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July 13, 2017

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.

 
According to Anvisa´s Medical Devices Office interpretation, the non-existence of specific rules for customized prostheses does not exclude the applicability of the main regulations and requirements for medical devices and a prior authorization to manufacture and commercialize such materials is required. Conversely, non-compliance with such requirements may result in serious consequences for the stakeholders involved.
 
It is worth mentioning  ANVISA’s President Order 16/2017,that approved a proposal  to specifically regulate  this matter.
 
Considering the potential growth of such manufacturing method in the Brazilian market, our team is actively advising stakeholders about  the procedure nowadays imposed for 3D printing prostheses authorizations.
 
Access the original news within ANVISA’s website by clicking here and here. For further clarifications regarding the authorization procedure and the proposal to regulate this issue, do not hesitate to contact us through e-mail bio@kasznarleonardos.com
 
 
 
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