Tuesday, April 16, 2024

Korea Enhances Medical Device Regulations with New K-GMP Audit System

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The enactment of Law 419/2024 is a pivotal moment for Korea’s healthcare sector, demonstrating the government’s dedication to upholding the highest standards of quality and safety in medical device manufacturing. By categorizing audits into initial, additional, change, and renewal, the law provides a comprehensive framework that addresses various aspects of manufacturing and quality assurance processes. This structured approach not only facilitates better compliance among manufacturers but also aims to enhance the overall reliability and efficacy of medical devices available in the market.

Furthermore, this regulatory enhancement is expected to foster innovation by encouraging manufacturers to continuously improve their products and processes within a well-defined regulatory environment. The introduction of this law is a clear indication of Korea’s commitment to aligning its medical device sector with international best practices, thereby strengthening its position in the global healthcare industry. With these changes, Korea is set to create a more transparent, efficient, and effective regulatory ecosystem that benefits manufacturers, healthcare professionals, and patients alike, ensuring that medical devices produced and sold meet the highest standards of quality and safety.

The initial audit serves as a pre-approval check for manufacturers to verify their compliance with K-GMP standards before market entry. Additional audits are necessitated when manufacturers seek to introduce new product categories already certified under K-GMP, ensuring extended product lines also meet required standards. Change audits are mandated when there’s a significant alteration in the manufacturing site’s location, including expansions or reductions, to ensure continuous compliance. Lastly, renewal audits are conducted every three years to maintain K-GMP certification, emphasizing the ongoing commitment to quality and safety.

Enhancing Safety Through Rigorous K-GMP Audits and UDI Implementation

The recent legislative changes underscore the commitment to enhancing the quality and safety of medical devices available in Korea. Central to this regulatory shift is the establishment of a robust auditing system, managed by authorized organizations depending on the device’s risk classification. Notably, class 1 devices are exempt from K-GMP audits, while class 2 to 4 devices undergo comprehensive evaluations involving both desktop and on-site audits by designated third-party auditors (TPA) and the Ministry of Food and Drug Safety (MFDS).

These reforms also introduce a keen focus on critical areas during the K-GMP audit process, such as establishing a record maintenance period aligned with product lifecycles and K-GMP requirements, the adoption of the Unique Device Identification (UDI) system for device traceability, and the establishment of vigilance procedures for reporting adverse events and incidents to regulatory authorities promptly.

The K-GMP audit process is fraught with challenges, particularly regarding language barriers and the interpretation of regulatory directives during audits. Misinterpretation can lead to miscommunication, potentially affecting audit outcomes. Moreover, the alignment of marketing authorizations and Device Master Records (DMR) with current manufacturing practices poses another hurdle, often leading to non-conformance findings if discrepancies arise.

Medical Device

New Approaches in Drug Reimbursement and Medical Device Quality Assurance

The introduction of managed entry agreements (MEAs) and an electronic procurement system alongside fixed budgets reflects an innovative approach to drug purchasing and reimbursement based on patient outcomes, especially for those with chronic conditions. This shift towards more dynamic regulatory practices indicates a significant evolution in Korea’s healthcare landscape, aimed at improving access to effective and affordable medical treatments.

With the implementation of these new laws and guidelines, Korea aims to not only maintain but elevate the standard of medical devices within its borders, ensuring that they meet the highest quality and safety standards. This commitment is further underscored by the establishment of an innovative pharmacovigilance guide, setting the stage for a more rigorous and responsive regulatory environment.

 

Resource: Emergo by UL, March 21, 2024

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