MegaGen Implant, acquired ‘CE MDR’ for the first time as an implant company in Korea.

2022-12-16 19:42
Author
마케팅
Date
2022-12-16 19:42
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517


 

MegaGen Implant, acquired ‘CE MDR’ for the first time as an implant company in Korea.

 

- Satisfies global-level quality, performance & safety requirements

- Korea’s first implant certification, establishing a bridgehead for global expansion

- Date: Dec. 2022

 

MegaGen Implant Co., Ltd. (CEO Park Kwang-bum, hereinafter referred to as MegaGen) announced that it had obtained CE MDR (Medical Devices Regulations) certification, which is a European medical device regulation with enhanced quality system and product performance and safety requirements, for Korea’s first time as dental implants. This certification was obtained from DNV(2460), an examination agency affiliated with TEAM NB (The European Association for Medical devices of Notified Bodies). The conferment ceremony was held at MegaGen Implant Daegu headquarters on December 2nd, and Lee Jang-seop, CEO of DNV Korea, the screening agency, attended.

The product that obtained the CE MDR certification this time is the ‘XPEED AnyRidge Internal System’, which contains MegaGen’s patented technology. Its special feature is the 'XPEED surface treatment' technology, which deposits calcium on the surface of the implant fixture so that the bone and implant can adhere well after the implant procedure. In addition, it features a unique 'KnifeThread' design that shortens the healing period by securing high initial fixation with a sharp blade-shaped spiral design. With this certification, MegaGen became the first company to obtain CE MDR certification in the domestic dental implant industry in Korea.



The CE MDR certification was enacted by revising and legislating the existing Medical Device Directive (MDD) created in 1993 by the European integration organization CE (Conformite Europeenne) with higher quality and safety standards. It is a new European medical device regulation with stringent requirements such as validity and stricter verification. CE MDR is an international certification that must be obtained in order to export products to Europe, but many companies have difficulties in obtaining certification as preparations and procedures take considerable time and money. MegaGen prepared for certification immediately after the implementation of the MDR in May 2021, and obtained certification for the first time in Korea as an implant system in 1 year and 6 months.

This certification proves that MegaGen is a result of preemptively responding to the strengthened regulations, and that it provides safe and reliable products for successful implant treatment to customers by complying with all requirements and global-level quality capabilities. It is noteworthy that it did. In addition, MegaGen, which has been certified for its technology and quality with K-implants and is the No. 1 exporter from Korea to Europe and the United States, is drawing attention in that it has secured a bridgehead to solidify its status as a global implant through CE MDR certification.

Dr. Kwang-Bum Park, CEO of MegaGen, said, “Acquiring CE MDR certification is the most gratifying thing recently.” This is a result obtained by identifying the required certification in advance and responding quickly, and despite strict standards and procedures, MegaGen's quality excellence was recognized.” He also said, "As the first certification of MDR certification, which has been strengthened through post-monitoring, management and control, has been resolved, we will use the European market as a stepping stone to expand the global market more actively."

Meanwhile, MegaGen, a company specializing in dental medical devices established in 2002, is currently exporting implants and medical devices to more than 100 countries around the world, including Europe, the United States, and the CIS. It has the highest share in the European market among Korean companies, winning successive awards such as '$100 Million Dollar Export Tower' this year and '$ 70 Million Export Tower' in 2020. In 2021, it is recording a steep rise due to continuous employment expansion, such as achieving $ 100 million in exports and being the only dental industry selected as the ‘2022 Korea Best Employer’ by the Ministry of Employment and Labor.

For more information, such as inquiries on MegaGen's products, visit MegaGen's official website (https://imegagen.com/), and to find your local dealer please visit at https://imegagen.com/about/contact/global_network/

For more detail on AnyRidge system: https://imegagen.com/product/1292/

#MegaGen #MegaGenImplant #AnyRidge #MDR #CEMDR #Firstimplant #LifetimeforSmile #BlueDiamond #XPEED