4 services found
Proregulations services
Proregulations - Keep Toxic Substances Away: U.S. Food Contact Materials Compliance
U.S. Food Contact Materials Compliance: Food contact materials (FCMs) are regulated in the US to ensure that they do not pose a risk to human health. There are three main steps to be FDA compliant. The first step involves the established FCMs that follow existing FDA regulations. The second step involves applying FDA authorization for new food contact substances by submitting a Food Contact Notification (FCN) and/or Threshold of Regulation (ToR). The final step involves using the No Migration Exemption, which allows a company to argue that there is no need to notify the substance.
Proregulations - U.S. FDA Medical Device Establishment Registration and Listing
U.S. FDA Medical Device Establishment Registration and Listing: DA has divided into two groups of establishments which is domestic and foreign establishments. In general, if you are a manufacturer of medical device must register and list the device. However, except for initial importer do not need to register but also the companies require listing device to the FDA.
The initial importer is who responsible for furthers the marketing of a device from a foreign manufacturer to the final distributor for sale device to the ultimate consumer or user, but does not repackage, or otherwise change the container, wrapper, or labeling of the device or device package.
FDA Medical Device Registration
FDA Medical Device Registration: A medical device is difficult to classify since new technology and intended use, our regulatory consulting can help you to classify and determine the device in the united states, and we can process with your submission with FDA. Prepare the correct FDA submission and proper U.S. FDA classification of your device is extremely important to avoiding regulatory delays and costs, so let us help you to get your products cleared for sale into U.S. market as quickly as possible. If you need help or have a question, please feel free to contact us for more details.
Medical Device Packaging Testing
Medical device packaging testing is to verify and test the performance of packaging in a laboratory. Registration data for medical and medical products are required to include the results of packaging studies to demonstrate the safety and effectiveness of the contents after delivery, transportation, storage and until use.
