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European Certification
With our total commitment to quality and safety, WCH have been granted the Oeko-Tex Standard 100 certificate in January 2008. WCH is the first company in the packing industry to get the Oeko-Tex Standard 100 certificate. The Oeko-Tex Standard 100 was introduced in 1992 to make companies in the textile industry more sensitive to the need for a responsible approach to problematic substances in the environment. The Oeko-Tex Standard 100 excludes harmful substances or controls their use. WCH has also registered the facility and stockinette product with the Food and Drug Administration (FDA) in the United States of America under the classification of Physical Medicine Devices - Prosthetic and Orthotic Accessory and it is a Class 1 device (General Controls).
American Certification
WCH is registered with United States Food and Drug Administration (FDA) --- Center for Devices and Radiological Health (CDRH). CDRH is responsible for regulating firms who manufacture, repackage, relabel, an/or import medical devices sold in the United States. The FDA has established classifications for approximately 1,700 different generic types of devices and grouped them into 166 medical specialties referred to as panels. Each of these generic types of devices is assigned to one of three regulatory classes based on the level of control necessary to assure the safety and effectiveness of the device. All classes of devices are subject to General Controls. General Controls are the baseline requirements of the Food, Drug and Cosmetics (FD&C) Act that apply to all medical devices, Class I, II, and III. In addition, classification is risk based, that is, the risk the device poses to the patient and/or the user is a major factor in the class itis assiged. Class I includes devices with the lowest risk and class III includes those with the greatest risk. WCH stockinette is classified as Class I General Controls With Exemptions and the product code is ITG.
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