Elkem successfully submits first Master Access File (MAF) for SILBIONE™ BIOMEDICAL
Elkem’s SILBIONE™ Biomedical HCRA M500 Series products are the first in the silicone industry to complete the national MAF registration with NMPA.
The MAF contains biocompatibility test data and a toxicological overview. The acceptance of the MAF enables Elkem to provide medical device customers with professional regulatory support, especially those that may manufacturer implantable devices that stay in the body for greater than 29 days.
Elkem Silicones’ mission is to provide innovative materials that shape a better and more sustainable future. We are committed to using technological innovation and providing our customers with best in class regulatory support, thereby empowering them to improve people's quality of life. We continue to expand our SILBIONETM Biomedical long-term implantable medical-grade silicone product range, which have been widely used and recognized by customers in the global medical market.
Now, through the combined efforts of Elkem’s regulatory teams based in China and USA, the SILBIONETM Biomedical HCRA M500 series MAF has been successfully accepted by both the Medical Device Evaluation Center of the China National Medical Products Administration and the Center for Devices & Radiological Health of the United States Food & Drug Administration.
"China is one of our most important markets. In the past few years, Elkem Silicones has made a lot of investment and deployment. From the ISO 13485 certified medical clean workshop to the establishment of a fast-responding localized professional team, it shows that Elkem Silicones The ambition for the Chinese market; as the first silicone material supplier to complete the registration of the master file for medical devices in China, this also fulfills our commitment to Chinese medical customers." said August Zhang, Asia Pacific Specialty Products Marketing Director of Elkem Silicones.
" SILBIONETM Biomedical HCRA M500 master file registration is completed, which can facilitate our customers' medical device registration, modification and clinical trial approval in preparation for entering the Chinese market; Elkem Silicones has established professional regulations, technical support and business team locally,to serve our fast-growing Chinese medical and health market, and has also fulfilled our commitment to delivery our customer potential " said Stone Chu, Asia Pacific Marketing Manager of Elkem Silicones Healthcare.
Elkem’s commitment to Sustainability
Sustainability is central to our business strategy. Our mission is to provide advanced material solutions shaping a better and more sustainable future, adding value to our stakeholders globally.
Elkem defines sustainability work as continuous efforts to maximise our positive impact on the environment and societies around us, as well as to minimise any negative impact. As a global company, we affect the environment and communities around the world every day. And through the products we make, we have a foot print in our supply chain and make new solutions possible.
Disclosure is a primary part of this engagement, and we can proudly state that in 2020, Elkem received a Gold rating from Ecovadis and was ranked by CDP in the Climate A List.
Read more at Sustainability | Elkem.com
About Elkem Silicones
Elkem Silicones has more than 4 200 employees dedicated to delivering your potential by providing you innovative silicone solutions with a personal touch. Elkem Silicones, a division of Elkem, is a global leader in fully integrated silicone manufacturing, operating 14 multi-functional manufacturing sites and 13 Research & Innovation centers around the globe. Elkem Silicones offers a full range of silicone technologies for diverse specialty markets including aerospace, automotive, construction, consumer goods, energy, healthcare, paper, personal care and textiles. Elkem Silicones is committed to create new, innovative and green solutions and business models that promote a sustainable future. To learn more, please visit Elkem Silicones Website
About Elkem ASA
Elkem is one of the world’s leading providers of advanced material solutions shaping a better and more sustainable future. The company develops silicones, silicon products and carbon solutions by combining natural raw materials, renewable energy and human ingenuity. Elkem helps its customers create and improve essential innovations like electric mobility, digital communications, health and personal care as well as smarter and more sustainable cities. With a strong track record since 1904, its global team of more than 6,800 people has a joint commitment to stakeholders: Delivering your potential. In 2020, Elkem was rated among the world’s top 5% on climate and achieved an operating income of NOK 24.7 billion. Elkem is listed on the Oslo Stock Exchange (ticker: ELK). To learn more, please visit Elkem Website