WHERE/WHO – Manufacture and application regulation for 3D printing

Taiwan announced the “Additive Manufacturing (3D Printing) Medical Equipment Management Guidelines” in January 12, 2016.  The guidelines follow up with the US’s practice, changing the concept that medical materials must be submitted for review with fixed specification.  However, 3D printing is quite different from the traditional manufacturing process.  Consequently, the guidelines clearly define the scope of application of 3D printing medical materials.  Companies can apply for licenses as long as they can provide the specification range, safety instruction, and performance of the 3D printed product.  For instance, the manufacturer can hand in documents to show that the machine has a stable quality and performance when manufacturing 3 to 10 cm medical equipment.  Products exceeding the approved size range can still be manufactured to remain the customizable advantage 3D printing holds, as long as the patient has doctor’s prescription and the 3D printing medical devices are produced by a licensed manufacturer.

The biggest consideration for medical personnel is whether the use of such 3D printing software, surgical guides, implants and other medical materials today has great concerns in the legal field.  In the past, we have been communicating with the medical team of the Ministry of Health and Welfare for many times since 2015. We are also very grateful for the guidance of the administration.  In 2017, the Ministry of Health and Welfare already had set up guidance for 3D printing surgical planning and materials for implants and surgical guides.  There are even regulations for customized medical devices.  We suggest that those who have concerns can first look at the relevant regulations of 3D printing medical equipment, or contact our alliance for consultation.  Currently, we still expect to provide legal materials and models, which are produced by licensed and ISO and GMP certified manufacturers, for doctors to perform surgical applications.  This is the approach that is best consistent with the current medical device regulations.  However, doctors using non-FDA or TFDA-approved 3D simulation software by themselves is not clinically legal.