| With the application of new materials in orthopedic implantable medical devices, NMPA launched scientific research on the supervision of new materials for medical devices, seeking breakthroughs in management methods, to accelerate the transformation process of new material achievements. By summarizing the major problems in the registration related to orthopedic implantable medical devices made of new materials such as biodegradable magnesium metal and PEEK for additive manufacturing, analyzing the limitations of the existing review methods, and making relevant suggestions to improve the review methods, to enhance the professional and technical level of reviewers in the study of new materials, to help strengthen the applicant's understanding of the safety and effectiveness evaluation of medical devices, so as to adjust the review of ideas, improve the efficiency of the review, and promote the quality of regulatory services. |
