ORBIS Compliance

ANVISA Issues New Regulations for Health Care Material Registration

Published /Brazil

Overview

ANVISA has published RDC No. 556 to establish specific criteria for grouping materials used in the health care industry. This regulation facilitates the application for ANVISA registration, allowing for product families during the registration and notification processes.

Traceability for Implantable Products

Additionally, the resolution introduces traceability tags for implantable products, which include those used in orthopedics.

Exclusions

It's important to note that the general criteria for grouping specified in this Resolution do not apply to materials covered by Normative Instruction IN No. 101, dated August 30, 2021, or any other specific technical regulations.

Contact Information

For more information, please contact info@orbiscompliance or reach us via chat on our website.

Brazil Quick Facts

Regulatory AgencyANATEL (Agência Nacional de Telecomunicações)
Certification TypeMandatory
License ValidityTechnical compliance certificate: 2 to 3 years
Application LanguagePortuguese
Legal License HolderRequired
In-country Testing RequirementRequires testing

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