[Discussion on Key Attention in Technical Review for Additive Manufacturing Acetabular Reconstruction Implantable Device].
Zhongguo Yi Liao Qi Xie Za Zhi
; 46(6): 659-663, 2022 Nov 30.
Article
em Zh
| MEDLINE
| ID: mdl-36597395
ABSTRACT
With the development of additive manufacturing, the advantages of this type implant devices in the treatment of acetabular defects and reconstruction are becoming more and more prominent. The number of registration and declaration of such products is increasing day by day. According to the relevant requirements of the National Medical Products Administration for registration and application documents, combined with the characteristics of acetabular reconstruction implant products made of additive manufacturing, this study analyzes and summarizes the relevant requirements on raw material control, product performance research, product manufacturing, clinical evaluation, et al. We should pay more attention to in the registration and application materials submitted by the applicant. Provide opinions and suggestions for the next registration applicant to standardize product R&D and registration application documents, in order to help them optimize product R&D process, improve product quality and registration application efficiency.
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Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Próteses e Implantes
/
Comércio
Idioma:
Zh
Ano de publicação:
2022
Tipo de documento:
Article