OVERVIEW

On October 2019, Anvisa published its formal regulations for custom-made medical devices“RDC 305/2019 “ that went into effect in November 2019.

‘CUSTOM MEDICAL DEVICE’ : ANVISA DEFINITION

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.

MANUFACTURERS AND IMPORTERS ‘CUSTOM MEDICAL DEVICE’ REQUIREMENTS 

In addition to complying with regulatory requirements for medical devices, Anvisa requires manufacturers and/or importer of custom-made devices to perform the following:

• Submit to ANVISA a Request for Consent to manufacture and/or import a custom-made device based on a specific manufacturing plan;
• 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;
• Submit a technical dossier;
• Comply with labeling requirements, including traceability data for implantable devices and package label information;
• Keep records for 15 years for implantable devices and five years for non-implantable devices;
• Assure post-market requirements according to RDC 67/2009 and RDC 23/2012;
• Comply with BGMP for Class I and Class II devices;
• Comply with requirements of Safety and effectiveness under RDC 56/2001.

To learn more about Global Regulatory Partners, services in Brazil by checking the following:

• Brazil Registration Holder (BRH) in-country representation
• ANVISA Medical Device Classification
• ANVISA medical device regulatory strategy 
• ANVISA regulatory intelligence for Brazil Market
• ANVISA medical device consulting for registration and approval in Brazil
• Brazil GMP (BGMP) quality management system compliance.