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14 九月 2018

Clariant introduces REMAFIN® Plus service concept supporting SFDA medical device requirements for materials


• REMAFIN® Plus produced in China available with certificate to GB/T16886
• Supports local SFDA requirements for materials used in Class II and III devices
• Introduced at MEDTEC China Shanghai on 26 to 28th September 2018

Shanghai, September 13, 2018 -- Clariant, a world leader in specialty chemicals announces an extension to its range of color masterbatch and compound products designated for the medical device and pharmaceutical industry tailored to the needs of the medical device industry. The ‘REMAFIN®-Plus’ is a product and service offering based on locally produced products that will be available with certificates from Sino-Food and Drug Administration (SFDA) approved laboratories to the standard GB/T 16886.

Experts from Clariant’s Healthcare Polymer Solutions are on hand in Booth D202 at the MedTec China exhibition at the Shanghai World Expo Exhibition and Convention Center from 26-28th September 2018 to answer questions on REMAFIN Plus and the industry leading MEVOPUR®, REMAFIN®-EP range of concentrates and compounds specifically developed for Healthcare applications.

As China further develops the regulation framework under the MDSAR (Medical Device and Supervision Regulations) revised classifications of medical devices came into force in August 2018. Some devices have been reclassified to Class II or Class III meaning some of the technical and regulatory requirements are increased for the materials used to manufacture the devices. In addition SFDA has been increasing frequency of audits and introducing unannounced audits and is checking whether materials and processes are in compliance. Class II and III devices require devices to be tested to GB/T 16886; similar to international standard ISO10993 and assesses biocompatibility of raw materials used. This may be challenging where materials used for many years need to meet a new requirement.

In launching REMAFIN Plus, Stephen Duckworth, Global Head of Healthcare Polymer Solutions, Clariant Business Unit Masterbatches, comments, “China is introducing measures similar to other countries that mean medical device manufacturers need to reassess suitability of the plastic raw materials they have used for many years. Whilst our MEVOPUR range might be the perfect solution, since the product was developed specifically to support regulatory compliance to international standards, we recognize that for an existing medical device, changing material usually means revalidation is necessary. This can be expensive and take a long time. With REMAFIN Plus we offer the possibility of avoiding these costs either for an existing Clariant product or one sourced from competitors.”

REMAFIN Plus includes a selected range polyolefin-based masterbatch concentrates and manufactured under ISO9001 certified plants Clariant plants in Shanghai and Guangzhou. The service package will provide test certificates to GB/T 16886.

“It is clear that the REMAFIN Plus will not satisfy device manufacturers who export from China and will increasingly need their plastic raw materials to meet international regulations, produced under ISO13485 GMP and with robust change control measures.” states Duckworth. “For this we offer MEVOPUR. However, at Clariant, we always try to adapt to new and changing needs from our customers, and REMAFIN Plus offers a pathway to address local requirements in China.”

For more information, visit Clariant at www.clariant.com/mevopur.


Color concentrates used in Class II or III devices now need to comply with SFDA regulation GB/T16886. (Photo: Clariant)

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STEFANIE NEHLSEN
Phone +41 61 469 63 63
stefanie.nehlsen@clariant.com ECHO HE
Phone +86 21 2248 30 81
echo.he@clariant.com

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www.clariant.com

Clariant is a globally leading specialty chemicals company, based in Muttenz near Basel/Switzerland. On 31 December 2017 the company employed a total workforce of 18 135. In the financial year 2017, Clariant recorded sales of CHF 6.377 billion for its continuing businesses. The company reports in four business areas: Care Chemicals, Catalysis, Natural Resources, and Plastics & Coatings. Clariant’s corporate strategy is based on five pillars: focus on innovation through R&D, add value with sustainability, reposition portfolio, intensify growth, and increase profitability.


Press release and photography can be downloaded from www.clariant.com or www.PressReleaseFinder.com



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