Oct 3, 2019

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-made, adaptable 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.

Adaptable medical devices: Current ANVISA requirements remain in place

A mass-produced device featuring adjustments, fittings or modifications based on validated instructions from the manufacturer in order to accommodate a specific patient’s anatomic-physiological characteristics qualifies as an “adaptable medical device,” according to the new ANVISA regulation.

For such devices, ANVISA registration requirements are already in place and will remain so under RDC 305/2019.

Patient-specific medical devices: Transition period

ANVISA considers a device that has been modified to be compatible to a specific patient’s anatomy via anatomical reference sizing techniques or anatomical imaging methods to be a “patient-specific device.” Such devices may be manufactured in batches using valid and repeatable processes for which the manufacturer bears responsibility, according to RDC 305/2019.

Manufacturers and importers of these devices must submit Requests for Consent to ANVISA the same way custom-made device manufacturers and importers must do. However, ANVISA is granting a 24-month transition period for patient-specific devices already marketed in Brazil to move into full registration compliance.

Related documentation requirements

ANVISA identifies several documentation and process requirements manufacturers and importers of devices under the scope of RDC 305/2019 should also meet:

  • Technical dossiers
  • Labeling requirements, including traceability data for implantable devices and package label information
  • Record keeping timelines (15 years for implantable devices and five years for non-implantable products)
  • Post-market requirements according to RDC 67/2009 and RDC 23/2012
  • BGMP compliance for Class I and Class II devices
  • Safety and effectiveness compliance requirements under RDC 56/2001

Bottom line: Faster patient access to custom-made medical devices

Luiz Levy, Director of RA/QA at Emergo by UL in São Paulo, says RDC 305/2019 formalizes Brazilian market entry requirements for an important type of medical devices as the technology to develop these devices improves.

“ANVISA has also established rules for patient-specific devices, which as a consequence will certainly help devices with these features reach patients and end-users faster in Brazil,” Levy explains.

“However, it’s important for manufacturers to understand and comply with the new rules for custom-made devices, such as the need to have BGMP certification for Class III and Class IV device manufacturing sites, as well as required proof of valid ANVISA registration for devices produced on a commercial scale in the same factory, and with the same risk classification and indications for use.”

Learn more about Brazilian medical device regulations at Emergo by UL:

  • Brazil ANVISA medical device registration and approval consulting
  • Brazil GMP (BGMP) quality management system compliance support
  • ANVISA medical device vigilance reporting
  • Whitepaper: Medical device registration in Brazil
  • ANVISA medical device regulations resource page