3D Printing – ANVISA orders shutdown of production line of customized prostheses

The operation confirmed that prostheses were manufactured on demand of two companies, which may be subject to penalties including a fine  that may reach the maximum amount of R$ 1.5 million. This fine can also be cumulative with shutdown and cancellation of permits and licenses to operate. As a follow-up, after the investigation  of one of the companies, on  07/11/2017, ANVISA seized 60 illegal prostheses that lacked the mandatory documentation concerning its traceability. Moreover, there is evidence that some public documents could have been altered.

Despite Senai Joinville´s reputation with research related with 3D printing, also known as “additive manufacture”, the current episode demonstrates that regulatory compliance should be carefully dealt by research centers, even with the absence of specific regulation.