Sunmax Biotechnology has become the first company in the world to receive the CE Medical Devices Directive certification for collagen implant products. DNV awarded the certificate to the Taiwan-based company, which sees it as a gateway to international markets.
Recognised as a pioneer in the field of biotechnology in Taiwan, Sunmax has developed its collagen product by using highly purified porcine dermal. To be used in plastic surgery and the abatement of wrinkles, creases and lines caused by ageing, this product is classified as a Class 3 product under the EU’s Medical Devices Directive (MDD).
David Wang, chairman of Sunmax, said: “This certification is a milestone for Sunmax and provides us with a gateway to the international market. It also proves that the biotechnology industry in Taiwan is at the forefront in this field.”
The EU’s MDD directive came into force in June 1993, as part of the process of removing barriers to free movement as well as securing of safety aspects of medical devices and products within the EU/EFTA states. For so-called ‘Class 3 products’ (products that are in the highest-risk class) the manufacturer must use a certification body to be able to affix the CE mark.
Jahn Henry Løvaas, DNV Certification’s director of operations Asia Pacific, commented: “Sunmax’s commitment to high standards is highly commendable. Having its product CE certified through a recognized international certification body like DNV is an effective and strong means to communicate the safety of its products to the international markets.”
He adds, “Interestingly, Sunmax considers CE marking as equally important for the Asian market as it does for the international markets.”
DNV is involved in the CE assessment of medical devices and products in Europe, America, Australia and Asia. Løvaas anticipates more CE work will follow, particularly in China and India, “the two pillars of the Asian economies.”