ORBIS Compliance

ANVISA Suspends Deadlines for Regulatory Procedures

Published /Brazil

On March 23rd, 2020, the National Health Surveillance Agency from Brazil (ANVISA) announced Resolution - RDC No. 355/2020, temporarily suspending deadlines for ANVISA procedures. This includes the review of timelines for medical device and in-vitro diagnostics (IVD) petitions, as well as manufacturers' deadlines for document submission. However, deadlines related to maintenance processes and field safety actions remain unchanged as part of this resolution, which is valid for 120 days from its issuance.

Exceptions to Resolution:

  1. Records of active pharmaceutical ingredients, medicines, biological products, and cannabis products (Wording given by RDC No. 376, of April 20, 2020).
  2. Changes after the registration of medicines and biological products.
  3. Certification of bioequivalence centers.
  4. Qualification of pharmaceutical equivalence centers.
  5. Consent and modification in clinical trials of medicines and biological products.

For more information, please contact info@orbiscompliance.com - mailto:info@orbiscompliance.com or (408) 465-7331.

Based on the IFT 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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