Korea Medical Device GMP (K-GMP) Compliance and Challenges

By Sora Lee

As discussed in our first regulatory update,  compliance with K-GMP (Korea Good Manufacturing Practice) is required for Class 2, 3 and 4 medical devices.

Therefore, the K-GMP certificate is an integral step to entering the market in South Korea.

K-GMP audits

There are four types of K-GMP audits: initial, additional, change and renewal.

We describe them here:

Initial audit: Pre-approval audit of manufacturers for conformance with K-GMP.

Additional audit: When manufacturers want to add a new product category in addition to the product category that has already obtained a K-GMP certificate, this audit is required. It’s based on the K-GMP category stipulated by the K-GMP.

Change audit: If a K-GMP-certified manufacturing site changes location (transfer, expansion, reduction, etc.) an additional change K-GMP audit is required.

Renewal audit: Medical device manufacturers need to undergo renewal audits every three years for compliance with K-GMP. The K-GMP renewal application must be submitted at least three months before the K-GMP certificate expires.

Note that MDSAP certificates can be used to waive an on-site K-GMP audit. This will be discussed in our next regulatory update.

K-GMP auditing organizations

The auditing organization involved is dependent on the risk classification of the devices. This is presented in the table below.

Different K-GMP audits and the auditing agencies

* Class 1 is exempt from K-GMP audits and can be replaced by the notification process.

* MFDS and TPA conduct joint audits of Class 3 and 4 devices. The review scope of the two agencies is different.

What does MFDS/TPA specifically assess in a K-GMP audit?

Critical area:

Establish a record maintenance/management period

Records should be maintained for a duration that corresponds to the product life cycle, as well as any specific preservation periods mandated by K-GMP.

Focus on how to identify medical devices

All medical devices from Class 1 to Class 4 are assigned a UDI and must utilize the Global Standard #1 (GS1) system defined by MFDS, consisting of UDI-DI and UDI-PI.

Be thoroughly prepared for UDI (Unique Device Identification) for every product.

The UDIs assigned to all medical devices must be registered in the MFDS Portal by KLH before distributing the product in South Korea, and each manufacturer must have internal procedures for assigning and managing UDIs.

Maintain traceability records for medical devices subject to tracking according to Article 49 of Enforcement Regulation of Medical Devices Act.

K-GMP defines medical devices subject to tracking as devices that are implanted into the human body for more than a year and life-support medical devices that can be used outside of medical institutions. It is essential to maintain traceability records of these devices throughout the entire manufacturing process, release, and subsequence stages to ensure accountability and monitoring.

Be prepared in case you need to report to regulatory authority

Prepare and implement vigilance procedures according to the MFDS requirements in case you need to report any adverse events, incidents, or potential risks to the authorities. Depending on each report has a different deadline. It is critical to report it on time.
 

Common Challenges of K-GMP audits: Fundamental

The most impactful part of a K-GMP audit is “interpretation” since the K-GMP audit is conducted in the Korean language. The manufacturer is responsible for arranging an interpreter who specializes in medical devices.

If the interpreter is not familiar with the K-GMP and only literally translates the auditor’s comments, this often leads to miscommunication and misunderstanding between the auditor and the manufacturer.

Furthermore, if the manufacturer is unable to provide the required documentation because of an interpreter’s misinterpretation, this can also have a direct impact on the audit result.

Suppose the auditor(s) determines that the full scope of the audit cannot be effectively completed during the scheduled audit days (typically 4-5 days) due to poor interpretation. In that case, MFDS/TPA can withdraw from the audit midway.

In this case, the audit result will be “non-conformance” and the manufacturer that arranges the interpreter will assume all responsibility for the audit results.

Common challenges of K-GMP audits: Marketing authorization and DMR

One of the common challenges is the marketing authorization (product license) and Device Master Record (DMR).

To obtain a product license from MFDS, the manufacturer provides the regulatory documents to the KLH (Korean License Holder). The KLH submits the Korean documentation.

The MFDS will issue a product license, written in Korean, which is one of the critical documents that must be submitted when applying for a K-GMP renewal audit.

During the K-GMP renewal audit, the auditor checks whether the product license (raw materials, intended use, test standards, etc.) is consistent with the latest DMR.

In this case, the most common findings are inconsistencies between what is submitted in the product license compared to the DMR.

This can be a major finding if the product license is incorrect, or a minor finding if the DMR is incorrect.

If the DMR is revised due to a change in the design, the manufacturer should proceed with the change licensing at the same time. On the other hand, if the product license is revised due to a change in the design, the DMR should have been revised at the same time. However, most manufacturers do not mirror the change in the DMR and product license, resulting in a non-conformance finding.

Common challenges of K-GMP audits: AI request

One common challenge during the post-audit follow-up phase is when an Additional Information (AI request) is issued. In such cases, the manufacturer is required to provide a supplementary response within the timeframe specified by the MFDS/TPA. Both the importer and the manufacturer are responsible for preparing and compiling all the necessary supplementary documents and ensuring their timely submission to the MFDS/TPA. The 1^st AI response for the audit findings occurs one month after receiving the official audit results document from the MFDS/TPA.

If the manufacturer is unable to prepare the AI within this timeframe, the importer has the option to request an extension by submitting an official document to the MFDS/TPA, along with valid justifications. While there is no specific definition for the duration of an extension, it is typically granted for one month, and up to two extensions may be allowed.

In cases where the data provided in the first AI response submission is deemed insufficient, the MFDS/TPA may issue a second AI request. The timeframe for submitting the second supplementation is 10 days.

Failure by the manufacturer/KLH to submit the requested documents within these two opportunities will result in a non-conformance as the final audit outcome, despite the completion of the K-GMP audit.

Successfully navigating MFDS procedures and standards

As mentioned above, several requirements are especially important to MFDS. Of these, reporting adverse events is the most important.

Overseas manufacturers often face challenges in navigating the procedures due to the language barrier and the Korean-written standards set by the MFDS. However, to address this issue, Emergo by UL offers the expertise of consultants who are experts in K-GMP. These consultants can provide assistance and guidance in understanding and meeting Korean requirements.

The local distributor is the primary point of contact with MFDS/TPA for K-GMP audits of overseas manufacturers. As a KLH, Emergo by UL  serves as the intermediary, assuming responsibility for all aspects, starting from the application for the K-GMP audit to the follow-up activities after the audit. This also includes coordinating audit travel arrangements for the auditors.

In addition, a consultant with K-GMP expertise can accompany the auditor to the K-GMP on-site audit and act as a supporter to correct any errors in interpretation and smoothly proceed with the audit. Furthermore, our K-GMP expert can accompany the auditor during the on-site audit at your facility. Their presence facilitates the auditor’s comments, provides accurate interpretation and addresses any misinterpretation that may arise, thereby facilitating a smooth and effective progression of the audit.

Selling high-quality medical devices

The ultimate goal of K-GMP is to manufacture and sell high-quality medical devices.

Emergo by UL can help with your K-GMP implementation and certification, including on-site audit support.