Would an imported NMPA dossier need to identify a foreign registration holder separately from the Chinese agent?
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Would an imported NMPA dossier need to identify a foreign registration holder separately from the Chinese agent?
What an NMPA dossier must identify is set by that authority's rules, and the dossier for a finished product is prepared by the party that files it.
C-POLAR supplies a materials technology. The published position is that every commercial NanoFlashing™ product is made by a manufacturing partner, in their facility, in their format. The published Terms of Use state: “The manufacturer and seller of a finished product are responsible for its design, manufacture, labeling, instructions, claims, sale, and warranty, except for a responsibility C-POLAR expressly accepts in a Separate Agreement.” They also state: “Unless a Separate Agreement expressly says otherwise, C-POLAR is not the manufacturer or seller of a finished product merely because that product uses or refers to C-POLAR technology.” C-POLAR has published no classification or certificate for China. A locally converted material and an imported finished product are different articles, and a change of material or of maker produces a different article. The published Terms of Use state: “A test of C-POLAR material, a component, or a prototype does not establish the performance of a finished product that incorporates it.” The published position is that development runs configuration by configuration, and each partner controls what is said about the work. General enquiries go to [email protected].
Source: C-POLAR — About, https://cpolar.tech/about/; C-POLAR — Terms of Use, https://cpolar.tech/terms/.
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