The standards for Class I medical device registration with ANVISA in Brazil are primarily defined by ANVISA regulations and international standards that ensure the safety, quality, and performance of the device. Since Class I devices are considered low-risk, the standards are generally less stringent than for higher-risk devices. However, they still require manufacturers to demonstrate compliance with certain criteria.

Here are the key standards and requirements for Class I medical device registration with ANVISA in Brazil:

1. ANVISA Regulations:

1. RDC 185/2001:

   • This is the primary regulation for medical devices in Brazil, detailing the requirements for classification, registration, and monitoring of medical devices.
   • It establishes the basic framework for Class I medical devices and includes general guidelines for submitting a registration application, labeling requirements, and post-market surveillance.

2. RDC 16/2013:

   • RDC 16 defines the criteria for medical device classification. It specifically outlines the risk-based classification system for devices and provides the criteria for Class I devices.
   • It is important to review this regulation to confirm that the device qualifies for Class I classification based on its intended use, risk profile, and invasiveness.

3. RDC 67/2009:

   • This regulation pertains to the requirements for product labeling, ensuring that all labeling information is clear, accurate, and conforms to Brazilian guidelines.
   • For Class I devices, it outlines the need for labeling that includes the manufacturer’s details, intended use, batch or lot number, and warnings or precautions.

2. International Standards:

1. ISO 13485:2016 (Quality Management Systems):

   • While this is not specific to Class I devices, ISO 13485 outlines the requirements for a Quality Management System (QMS) for medical device manufacturers.
   • Compliance with ISO 13485 helps ensure that the manufacturer has established effective procedures for product design, manufacturing, testing, and quality control, even for low-risk Class I devices.
   • If the device is manufactured outside of Brazil, ISO 13485 certification may be required to demonstrate that the manufacturer adheres to proper quality management practices.

2. ISO 14971:2019 (Risk Management):

   • ISO 14971 is the international standard for risk management of medical devices. It provides guidelines for identifying hazards, assessing risks, and implementing controls to reduce risks to an acceptable level.
   • Although Class I devices are low-risk, manufacturers must still perform a risk analysis and document how risks are controlled, which is essential for the registration process.

3. ISO 10993 (Biocompatibility):

   • If the Class I device comes into contact with the human body, biocompatibility testing according to ISO 10993 is often required. This standard ensures that materials used in the device do not cause harm or adverse reactions when in contact with biological tissues.
   • For non-invasive devices, biocompatibility may not be required, but it depends on the nature of the device and its materials.

4. IEC 60601 (Electrical Safety and Performance):

   • If the device includes electrical components (e.g., diagnostic devices, thermometers, etc.), IEC 60601 standards for electrical safety and performance may apply.
   • These standards ensure that electrical medical devices meet safety requirements for both patient and user protection.

3. ANVISA’s e-PL System:

• All submissions for Class I medical device registration must be done through ANVISA’s e-PL system (electronic Product Licensing System).
• The system requires that manufacturers or their local representative upload all necessary documents, including compliance with the above standards, as part of the registration process.

4. Local Regulatory Considerations:

1. Portuguese Language Requirements:

   • All documents submitted to ANVISA must be in Portuguese (including labels, instructions for use, and technical documentation). For foreign manufacturers, this typically means translating all relevant documents.

2. Good Manufacturing Practices (GMP):

   • If the device is manufactured outside Brazil, you may need to show evidence of compliance with Good Manufacturing Practices (GMP). This is generally demonstrated through ISO 13485 certification or an equivalent standard.
   • Local representatives in Brazil (for foreign manufacturers) must also ensure compliance with GMP standards and may need to submit documentation confirming that the manufacturing process adheres to these guidelines.

5. Labeling and Packaging Standards:

• RDC 67/2009 also outlines the specific labeling requirements for medical devices in Brazil, ensuring that the product information is accurate, clear, and in compliance with Brazilian regulations.
  • Labeling must include information such as:
    • Manufacturer details.
    • Intended use.
    • Any warnings, contraindications, and safety information.
    • Batch/lot number.
    • Expiry date (if applicable).
    • In Portuguese.

Summary of Key Standards for Class I Medical Device Registration with ANVISA:

1. ANVISA Regulations:

   • RDC 185/2001: General guidelines for medical device classification and registration.
   • RDC 16/2013: Classification criteria for medical devices.
   • RDC 67/2009: Labeling requirements.

2. International Standards:

   • ISO 13485: Quality management system requirements.
   • ISO 14971: Risk management guidelines.
   • ISO 10993: Biocompatibility standards (if applicable).
   • IEC 60601: Electrical safety standards (if applicable).

3. e-PL System: Submissions must be made through ANVISA's electronic registration platform.

4. Portuguese Language: All documentation must be translated into Portuguese.

5. GMP Compliance: Evidence of adherence to Good Manufacturing Practices, especially for foreign manufacturers.

By ensuring that these standards and requirements are met, manufacturers can successfully apply for Class I medical device registration with ANVISA in Brazil.

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