This document specifies the characterization and evaluation, including quality assessment and quality control, test items and corresponding methods, packaging and storage of recombinant collagen as starting material for tissue engineered medical products (TEMPs) or other medical devices.
This document is intended to be used for the quality assessment and quality control of recombinant collagen as starting material which may be used for development of recombinant collagen-based scaffold and biomaterials.
This document is not applied for recombinant collagen which will be used as medicine for the treatment of collagen related genetic diseases, such like recombinant collagen VII for the treatment of Epidermolysis bullosa.
Registration number (WIID)
90233
Scope
This document specifies the characterization and evaluation, including quality assessment and quality control, test items and corresponding methods, packaging and storage of recombinant collagen as starting material for tissue engineered medical products (TEMPs) or other medical devices.
This document is intended to be used for the quality assessment and quality control of recombinant collagen as starting material which may be used for development of recombinant collagen-based scaffold and biomaterials.
This document is not applied for recombinant collagen which will be used as medicine for the treatment of collagen related genetic diseases, such like recombinant collagen VII for the treatment of Epidermolysis bullosa.
