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QMS
  • Welcome to your QMS
  • Quality Manual
  • Procedures
    • GP-001 Control of documents
    • GP-002 Quality planning
    • GP-003 Audits
    • GP-004 Vigilance system
    • GP-005 Human Resources and Training
    • GP-006 Non-conformity, Corrective and Preventive actions
    • GP-007 Post-market surveillance
    • GP-008 Product requirements
    • GP-009 Sales
    • GP-010 Purchases and suppliers evaluation
    • GP-011 Provision of service
    • GP-012 Design, Redesign and Development
    • GP-013 Risk management
    • GP-014 Feedback and complaints
    • GP-015 Clinical evaluation
    • GP-016 Traceability and identification
    • GP-017 Technical assistance service
    • GP-018 Infrastructure and facilities
    • GP-019 Software validation plan
    • GP-020 QMS Data analysis
    • GP-021 Communications
    • GP-022 Document translation
    • GP-023 Change control management
    • GP-024 Cybersecurity
    • GP-025 Corporate Governance
    • GP-026 Product requirements for US market
    • GP-027 Product requirements for UK market
    • GP-028 Product requirements for the Brazilian market
    • GP-050 Data Protection
    • GP-051 Security violations
    • GP-052 Data Privacy Impact Assessment (DPIA)
    • GP-100 Business Continuity (BCP) and Disaster Recovery plans (DRP)
    • GP-101 Information security
    • GP-200 Remote Data Acquisition in Clinical Investigations
  • Records
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  • Licenses and accreditations
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  • Procedures
  • GP-028 Product requirements for the Brazilian market

GP-028 Product requirements for the Brazilian market

Purpose​

This procedure establishes the process and requirements for introducing and maintaining software as a medical device in the Brazilian market. It ensures compliance with the standards and regulations set forth by ANVISA (Agência Nacional de Vigilância Sanitária) and defines guidelines for conducting post-market activities.

Scope​

This procedure applies to all activities involved in registering, labelling, and marketing our software as a medical device in Brazil. It also encompasses post-market responsibilities, including vigilance, adverse event reporting, and ongoing regulatory compliance.

Definitions​

  • ANVISA: Agência Nacional de Vigilância Sanitária
  • IFU: Instructions For Use

Responsibilities​

JD-005​

Ensure legal and regulatory compliance of our medical devices, specifically those registered in Brazil.

JD-003​

Organize and manage development resources to achieve compliance with requirements.

JD-004​

Ensures compliance with Brazil-specific requirements and oversees the registration process.

JD-001​

Approve the procedure and provide the required resources to perform the activities described in it.

Inputs​

  • Collegiate board resolution - RDC No. 751, of September 15, 2022
  • Collegiate board resolution - RDC No. 657, of March 24, 2022
  • Collegiate board resolution - RDC No. 546, of August 30, 2021
  • Brazilian Law 6360/76

Outputs​

  • Contract with an authorised representative in Brazil
  • Medical device registration approval from ANVISA
  • Technical dossier, including reviewed label and IFU to comply with applicable requirements, and declaration of conformity

Development​

Pre-market activities​

This section details the steps we need to follow to comply with the applicable requirements for placing our device in the Brazilian market.

Authorised representative designation​

Since we are a manufacturer based outside Brazil, the first activity is to search for an authorised representative based in Brazil to support us in the registration process and to act as the primary contact with ANVISA, and, once the authorised representative is selected, to have a contract in place to detail the mutual responsibilities.

Technical documentation preparation​

In order to understand the regulatory requirements applicable to our device, we first shall define the risk classification of the device according to the rules set out in the Collegiate board resolution - RDC No. 751, of September 15, 2022.

The level of details of the technical documentation to submit to ANVISA is based on the risk classification of the device.

The appointed authorised representative supports us with the preparation of the so called Technical dossier to be submitted to ANVISA.

The main changes to be applied to the technical documentation to comply with specific requirements are the following:

  • Review the label and IFU of the device to include the information (name and address) about the authorised representative in Brazil
  • Review the label and IFU of the device to include the information about the technical responsible person in Brazil
  • Review the label and IFU of the device to include the ANVISA registration number (this information will be completed once we receive the ANVISA approval)
  • Create a declaration of conformity to ensure compliance with applicable regulations.

Once the required documents are prepared, we will share them with our authorised representative who is responsible for their submission to ANVISA.

Post-market activities​

This section explains which are the required activities during the post-commercialisation phase to ensure compliance with applicable regulatory requirements and to ensure safety and performance of the device available in the market.

Notification of adverse events and advisory notice​

We document, investigate, address feedback and customer complaints according to the procedure GP-004 Vigilance system, GP-014 Feedback and complaints GP-006 Non-conformity, Corrective and Preventive actions.

The initiation and the documentation of advisory notices is performed according to the procedure SP-004-001 Product withdrawal.

Information about adverse events occurred with the use of the device in the Brazilian market (including information on the investigations and actions taken to solve the issues) and initiation of advisory notices will be communicated to our authorised representative. Adverse events and advisory notices will be notified to ANVISA according to the timelines described in the following sections.

Timelines for notification of adverse events​
  • Within 72 hours in case of death, public health threat or counterfeiting;
  • Within 10 days in case of serious adverse events not involving death and non-serious adverse events, the re-occurrence of which has the potential to cause a serious adverse event to a patient, user, or other person;
  • Within 30 days in case of a malfunction that could lead to a serious adverse event; within 10 days in case of death, public health threat or counterfeiting occurred in other countries and associated with health products registered in Brazil.
Timelines for notification of advisory notice​

Advisory notices shall be notified to ANVISA within 5 calendar days from the decision to start the field action.

Notification of changes​

Changes to the medical device already approved by regulatory bodies are documented, analysed and implemented according to the procedures GP-012 Design, Redesign and Development and GP-023 Change control management.

According to the requirements set out in the Brazilian Law 6360/76, Article 13, we shall notify ANVISA about changes involving medical device already approved by ANVISA when the changes are classified as significant. For this type of changes, we shall submit the revised technical documentation for a new approval.

Changes that shall be submitted are those which affect:

  • Features of safety and effectiveness, including measures to communicate information (ex. residual risk)
  • Identification of the device or its manufacturer or manufacturing site
  • Indication for use, including its purpose, patient type (adult, pediatric, newborn) or environment to be used (domestic, hospital, ambulance, etc.)
  • Device classification
  • Technical specification of the device, including composition and other operational/technical/physical features
  • Manufacturing method.

Significant changes to the medical device already approved and placed in the Brazilian market will be also communicated to our authorised representative since the authorised representative has responsibilities related to post-market surveillance.

Associated documents​

  • GP-004 Vigilance system
  • SP-004-001 Product withdrawal
  • GP-014 Feedback and complaints
  • GP-006 Non-conformity, Corrective and Preventive actions
  • GP-012 Design, Redesign and Development
  • GP-023 Change control management
  • T-001-002 Manufacturer declaration of conformity for Brazil
  • T-001-008 Legit.Health Plus label for Brazil

Signature meaning

The signatures for the approval process of this document can be found in the verified commits at the repository for the QMS. As a reference, the team members who are expected to participate in this document and their roles in the approval process, as defined in Annex I Responsibility Matrix of the GP-001, are:

  • Author: Team members involved
  • Reviewer: JD-003, JD-004
  • Approver: JD-001
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GP-027 Product requirements for UK market
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GP-050 Data Protection
  • Purpose
  • Scope
  • Definitions
  • Responsibilities
    • JD-005
    • JD-003
    • JD-004
    • JD-001
  • Inputs
  • Outputs
  • Development
    • Pre-market activities
      • Authorised representative designation
      • Technical documentation preparation
    • Post-market activities
      • Notification of adverse events and advisory notice
        • Timelines for notification of adverse events
        • Timelines for notification of advisory notice
      • Notification of changes
  • Associated documents
All the information contained in this QMS is confidential. The recipient agrees not to transmit or reproduce the information, neither by himself nor by third parties, through whichever means, without obtaining the prior written permission of Legit.Health (AI LABS GROUP S.L.)