device software (new) * |
| 9 | — | Change Management Plan (new)** |
* If applicable to professional-use digital medical device software.
** If applicable to digital medical devices utilizing AI technology, and changes are to be implemented in accordance with the change management plan.
Software-embedded digital medical device
The documents required to register a software-embedded digital medical device (software in a medical device, or SiMD) that is categorized as a general medical device, compared with a digital medical product, are described in the following table.
Required materials to register | ||
No. | Medical Device Act (under Regulations on Approval, Notification, and Review of Medical Devices) | Digital Medical Products Act (under Regulations on Approval, Certification, Notification, Review, and Evaluation of Digital Medical Products) |
| 1 | Data compared with a predicate device (Annex 3 under Regulations on Approval, Notification, and Review of Medical Devices) | Deleted |
| — | Digital Medical Device Product Code and Classification Assessment Form (new) | |
| 2 | Data regarding intended use | Data regarding intended use and operating principle |
| 3 | Data regarding operating principle | Data regarding intended use and operating principle |
| 4 | Data on test specifications, acceptance criteria and test results to verify the safety and performance of the device
| Software
|
Hardware Data on test specifications, acceptance criteria and test results to verify the safety and performance of the device:
| ||
| 5 | Data regarding the origin, discovery, and development history | Data regarding domestic and international status and development history |
| 6 | Data regarding foreign use status | Data regarding domestic and international status and development history |
| 7 | Clinical trial data | Data on clinical trials and other evaluations |
| 8 | — | Data regarding professional-use digital medical device software (new)* |
| 9 | — | Change Management Plan (new)** |
* If applicable to professional-use digital medical device software.
** If applicable to digital medical devices utilizing AI technology, and changes are to be implemented in accordance with the change management plan.
Concluding remarks
With the separation of software medical devices (SaMD and SiMD) as either products subject to the Medical Device Act or the DMPA, registration has become significantly more complex and challenging. The first strategic step for any digital product, therefore, is to assess whether the product is subject to the Medical Device Act or the DMPA, as the requirements between the two differ.
Emergo by UL has developed expertise in Digital K-GMP certification, identifying appropriate product codes, performing risk classification, and compiling and reviewing regulatory documents.
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