Published /Brazil
This RDC revokes the old RDC 25/2001. The review of the former RDC was carried out with the aim of covering and revising the regulatory requirements and updating and harmonizing the concept of reform used internationally.
RDC579/2021 defines the requirements for the importation, commercialization, and donation of used or refurbished medical devices intended for use in Brazil, applicable to medical equipment and in vitro diagnostic instruments.
| 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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