RDC Compliance Deadlines for Manufacturers Based on Device Risk Ratings

Published January 10, 2022/Brazil

RDC Compliance Deadlines for Manufacturers

RDC has established compliance deadlines for manufacturers based on the risk rating (RDC 185/2001) of their devices:

2.5 years for Class IV devices
3 years for Class III devices
4 years for Class II devices
6 years for Class I devices

Note: Unique Device Identification (UDI) requirements are applicable for medical devices (including In Vitro Diagnostics products) approved by ANVISA, except for bespoke medical devices and those in clinical investigation.

The RDC also explains that ANVISA will create a UDI database to validate, consolidate, process, and make all information available to the public.

Brazil Quick Facts

Regulatory Agency	ANATEL (Agência Nacional de Telecomunicações)
Certification Type	Mandatory
License Validity	Technical compliance certificate: 2 to 3 years
Application Language	Portuguese
Legal License Holder	Required
In-country Testing Requirement	Requires testing

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