REMAFIN® Plus products produced in China are certified according to GB/T16886 standard
Support SFDA requirements for Class 2 and Class 3 medical device materials
REMAFIN® Plus will be unveiled at MEDTEC China in Shanghai from September 26th to 28th, 2018.
Shanghai, September 13, 2018 – Clariant, the world's leading specialty chemicals manufacturer, announces that it will expand its masterbatches and compound portfolios for the medical device and pharmaceutical industries to meet the needs of the medical device industry. 'REMAFIN® Plus ' Products and services are based on locally produced products and have been certified by the China Food and Drug Administration (SFDA) accredited laboratory and meet the requirements of GB/T16886.
MEDTEC China will be held in Shanghai from September 26th to 28th, 2018. At that time, Clariant's medical polymer solutions experts will be at booth D202, on REMAFINPlus and The industry-leading MEVOPUR® and REMAFIN®-EP masterbatch and modified materials series tailored for medical applications, answering questions for visitors.
As China further develops the Medical Device and Supervision Regulations (MDSAR) regulatory framework, the revised medical device classification method has been in effect since August 2018. Some medical devices have been reclassified as Category 2 or Category 3, which means Some technical and regulatory requirements for materials used to make such devices will increase. In addition, SFDA has increased the frequency of censorship, introduced a surprise review system, and verified the compliance of materials and processes. SFDA also requires Test the GB/T16886 standard similar to the ISO10993 international standard for Class 2 and Class 3 instruments, and evaluate the biocompatibility of the raw materials used. In order to meet the new standard requirements for materials that have been used for many years, this may be a huge challenge.
At the REMAFIN Plus conference, Stephen Duckworth, global director of Clariant's Medical Polymer Solutions, said: 'China is introducing regulatory measures similar to those in other countries, which means that medical device manufacturers need to reassess the long-term use of plastic raw materials. Applicability. Our MEVOPUR range is the perfect solution for developing regulatory compliance that meets international standards. We recognize that replacing existing medical device manufacturing materials usually means recertification. However, this method is costly and time consuming. However, with REMAFIN Plus, we are able to avoid such costs, whether it is Clariant's existing products or competitors' products.
REMAFIN Plus consists of a range of polyolefin-based masterbatches produced from the Clariant Shanghai and Guangzhou plants certified to ISO 9001. The service portfolio is available in accordance with the GB/T16886 standard.
Duckworth said: 'It is obvious that REMAFIN Plus does not meet the needs of Chinese equipment export manufacturers. Their plastic raw materials need to meet international regulatory requirements, meet ISO13485 and GMP standards, and adopt robust change control measures. To this end, we have launched MEVOPUR. Series products. Clariant has always strived to adapt to the changing needs of its customers. REMAFIN Plus provides a way to respond to China's local regulatory requirements.'