| Objective To review the standard, guideline and technical data of the coating for artificial hip joint prosthesis. Methods Recent literature concerning registration for the coating of artificial hip joint prosthesis was reviewed and analyzed. Results The aspects of the evaluation for coating of the artificial hip joint prosthesis include chemical composition, morphology, mechanical properties, environmental stability, corrosion resistance, biocompatibility and so on. Conclusion The main difficulty in registration is how to prepare the research data of the product, so the manufacturers need to enhance their basic research ability and work out a scientific technique routing which could ensure the safety and effectiveness of the product, also help to set up the supportive documents to medical device registration. |
