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Elkem Silicones Registered as First Supplier Completing Master File for Medical Devices
Source: ChemChina Date: 2022-01-14

Through the cooperation of Elkem’s Chinese and US regulatory teams, the SilbioneTM Biomedical HCRA M500 series has been successfully reviewed by the Medical Device Review Center of the State Drug Administration of China, with a master file registration for medical devices completed. This is the first product in the silicone industry to complete the master file registration for national medical devices.

Silbione? Biomedical solid silicone rubber is a series of two-component, platinum-catalyzed and heat-vulcanized silicone elastomeric materials. These materials are suitable for molding and extrusion processes and can be used to produce medical products or related applications that are required to be implanted into a human body for more than 30 days.

“As China is one of our most important markets, Elkem Silicones has made a lot of investments and layouts over the past years from the ISO13485 certified medical cleanroom to the building of a fast-responding localized professional team, demonstrating its ambition for the Chinese market. We have honored our promise to Chinese medical customers as the first silicone material supplier to complete the master file registration for medical devices in China,” said Zhang Qunli, marketing director of the specialty product division of Elkem Silicones for the Asia Pacific region.

 “The completion of the SilbioneTM Biomedical HCRA M500 master file registration will facilitate our customers’ registrations, changes and clinical trial approvals of medical devices for entry into the China market. Elkem Silicones has assembled regulatory, technical and commercial teams in Shanghai to serve our fast-growing Chinese health care market, which is in line with our commitment to expand our customers’ potentials.” Chu Yuyun, marketing manager of Elkem Silicones Healthcare for the Asia Pacific region, said.

With the mission of continuous innovation and social responsibility, Elkem Silicones is committed to using technological innovation to help improve the quality of people’s lives. With the continuous expansion of Elkem’s SilbioneTM Biomedical long-term implantable medical silicone products, the series has been widely applied and recognized by customers in the global medical market.
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