Brazil – Brazil’s ANVISA approves formal regulations for custom-made medical devices

Brazilian medical device market regulator ANVISA has officially approved new regulations pertaining to registration and commercialization of custom-made devices in the country.

The new regulation, RDC 305/2019 (link in Portuguese), was first announced in 2018 and then revised earlier this year, according to reports from Emergo by UL consultants in Brazil. The final version of the regulation retains distinctions between custom-madeadaptable and patient-specific devices, and lays out ANVISA registration requirements for each of these device types.

The new regulation will go into effect 30 days following publication in the Brazilian government’s Official Diary.

ANVISA registration for custom-made medical devices

RDC 305/2019 defines “custom-made device” as any device intended for use by a specific patient or user, and that has been manufactured for that patient or user based on a healthcare provider’s prescription that includes specific device design features. Besides standard Brazilian market registration requirements, custom-made devices must also undergo the following process:

  • For all classes of custom-made devices, manufacturers and importers must first submit to ANVISA a Request for Consent to manufacture and/or import a custom-made device based on a specific manufacturing plan.
  • Second, firms must submit a Request for Consent to notify Brazilian regulators of the manufacture and/or importing of each particular custom-mad device.
  • Manufacturers and importers of Class III and Class IV custom-made devices must implement and maintain Brazilian Good Manufacturing Practice (BGMP) quality management system certification for production sites, or have renewal protocols appropriate to their devices’ risk classifications…