ORBIS Compliance

Understanding the RDC No. 857: Key Updates on the Health Surveillance Inspection Fee

Published /Brazil

RDC No. 857 Overview

RDC No. 857 outlines the procedures for collecting revenue from the Health Surveillance Inspection Fee (TFVS) conducted by the National Health Surveillance Agency (Anvisa).

Key Points of the Update:

  • Monetary Adjustment: The fee adjustment will not exceed the variation of the official inflation index since the last update.
  • GRU Issuance: The Guia de Recolhimento da União (GRU) must be issued in the name of the taxpayer benefiting from the petition, including the National Registry of Legal Entities (CNPJ) number and other relevant data. Changes are not allowed after the issuance of the TFVS.
  • Payment Deadline: The TFVS must be paid within 30 days of the GRU issuance.
  • Transfer of Ownership: When comparing the economic sizes of companies involved in a transfer of ownership, the size of the original company holding the registration will be based on the date of the registration or renewal application. The size of the company requesting the transfer will be based on the date of the transfer application.

Updated Regulatory Impact

The following regulatory impacts have been identified:

  • top_priority: no
  • type_certificate: yes
  • spectrum_bands: no
  • import_changes_hs_codes: no
  • standard_changes: no
  • product_changes: no
  • label_changes: no

You can find the updated values in the link below:

Updated RDC 857 - https://antigo.anvisa.gov.br/documents/10181/6592568/RDC_857_2024_.pdf/3ed0d257-059e-4d3d-b969-52bf0310b340

Regulatory Impact

Impact TypeStatus
Top Priority
Type Certificate
Spectrum Bands
Import Changes (HS Codes)
Standard Changes
Product Changes
Label Changes

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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