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2018 3D Printing Medical Application Highlights (1)


Thanks to advantages such as high precision, solidity of finished products, and the ability to copy complex geometric models, 3D printing technology is increasingly used in more and more industries. The medical and surgical center’s demand for 3D printing accounts for two-thirds of the market share.

According to Allied Market Research data report, the 3D printing medical application market was 579 million US dollar and the market will be expected to reach 2.36 billion US dollar in 2020, with an average 26.6% annual increase.


For the summary of the CFDA 3D printing device draft guideline, please click Here. For the complete English version of the guideline, please email

China Med Device, LLC and CABA held a regulatory event on 3D printing with CFDA representatives in 2017 December. For the presentation from the CFDA director, please also email us.


Medical Accessary

3D Print Osteotomy Assisting Knee Replacement Surgery

At the beginning of this year, Huizhou First People’s Hospital adopted WRIGHT 3D printing technology to customize osteotomy tools and successfully performed a knee replacement operation. First, they need to transfer the patient’s CT data to the medical 3D printing company to design the product according to some key parameters, such as the degree of osteotomy and the degree of corrective deformity, and calculate the patient bone shape by computer and make 3D-print osteotomy tools with high-density nylon material

It was the fact that the operation time is reduced about 40 minutes compared with the average time of similar operations in the past with the 3D osteotomy tools, and the knee prosthesis was also highly fitting with the true bone of the patient. Only one day after surgery, the patient could try to walk.


Kidney Transplantation Using 3D Print Model

Recently, a 3D printed kidney surgery model helped surgeons at Belfast Hospital in Northern Ireland to complete a very complex surgery. Pauline Fenton, a 22-year-old female from Belfast needed kidney transplantation but there was a potential cancerous cyst on the kidney that his father would donate. In this case, the doctor must ensure accurate and complete removal of the cyst to obtain maximum healthy transplant tissue.

Given the complexity of the transplant preparation, the surgeon worked with local medical 3D printing company axial3D. The axial3D used CT scan imaging to construct a precise 1:1 model of William Fenton kidney. The model was then 3D printed in an axial3D laboratory using adhesive spray technology. This insight cannot be achieved with standard preoperative imaging. The team responsible for this operation said that the kidney model is beneficial for planning the best procedure of their surgery. In the end, cyst is removed and kidney transplantation was successful, and Pauline also regained her new life.


For regulatory and commercialization services on China 3D printing market, please email


About China Med Device, LLC  

China Med Device, LLC provides turn-key solutions for western medical device/IVD companies to enter China with regulation and commercialization services. Our CFDA regulatory services cover strategy, premarket submission, clinical evaluation, CRO, QA and post market compliance. We are experienced in handling innovation approvals and priority reviews. Our commercial services cover market assessment research, reimbursement, partnership, distribution qualification and management. We have offices in Beijing, Suzhou and Boston. Our management team has 100+ years of combined experience in medical device and IVD and has been involved with 1,000+ CFDA certificates and 200+ companies’ success.  

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