The NMPA issued a notice “Information Solicitation on New Materials and Product Performance Evaluation for Biological 3D Printing”. It says domestic and foreign enterprises, scientific research institutes, clinical institutions, etc. are invited to participate on regulations of five types of bio-printed tissue repair medical devices:
- Bio-ceramics
- Ceramics/PEEK composite materials
- Bioactive bone repair materials
- Dental resorbable repair membrane materials
- Aesthetic materials
Download the English version of Tech Guide on Customized Additive Manufactured (3D Printing) Medical Device (Draft)
Read more information on Customize-designed additive manufactured (3D-printed) medical device technical review draft guideline
About the NMPA 3D Bioprinting Notice
The notice lists the following ten areas to input your opinion:
- Technical specification document for functional tissue repair products related to new materials for biological 3D printing
- Research on performance evaluation of biological 3D printing materials
- Research on physical and mechanical performance evaluation of biological 3D printing medical devices
- Bench test verification of biological 3D printing medical devices with new material
- Research on biocompatibility evaluation technology and methods of cell and tissue biocompatibility of new materials and products for bioprinting in vitro
- Construction of animal test evaluation system for new materials and products of biological 3D printing
- Research on clinical effect evaluation indicators of new materials and products for biological 3D printing
- Research on new materials and product production processes for biological 3D printing
- Research on the regeneration performance and evaluation system of biological 3D printing materials
- Research on the performance evaluation of new materials and products in dental environment of biological 3D printing
