Analyze the standard and quality control of 3D printing medical products
In China, the policies related to 3D printing medical applications, doctors and 3D printing circles are very loud, lacking relevant approval and certification system programs, leading to advanced technology, doctors want to use, patients want to use, but can not be used due to policy and regulations. China's medical laws and regulations lag far behind the development of technology. Recently, Wang Chunren of the Biomaterials Laboratory of China Food and Drug Control Research Institute published a "3D Printing Medical Device Product, Standard and Quality Control" at the 2017 Vascular Innovation Forum. Xiaobian note. The content is as follows: 1. Introduction to 3D printing medical technology 1 material Metal materials, polymer materials, ceramic materials, cells, and the like. Natural biomaterials derived from animal and plant tissues are mainly collagen, glycosaminoglycan, chitosan, alginate, fibrin, and the like. The degradable material is a synthetic biomaterial, and mainly has a poly-α-hydroxy acid including polylactic acid, polyglycolic acid, poly-ε-caprolactone polyanhydride, polyphosphoric nitrogen, polyamino acid and the like. 2 applications Surgical instruments, implanted instruments, living cells, tissues and organs. 3. 3D printing features Solid structure, porous structure and solid structure plus porous structure. The void size, void ratio, and porous strength of the porous structure can be manufactured according to the design. In particular, a penetrating porous structure. 4.3D printing medical device status The United States Food and Drug Administration (FDA) has published the Dietary Supplement Health and Education Act (DSHEA), which provides for dietary supplements. A product (other than tobacco) intended to supplement the diet may contain one or more of the following dietary ingredients: A vitamin, a mineral, an herb (herbal) or other plant, an amino acid, a food component used to increase the total daily intake to supplement the diet, or a concentrate, metabolite, component, extract or combination of the above ingredients, etc. It also includes approved new drugs, vitamins or biologics that have been marketed as dietary supplements or food products before they are approved, issued or licensed. The DSHEA defines dietary supplements as their composition and labeling requirements: the product form may be pill, capsule, tablet or liquid; The product shall not be used as a substitute for ordinary foods or as an exclusive dietary item. The product shall be labeled as a "dietary supplement". Dietary Supplements,Arachidonic Acid Powder,Kava Root Powder,Kava Root Extract Powder Xi'an Double H Health Technology Co., Ltd , https://www.xadoubleh.com
