When registering a Class III medical device with Brazil's ANVISA, comprehensive technical documentation is required to demonstrate the safety, efficacy, and quality of the device. The technical documents must comply with ANVISA's regulatory standards and provide sufficient evidence that the device meets all necessary requirements for approval. Below is a detailed list of the technical document requirements for Class III medical device registration:

1. Device Description

• Detailed description of the medical device, including its:
  • Intended use and indications for use.
  • Principle of operation and any technological characteristics.
  • Design and materials used in manufacturing.
  • Intended patient population (e.g., adults, children).
• This should also include any device components and accessories that are marketed with the device.

2. Clinical Data

• Clinical evidence is critical for Class III devices, which are considered high-risk. You must provide data demonstrating that the device is safe and effective.
• Clinical Studies: If applicable, submit the results of clinical trials or studies that support the device’s safety and effectiveness. These trials should adhere to Good Clinical Practice (GCP) and ISO 14155 standards.
• Post-market Clinical Data: If the device has already been marketed in other countries, provide post-market surveillance data, including adverse event reports or safety data, to further demonstrate its safety and performance.
• Risk/Benefit Analysis: A detailed risk management plan (typically according to ISO 14971) to evaluate and mitigate risks associated with the device.
• Data on any previous regulatory approvals (e.g., FDA, CE mark) if the device has been approved elsewhere.

3. Risk Management Documentation

• A Risk Management Plan must be submitted to show that the device meets the requirements of ISO 14971 (the international standard for risk management in medical devices).
• The document should include:
  • Identification of potential risks associated with the device.
  • Risk evaluation and mitigation measures to ensure the device is safe for use.
  • Residual risks that remain after implementing control measures, if applicable.

4. Labeling and Instructions for Use

• Product labeling must be provided in Portuguese and should include the following:
  • Device name and model.
  • Manufacturer’s name and address.
  • Indications for use, contraindications, and precautions.
  • Batch number, serial number, and expiration date (if applicable).
  • Storage conditions and any specific handling instructions.
• Instructions for Use (IFU): Detailed instructions on how to use the device safely and effectively. This document must include:
  • Step-by-step use instructions.
  • Warnings, precautions, and potential adverse effects.
  • Maintenance and cleaning guidelines (if applicable).
• Symbols: Any symbols used on the labeling must comply with international standards (e.g., ISO 15223-1 for symbols used in medical device labeling).

5. Manufacturing and Quality Control Documents

• Good Manufacturing Practices (GMP) compliance documentation is required. For foreign manufacturers, ANVISA may request proof of GMP certification from a recognized body such as ISO 13485.
• The Quality Management System (QMS) must comply with ISO 13485 or equivalent standards, ensuring that the device is produced under controlled conditions to meet safety and quality standards.
• Documentation of quality control procedures and inspection processes for the device’s manufacturing.

6. Technical Specifications and Standards Compliance

• Device Specifications: Detailed information on the device's technical specifications, including performance characteristics, materials, and manufacturing processes.
• Compliance with relevant international standards: Provide evidence that the device complies with standards such as ISO 10993 (biocompatibility), IEC 60601 (electrical safety for medical devices), and other applicable standards for the specific type of device (e.g., ISO 13485, ISO 14971, ISO 14155).
• If the device includes electrical components or software, the manufacturer must provide evidence that the device complies with IEC 60601 (for electrical safety) and IEC 62304 (for software life cycle processes).

7. Pre-clinical Test Data (if applicable)

• If relevant to the device, provide pre-clinical test data demonstrating the safety and performance of the device in laboratory or simulated environments.
• Examples of tests could include:
  • Biocompatibility tests (following ISO 10993).
  • Sterility and microbiological tests (for sterile devices).
  • Mechanical testing, if applicable (e.g., for orthopedic devices).

8. Statement of Conformity

• A Statement of Conformity to relevant international standards (such as ISO 13485, ISO 14971, ISO 10993, IEC 60601, etc.) must be submitted, confirming that the device complies with the applicable regulatory requirements.
• This statement often comes with supporting certificates or declarations from third-party auditors.

9. INMETRO Certification (if applicable)

• If the device includes electrical or electronic components, INMETRO certification may be required. This certification ensures that the device complies with Brazilian National Institute of Metrology, Quality, and Technology standards, especially for electrical safety.
• Submit the relevant INMETRO certification if required for the device.

10. Post-Market Surveillance and Vigilance Plan

• Post-market surveillance data is required for Class III devices to demonstrate ongoing safety and performance after the device is introduced to the market.
• A vigilance plan outlining procedures for reporting adverse events, complaints, and device recalls must be submitted.

11. Other Specific Requirements (if applicable)

• Depending on the type of Class III medical device (e.g., implantable, diagnostic, active medical device), additional documentation or specific regulatory requirements may apply.
• For example, if the device uses software, a Software Life Cycle document (per IEC 62304) may be required.

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