DINCH Medical Device Certification
DINCH Medical Device Certification
Zhongshan R&D Center | Engineer Xiaona Zheng
According to the China Medical Device Association, there are slightly over 1,000 companies engaged in the production of disposable medical plastics in Mainland China. Medical plastic raw materials are subject to stringent requirements and must undergo national regulatory oversight, including clinical trial supervision for medical devices and regular inspections. Products that fail to meet the required standards may face market rejection or mandatory recalls.
Medical Device Classification Overview
Medical devices are classified into Class I, Class II, and Class III categories. According to the Classification Directory of Medical Devices:
Class I and Class II: These devices are generally disposable and relatively simple to operate, with their safety and effectiveness ensured through regulatory management. For medical devices that do not pose direct risks to human safety, relevant product standards and testing reports are typically required. For products already on the market, substantial equivalence application documentation is necessary for registration.
Class III: These medical devices are subject to rigorous pre-market review and post market supervision. In addition to the documentation mentioned above, ongoing post market monitoring is required, including accident tracking, clinical trials, and clinical research reports.
UPC DINCH Compliance Application
DINCH produced by UPC Technology has been successfully applied in Class III medical devices, and these DINCH products have passed biocompatibility assessments in accordance with ISO 10993. Polyvinyl chloride (PVC) plasticized with 1,2 cyclohexane dicarboxylic acid diisononyl ester has been used in Baine Company’s hemodialysis tubing sets. The product manufactured using UniHydro® DINCH (UN899) has passed safety performance evaluations under GB/T 16886 and ISO 10993 standards, complies with regulatory requirements in Mainland China and the European Union, and is supported by comprehensive biological toxicity test data.
Numerous studies published in Mainland China have proposed replacing DEHP with DINCH to reduce potential harm to human health. As noted in Literature 1, the patent titled “A Method for the Preparation of a Needle Long Catheter” proposes substituting previously used phthalate plasticizers with DINCH, thereby significantly reducing the potential toxicity and health risks associated with plasticizers. Document 2, the patent titled “A Type of Medical PVC Granule Material”, describes the use of DINCH as a replacement for DEHP, eliminating the potential risks associated with DEHP migration in PVC and reducing concerns related to DEHP’s potential carcinogenic effects.
From a human health perspective, the selection of safe, non-toxic, and low migration plasticizers represents a key development trend for the medical materials industry in the future.
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