Sep 6, 2018


  • ANVISA rolling out new regulations for custom-made medical devices
  • Requirements will cover commercialization, importing and manufacturing of such devices
  • The new regulations will replace ANVISA’s current “special request” process for custom and patient-specific devices

ANVISA, Brazil’s medical device market regulator, has issued a public consultation to establish new requirements pertaining to custom-made devices.

The new public consultation (link in Portuguese) covers regulations for registration, importation and manufacturing of custom-made and patient-specific devices. The new requirements would replace a current process whereby companies must submit special requests to ANVISA in order to obtain approvals for importing such products. Stakeholders will have 60 days to comment on the consultation following its formal publication on September 5, 2018.

Components of ANVISA regulations for custom-made devices

Elements of the new regulatory regime for custom-made and patient-specific devices include:

  • Device manufacturers and importers must be fully licensed by ANVISA;
  • Manufacturers of Class III and IV devices must have valid Brazilian Good Manufacturing Practice (BGMP) certifications;
  • ANVISA must be notified 60 days prior to importation of a custom-made device;
  • Manufacturers of custom-made devices must provide annual reports to ANVISA detailing all products imported and/or manufactured for sale in Brazil;
  • All ANVISA medical device vigilance and safety requirements are applicable to custom-made devices, as well;
  • Companies must provide traceability labels as part of regulatory compliance.

Brazilian market seeing more widespread use of custom-made devices

According to Luiz Levy, Director of QA/RA at Emergo in São Paulo, ANVISA’s move to set a more formalized regulatory process for custom-made and patient-specific devices reflects rapid technology development such as 3-D printing, which has led to more widespread use of these devices in Brazil.

“With this proposal, ANVISA will create rules to regulate manufacturing, importation and commercialization of customized medical devices already widely used for dental applications and whose use is increasing in other areas such as orthopedics,” says Levy. “With clear rules, the agency is promoting transparency and encouraging companies to invest in these technologies.”

Learn more about Brazilian medical device regulations at Emergo:



  • Stewart Eisenhart