ANVISA Approves New Regulations for 3D Printed Custom-Made Devices

Published March 15, 2017/Brazil

ANVISA's New Regulations for Custom-Made Devices

ANVISA has approved a proposal to create new regulations aimed at 3D printed and other custom-made devices. These technologies have become increasingly common across the healthcare sector in the country.

According to ANVISA, the regulator, the collegiate board approved the proposal for new rules concerning custom-made health materials produced via 3D printers. This decision comes in response to the growing use of these products, particularly in orthodontics and dental fields.

Brazil Quick Facts

Regulatory Agency	ANATEL (Agência Nacional de Telecomunicações)
Certification Type	Mandatory
License Validity	Technical compliance certificate: 2 to 3 years
Application Language	Portuguese
Legal License Holder	Required
In-country Testing Requirement	Requires testing

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