● REMAFIN® Plus products made in China have obtained GB / T16886 standard certification
● Support SFDA requirements for Class II and III medical device materials
● REMAFIN® Plus will be unveiled at MEDTEC China in Shanghai, September 26-28, 2018
Shanghai, September 13, 2018-Clariant, a global leader in specialty chemicals, announced that it will expand its masterbatch and compound series 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 China's State Food and Drug Administration (SFDA) accredited laboratory and meet the requirements of GB / T16886.
MEDTEC China, the international medical device design and manufacturing technology exhibition, will be held in Shanghai from September 26th to 28th, 2018. At that time, experts from Clariant Medical Polymer Solutions will be in booth D202. The industry-leading MEVOPUR® and REMAFIN®-EP masterbatches and modifiers tailor-made for medical applications answer questions for visitors.
As China further develops the Medical Devices and Supervision Regulations (MDSAR) regulatory framework, the revised classification method for medical devices has entered into force in August 2018. Some medical devices are reclassified as Class II or III, which means that some technical and regulatory requirements for the materials used to make such devices will increase. In addition, the SFDA has also increased the frequency of inspections, introduced an unannounced review system, and verified the compliance of materials and processes. The SFDA also requires GB / T16886 standard tests similar to the ISO10993 international standard for Class 2 and Class 3 devices, and evaluates the biocompatibility of the raw materials used. In order to meet the new standards with materials that have been in use for many years, this may be a huge challenge.
At the REMAFIN Plus launch, Stephen Duckworth, global director of Clariant Medical Polymer Solutions, said: "China is introducing similar regulatory measures to other countries, which means that medical device manufacturers need to re-evaluate the plastic raw materials used for many years. Applicability. Our MEVOPUR series is a perfect solution that was developed specifically to support regulatory compliance with international standards. We recognize that replacing existing medical device manufacturing materials often means recertification .But this method is costly and time consuming. However, with REMAFIN Plus, we are able to avoid such costs for the product, whether it is an existing product from Clariant or a product from a competitor. "
REMAFIN Plus includes a series of polyolefin-based masterbatches manufactured at Clariant's Shanghai and Guangzhou plants that are ISO9001 certified. The service portfolio can provide laboratory certification in accordance with GB / T16886 standard.
Duckworth said, "Obviously, REMAFIN Plus cannot 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 launched MEVOPUR Product line. Clariant has been working hard to adapt to the changing new needs of customers. REMAFIN Plus provides a way to respond to China's local regulatory requirements. "