Digital K-GMP Audits Under the DMPA: Key Considerations

By Sora Lee

Digital K-GMP and the DMPA: Background for manufacturers

Our first Regulatory Insight described the Digital Medical Products Act (DMPA) and Digital Korea Good Manufacturing Practice (Digital K-GMP). It also compared the K-GMP requirements with those that digital medical devices must meet to secure Digital K-GMP certification. 

In this Regulatory Insight, we share our experience with Digital K-GMP audits and the DMPA. 

Digital K-GMP audit: Three key considerations

Based on our experience with K-GMP and Digital K-GMP audits, three areas to emphasize are gap analysis/impact assessment, verification and validation, and understanding cybersecurity and electronic infringement. As a first step, Emergo by UL recommends performing a gap or impact assessment of the change. 

Conducting a gap analysis and impact assessment

Even though the Digital K-GMP regulation incorporates substantial content from IEC 62304:2015, manufacturers may overlook the need for a gap analysis and assume they already comply with the regulation.

However, with the implementation of the DMPA and the related Digital K-GMP regulation, manufacturers must compare their existing quality management system (QMS) to Digital K-GMP requirements, identify any gaps, and establish and execute corrective action plans for areas that are not yet compliant.

Verification and validation for digital medical devices

With digital medical devices, the concept of finished product inspection may not be applicable, and verification and validation are even more critical.

Therefore, manufacturers should prepare comprehensive verification and validation evidence generated during the design and development process, as well as evidence completed before final product release.

Cybersecurity vs. electronic infringement under Digital K-GMP

The cybersecurity requirements and the Security Guidelines for Electronic Infringement on digital medical devices are quite similar. However, the guidelines include specific requirements, such as reporting to the Ministry of Food and Drug Safety (MFDS) in the event of an electronic intrusion and post-market monitoring. These requirements should therefore be considered separately from general cybersecurity requirements.

Digital K-GMP audit experience: What to expect

It has taken time for the MFDS to implement the new act regarding software as a medical device (SaMD) and software in a medical device (SiMD), along with the corresponding QMS (Digital K-GMP) regulations. The audit agency, applicable regulations and audit types differ from those of the K-GMP. Furthermore, as these are software-specific regulations, Digital K-GMP audits are conducted with greater emphasis on software. The DMPA and Digital K-GMP are new to many digital medical device manufacturers. 

Digital K-GMP support for digital medical device manufacturers

Since the implementation of the relevant acts and regulations, Emergo by UL has successfully supported several Digital K-GMP audits, which require specialized software and regulatory expertise. 

Overseas manufacturers often face challenges in navigating the procedures due to the language barrier and the Korean-written standards set by the MFDS. Emergo by UL offers experts in Digital K-GMP who can provide guidance in understanding and navigating the Korean requirements. 

In addition, our Digital K-GMP expert can accompany the auditor during on-site and remote audits. This presence supports accurate interpretation, helps address any misinterpretation that may arise, and facilitates a smooth, effective audit.

How a Korea License Holder (KLH) supports overseas manufacturers

For Digital K-GMP audits of overseas manufacturers, the local distributor is the primary point of contact with the National Institute of Medical Device Safety Information (NIDS). As a Korea License Holder (KLH), Emergo by UL serves as the intermediary, managing the process from the Digital K-GMP audit application through post-audit follow-up activities. This can also include coordinating travel arrangements for the auditors.

Digital K-GMP compliance: Key takeaways 

Emergo by UL offers Digital K-GMP implementation and certification support, including on-site and remote audit support. The ultimate goal of Digital K-GMP is to support the manufacture and sale of high-quality digital medical devices.

Our next article will cover the DMPA in greater detail.