In a First for Korean Companies, SK Bioland Acquires CE Certification from BSI in the UK for Medical Collagen Dental Material and is Now Poised to Directly Target the World’s Largest European Market



● First Korean company to acquire CE certification from British royal family-authorized BSI for collagen dental membrane products

● Spurs efforts to win new licenses and approval in other businesses, including medical equipment and food supplements, as well as natural materials for cosmetics

● Aims to emerge as a global healthcare material company by advancing into potential markets including Europe, the Americas, Asia, and the Middle East



SK Bioland (Jeong Chan-bok, CEO) has accelerated its foray into the European market, widely considered as the largest dental medical material market in the world. In a first for a Korean company, SK Bioland announced that it recently earned the Communaute Europeenne (CE) Marking certification for its collagen dental membrane (product name: OssGuide) from the UK’s British Standards Institution (BSI).



Collagen dental membrane is medical material that is essential for dental implant surgery as it helps bone to form speedily following implant treatment and soft tissue to recover quickly. In 2006, SK Bioland successfully developed medical materials using animal-sourced collagen (pig skin) by utilizing its own technology for the first time in Korea. This contributed to domestic production and supply of collagen-_ base_d medical materials; previously Korea was heavily dependent on imports for this demand. In addition to dental medical materials, the company has expanded the material’s application to include surgical material (Colladerm) and ophthalmic material (Eyecl-Cornea) by constructing mass production facilities and equipping itself with the necessary technology.

[Photo of Sample Products] 

SK Bioland’s collagen-_ base_d medical products


The collagen dental membrane market is affected by the size and growth pace of the dental implant market, which is the main buyer. Europe, which is the world's largest market accounting for 31.6% of the global dental implant market, is growing at an annual average rate of 7.4% to stand at 1.4 trillion won as of the end of 2016.



CE certification is an essential step in the company’s bid to enter the European market. In particular, the European Union’s medical material certification is a complex process that demands applicants meet a myriad of strict standards. "In order to enter the European market for collagen dental membrane products, we received CE certification from a validation body in the Czech Republic in 2013, and have supplied products to our major clients in EU member countries. However, we have sped up the process to win CE certification from BSI, known as one of the best validation agencies in the world, in order to preemptively cope with increasingly strict quality control standards for medical materials and consumers’ needs,” an SK Bioland official said. “The acquisition of the CE certification is testament to the quality competitiveness of SK Bioland's collagen dental membrane products." 

Established in 1901, BSI is an organization authorized by the British royal family. It is a global certification agency that has set the standard for 2,097 healthcare products worldwide, and processes and issues CE certification. It is known as one of the world's leading accreditation bodies as it has issued more than 35% of CE certifications for healthcare products from more than 150 countries worldwide. Now that SK Bioland has received the CE certification from BSI, which is famous for its ent standards, industry experts say that the company is well positioned to make a foray into the European market. In the wake of the acquisition of BSI’s certification for dental collagen membrane products, SK Bioland plans to rapidly increase its market share in the European dental material market by staging an aggressive marketing drive targeting global implant companies and local firms in Europe.



Apart from Europe, SK Bioland is aggressively moving to enter global markets, including the US, Asia, and the Middle East. The company acquired sanitary permission for its dental collagen membrane product (product name: T-Gen) from the China Food and Drug Administration (CFDA) in March last year, and is accelerating its inroads into the Chinese market. Currently, the company is in a supply agreement with local companies in China, Germany, Israel, and Iran, as well as global implant companies, and is expanding sales. It is also taking steps to win a license from the US Food and Drug Administration (FDA) to enter the US market.



SK Bioland CEO Jeong Chan-bok said, "With the acquisition of European CE certification from BSI, SK Bioland has secured the means to expand our global outreach from a China-centered global strategy to other regions, including Europe, the Americas, Asia, and the Middle East.” He added, “We will continue our efforts to acquire new certifications and licenses in other business areas, including medical materials and food supplements, and expand sales in order to transform from a company centered on natural cosmetics materials into a global general healthcare material enterprise."