July 31, 2026
By Sora Lee
What is Digital K-GMP for medical devices in South Korea?
Medical devices classified as digital medical products according to the Digital Medical Products Act (DMPA) must comply with Digital Korea Good Manufacturing Practice (Digital K-GMP) requirements. These requirements involves more extensive compliance requirements than the K-GMP regulations applicable to general medical devices.
Certificates obtained under the K-GMP regulation prior to the enforcement of the DMPA are valid until the expiration date. However, renewal audits must be prepared and submitted in accordance with the Digital K-GMP regulation. For digital medical devices in South Korea, a Digital K-GMP certificate is a key prerequisite to registration. As such, Digital K-GMP certification is an essential step for market entry.
Digital K-GMP audits types and requirements
Similar to K-GMP audits, there are four types of Digital K-GMP audits: initial, change, renewal and alternative audits. Digital K-GMP uses alternative audits rather than additional K-GMP audits, with alternative audit conditions outlined below. The initial audit is the first audit for digital medical devices. Similar to K-GMP, the renewal audit must be performed every three years, and the Digital K-GMP renewal application must be submitted at least three months before expiration.
In addition, the DMPA and Digital K-GMP audit application categorize seven types of medical device audit subjects.
Types of digital medical device audit subjects
No. | Audit subjects |
1 | Standalone digital medical device software |
2 | Embedded digital medical device software |
3 | Medical device hardware |
4 | Medical device hardware + Embedded digital medical device software |
5 | Class 1 medical device hardware* |
6 | Medical device for clinical trials |
7 | Digital medical devices for export |
*Class I medical devices are exempt from Digital K-GMP audits and can be replaced by the notification process. However, manufacturers may still apply for a Digital K-GMP audit voluntarily.
K-GMP vs. Digital K-GMP audits
The main differences relate to the audit agency, the applicable regulations, audit method and additional technical requirements.
| K-GMP | Digital K-GMP |
Audit agency | Third-party audit agency (TPA) and Ministry of Food and Drug Safety (MFDS) | National Institute of Medical Device Safety Information (NIDS) |
Regulation (audit scope)* | Annex 2 – Criteria for Conformity Assessment and Audit | Annex 2 – Criteria for Conformity Assessment and Audit (Applying for medical device H/W and S/W with and without AI/ML function) |
Annex 3 – Audit Criteria for Digital Medical Device Software (Applying for medical device software) | ||
Annex 4 – Audit Criteria for AI Control Measures in Digital Medical Devices (Applying for medical device with AI/ML function) | ||
| Security Guidelines for Electronic Infringement on Digital Medical Devices | ||
Audit Method | On-site audit and desktop audit, depending on the audit type | On-site audit and desktop audit, depending on the audit type |
| Remote audit (if the facility conditions designated by NIDS are satisfied in order to conduct a remote audit) | ||
Basis of Audit | Product-group based | Type-group based* |
Additional Requirements | N/A | AI/ML life cycle management, cybersecurity, software maintenance |
* Digital medical device S/W (software): AI/ML function, without artificial intelligence (AI)/machine learning (ML) function
* Medical device H/W (hardware): machinery, instruments, supplies, dental materials, IVD medical device or IVD medical device reagents
K-GMP is described in our previous regulatory insight.
When is a Digital K-GMP change audit required?
A change audit is required when significant changes occur after obtaining the Digital K-GMP certificate, including the changes described below.
Change reason | Detail | Subject |
AI/ML function addition | When adding AI/ML functions | S/W |
Other type groups* addition | When a medical device hardware manufacturer adds a new product category | H/W |
Changes in process and service outsourcing | When newly outsourcing a part of the manufacturing process or services | S/W, H/W |
Location change | When changing or adding a manufacturing location (excluding storage facilities and laboratories) | H/W |
H/W and S/W supplier changes | When changing the digital medical device software manufacturer or manufacturing facility | H/W |
*Other type groups include machinery, instruments, supplies, dental materials, IVD medical device, IVD medical device reagents
When can alternative Digital K-GMP audits apply?
A reduced set of dossiers may be submitted for the Digital K-GMP audit if alternative audit conditions apply. The expiration date of the Digital K-GMP certificate will be aligned with the certificate being leveraged.
Alternative audit conditions may apply in the following cases:
- Another local distributor obtains the Digital K-GMP certificate under the manufacturer
- A valid K-GMP certificate is submitted in accordance with K-GMP regulations or the IVD K-GMP regulations, limited to medical device H/W and digital medical device S/W without AI/ML functionality
- A valid K-GMP certificate obtained by a medical device H/W manufacturer is submitted in accordance with K-GMP regulation or IVD K-GMP regulations, and the product group specified in the certificate falls within a type group* under the Digital K-GMP Regulation
- A copy of the Quality Management System certificate and audit report, including CAPA plan and actions, is submitted by the regulatory authority or a third-party agency designated by the regulatory authority, limited to medical device H/W
- A valid MDSAP certificate and audit report are submitted, limited to medical device H/W
* Digital medical device S/W: with AI/ML functionality, without AI/ML functionality
* Medical device H/W: machinery, instruments, supplies, dental materials, IVD medical devices, IVD medical device reagents
Note that some alternative audit conditions include the use of a valid certificate issued in accordance with K-GMP regulations, so these conditions may apply only temporarily.
If the certificate has expired, the renewal audit must be completed in accordance with the Digital K-GMP regulations.
Key takeaways for Digital K-GMP compliance
The ultimate goal of Digital K-GMP is to support the manufacture and sale high-quality digital medical devices. Our next Regulatory Insight will discuss key considerations for a Digital K-GMP audit based on our experience.
Emergo by UL can provide Digital K-GMP implementation and certification support, including support for on-site and remote audits.
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