Changzhou Haida Medical Equipment Co., Ltd. obtained The Korean Medical Device Quality System KGMP certification

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Author : Rachel
Update time : 2023-09-07 08:38:46

Changzhou Haida Medical Equipment Co., Ltd. obtained The Korean Medical Device Quality System KGMP certification

Changzhou Haida Medical Equipment Co., ltd. It has successfully passed the review of the Korean Ministry of Food and Drug Safety (Ministry of Food and Drug Safety, MFDS), and obtained the certification of the Korean Medical Device Quality System Korea Good Manufacturing Practice (KGMP). Up to now,Haida Medical has successively obtained ISO13485:2016, TüVRheinland CE certification and other system certifications, forming an international level of quality management system.

In recent years, the medical device market in South Korea has grown rapidly, and the market size has ranked among the top four in Asia, among which, imported medical devices account for about 60% of its market share, and the main import sources are the United States, the European Union and Japan. KGMP certification is a quality system certification for medical devices before entering the Korean market, Changzhou Haida Medical Equipment Co., ltd. in the process of obtaining KGMP certification, we accepted the comprehensive review and comprehensive evaluation of Korean MFDS for design and development, procurement, production and service provision.

"Quality" is the core value of the Changzhou Haida Medical equipment Co., Ltd. In order to ensure the stability of product and service quality and continuous improvement, Changzhou Haida medical in product design, development, manufacturing and marketing in the whole life cycle of management process strictly abide by the domestic and foreign medical device regulations and standards, formed by quality culture, quality system, quality tools and quality basis of comprehensive quality management mechanism.

The KGMP certification is the recognition of the company's quality management system in the international market, and also lays a solid foundation for Changzhou Haida Medical's self-developed products to enter the Korean market. Changzhou Haida Medical will take this opportunity to further improve and improve the quality of products and service, and we are committed to providing more minimally invasive surgery solutions and patients with high value of minimally invasive surgical instruments.

 As a branded China minimally invasive surgical instruments manufactuer, Haida medical manufacture top-tier quaity laparoscopic trocar, optical trocars, endo retrieval bags, endoscopic linear cutter and articulating staplers and reloads, skin staplers, circumcison staplers, circular staplers, etc. viarous surgical stapling instruments. With over 20 years clinical experience we bring our customer high quality surgical stapling products , endoscopic surgical instruments and consistent solutions to open surgeries and minimally invasive surgical procedures.

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