Elkem Silbione completes MAF registration with NMPA

Oslo, Norway – 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.

Now, through the combined efforts of Elkem’s regulatory teams based in China and USA, the SILBIONE^TM 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.

” SILBIONE^TM 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.