Abstract
The use of bone‐filling material to repair bone defects and fix implanted bone grafts is a developing area in medicine. Investigators can evaluate bone‐filling materials through use of several indices to make comparisons and to determine suitability for application in humans1. However, it is quite difficult to transform their discovery into practical use, because the viability of the studied material might require examination of all aspects of properties. In addition, for a material to become a product, a complete procedure involving a declaration, registration, and approval is necessary. This article introduces the technical indices that the investigators and reporters should provide in their declaration and registration data to meet the relevant standards in China. The indices include physical and chemical properties, biocompatibility, biosecurity, pre‐clinical animal model tests, sterilization and disinfection, product duration, and packaging. Full consideration of all possible indices is crucial to realize the transformation from a designed product to a commercial medical device, which requires effective interaction between clinicians and engineers.
Highlights
Orthopaedic studies have been investigating appropriate materials to fill defects in human bone
Researchers seek out special materials that have mechanical properties that resemble those of bone, and have excellent biocompatibility to enable bone fusion.[1]
The Investigation and Instruction on the registration of CaP/ CaSi-based bone filling materials lists the data that should be submitted during the registration process, and the relevant experiments that should be conducted before registration to demonstrate the viability in regards to every tested property
Summary
Shuo Pan, MD, Bin Liu, BSc , Yue Min, MD, Jia-yi Sun, BSc, Bao Zhai, MD, Xiao-heng Guo, MD. Investigators can evaluate bone-filling materials through use of several indices to make comparisons and to determine suitability for application in humans[1]. It is quite difficult to transform their discovery into practical use, because the viability of the studied material might require examination of all aspects of properties. For a material to become a product, a complete procedure involving a declaration, registration, and approval is necessary. This article introduces the technical indices that the investigators and reporters should provide in their declaration and registration data to meet the relevant standards in China. Full consideration of all possible indices is crucial to realize the transformation from a designed product to a commercial medical device, which requires effective interaction between clinicians and engineers
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