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Brazil’s ANVISA Developing Regulations for Custom-made Medical Devices



  • Brazilian medical device regulator ANVISA has approved a proposal to create a new regulation specifically addressing 3D and custom-made medical devices and technologies.
  • Use of 3D printers to produce custom-made devices is increasing in Brazil, but no regulations targeting these products yet exists in the country.

Brazil ANVISA regulations for 3D and custom made medical devicesBrazilian medical device regulators at ANVISA have approved a proposal to create new regulations targeting 3D and other custom-made devices as such technologies become more common across the country’s heathcare sector.

According to Emergo consultants attending a recent meeting of ANVISA’s collegiate board, the regulator approved the proposal for new rules for custom-made health materials produced via 3D printers to address increasing use of such products particularly in dental an orthodontic settings.

“This regulation will define rules for registration and commercialization of these technologies, which is necessary as these types of devices will become more common,” says Luiz Levy, Director of RA/QA at Emergo’s Brasilia office.

“Currently there are no regulations for these device types in terms of ANVISA registration rules or safety assurances.”

For more information on Brazil’s existing system for medicla device registration, download our regulatory process chart and watch our video overview.

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