Publish Time: 2025-03-28 Origin: Site
The National Institute of Food and Drug Safety Evaluation (NIFDS), part of South Korea's Ministry of Food and Drug Safety (MFDS), has approved the A1c Go HbA1c kit(manufactured by Goldsite Diagnostics Inc. ) as a new class II device in March 2025. This is another major milestone for Goldsite's global reach following the exciting news last year. In 2024, the manufacturer successfully passed the Ministry of Food and Drug Safety (MFDS) audit and was granted the certification of Korea Quality Management System for Medical Devices (KGMP).
As a developed economy, South Korea has strict regulatory requirements for imported medical device products. All manufacturers of Class II to Class IV medical devices must pass a comprehensive MFDS audit and obtain KGMP certification before they can legally sell in the Korean market.
June 2024 Goldsite obtained KGMP certification after the on-site factory audit
The A1c Go HbA1c kit is an IVD designed to measure glycated hemoglobin (HbA1c) levels, a critical marker for assessing long-term blood glucose control in individuals with diabetes. HbA1c testing is essential for diagnosing diabetes and monitoring patient management, providing a snapshot of average blood sugar levels over two to three months.
Given the prevalence of diabetes and the demand for reliable testing solutions, the A1c Go HbA1c kit addresses a significant healthcare need, particularly in markets like South Korea, where diabetes management is a public health priority.
What is NIFDS and MFDS?Regulatory body in South Korea |
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The Ministry of Food and Drug Safety (MFDS), formerly known as the Korea Food and Drug Administration (KFDA), is the primary regulatory body in South Korea responsible for overseeing the safety and efficacy of medical devices, drugs, and other health-related products.
The National Institute of Food and Drug Safety Evaluation (NIFDS), an affiliate agency under MFDS, focuses on policy research, technical evaluation, and pre-market approvals. As the affiliated agency of MFDS, it plays a critical role in evaluating applications for 'New devices(Class Ⅱ)' and 'Class Ⅲ & Ⅳ Devices', ensuring they meet stringent safety and efficacy standards before market entry.
The Ministry of Food and Drug Safety (MFDS)
National Institute of Food and Drug Safety Evaluation (NIFDS)
Regulatory Compliance and Approval Process:
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Looking AheadExpand Global Reach |
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With the certification in hand, Goldsite Diagnostics Inc. is now poised to meet the growing demand for diabetes management solutions in South Korea. Goldsite team will continue to uphold the highest standards of medical device safety and innovation, striving to improve the lives of patients and healthcare providers alike.
The A1c Go HbA1c Kit certification is a key step forward in Goldsite Diagnostics Inc.’s mission to provide reliable, high-quality diagnostic solutions to the global medical community.
GOLDSITE DIGANOSTICS INC. is a leading manufacturer of IVD products dedicated to the healthcare sector. With over 25 years of expertise in the IVD industry, Goldsite has established itself as a trusted partner since 1999. With a team of experts in the field of diagnostics technology and a passion for improving healthcare, we strive to bring cutting-edge products to market that meet the evolving needs of health providers and patients. Engaged in R&D, manufacturing, and marketing of clinical laboratory devices and reagents, Goldsite has a portfolio of products covering specific proteins, chemistry, chemiluminescence, POCT platform, and associated reagents. All products live up to global standards with CE marking and have been exported to over 100+ countries.
For more information about Goldsite Diagnostics Inc. and the HbA1c Analyzer GSH-60, please visit: www.goldsite.com.cn
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