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CFDA Approval Challenges the Use of 3D Printers in the Medical Field

5. September 2017

Swiss scientists have succeeded in printing a heart for the first time, which in form, size and function is very close to the human heart. This is a great progression in 3D printing technology. The technology is one challenge, but also the CFDA license to enter the Chinese market can be a challenge.
The use of 3D printers for the medical field in the Chinese market is not yet widespread. This brings a big potential for the development and expansion for companies. Currently, the artificial heart is still in the testing phase since it has proven only 3,000 heart beats, which corresponds to a period of 30 to 45 minutes.
Although it cannot yet be implanted into the human body this development is a great progression. 3D printers are already widely used in the field of precision medicine. For example, 3D prints are used as implants, as complex surgical instruments, as hearing aid shells as well as in orthopedics and dentistry area.
In order to bring the 3D printing technology for medical applications to the Chinese market, such products have to comply with the Chinese terms and regulations. The medical devicesfrom the 3D printer cannot be sold without the corresponding approval, for China that would be the CFDA Approval.
In order to exploit the market potential for 3D printing technology, the producers have to go through the CFDA registration. For a smooth application, the manufacturers should work with a competent consulting company to save costs and complete the process as soon as possible.
You can find further information about our services for CFDA registration on our website.
It is expected that there will be more announcements, revisions and changes to the CFDA regulations in the near future. You will find updated information in our News Section on our website, where we will keep you informed regarding official announcements.
Please do not hesitate to call (UK: +44 2071931135, Rest of Europe: +49 69 2713769150, US: +1 773 6542673) or e-mail and we will be happy to answer questions.

MPR Author

About the author: Julian Busch is founder and managing director of MPR China Certification GmbH
Publisher: MPR China Certification GmbH

Tel.: +49 69 271 37 69 150