11/26/2021 | Press release | Archived content
Seoul, South Korea, 26 November - MicroPort NeuroTech (Shanghai) Co., Ltd. (MicroPort® NeuroTech) recently received the Korea Good Manufacturing Practice (KGMP) certification, a quality system standard for medical devices in South Korea, following a review by the Ministry of Food and Drug Safety of Korea (MFDS). This certification further signals that MicroPort® NeuroTech has established a world-leading quality management system, as it follows the securement of various system certifications, including ISO13485:2016 and the ANVISA certification by the Brazilian National Health Surveillance Agency.
In recent years, the medical device market in South Korea has grown with momentum, placing it as a top-four market in Asia in terms of market size. Imported medical devices, mainly from the United States, the EU and Japan, account for nearly 60% of its market share. It is mandatory for manufacturers of Class II-IV medical devices to obtain a quality system certification before entering the South Korean market. In order to receive the KGMP certification, MicroPort® NeuroTech underwent a full spectrum of audits and evaluations by the MFDS on product design and development, procurement, manufacturing, and service provision.
Adhering to the core value of quality, MicroPort® NeuroTech strictly complies with domestic and international regulations and standards for medical devices throughout the product life cycle, from product design and development to manufacturing and marketing. It has established a comprehensive quality management mechanism centered on a quality-oriented culture, quality systems, quality assurance tools and a quality foundation, to ensure the stability and continuous improvement of the standard of its products and services.
As an international recognition of the company's quality management system, the KGMP certification has laid a solid foundation for MicroPort® NeuroTech to enter the South Korean market with its self-developed products. MicroPort® NeuroTech will take this opportunity to further improve and enhance its products and services, and provide trustworthy and inclusive medical solutions to more patients with cerebrovascular diseases.
About MicroPort® NeuroTech
Shanghai MicroPort NeuroTech Co., Ltd is a subsidiary of MicroPort Scientific Corporation (00853.HK). Founded in 2012, MicroPort® NeuroTech is a high-end medical device company focused on neuro-intervention that provides a range of neuro-interventional products to treat a variety of brain conditions. In the future, MicroPort® NeuroTech will invest more resources in innovation and development to provide more high-quality and innovative solutions for cerebrovascular and neuro interventions for doctors and patients.