When applying for Class I medical device registration with ANVISA in Brazil, certain technical documents must be submitted to demonstrate the safety, performance, and compliance of the device with Brazilian regulations. Class I devices are considered low-risk and non-invasive, so the technical documentation required is typically less extensive than for higher-risk classes, but it still ensures that the device is safe and effective for its intended use.

Technical Document Requirements for Class I Medical Device Registration with ANVISA:

1. Product Description

   • A detailed description of the device, including:
     • The name of the device.
     • Intended use: Clear explanation of the device’s intended purpose and functionality.
     • Design and Composition: Information on the materials used, dimensions, and how the device works.
     • Any accessories or parts that are included with the device, if applicable.

2. Risk Management Documentation

   • Risk analysis: A simplified risk management document to identify and address any potential risks associated with the device. This is based on international standards such as ISO 14971, which provides guidelines for risk management in medical devices.
   • The risk analysis should include:
     • Identification of potential hazards.
     • An assessment of the risks associated with the device’s use.
     • How risks are mitigated to ensure the device’s safety.

3. Device Performance and Safety Data

   • Evidence of performance and safety: For Class I devices, you must provide data demonstrating that the device functions as intended and is safe to use. This might include:
     • Test reports (if applicable), such as performance testing or material safety testing.
     • Evidence that the device complies with relevant international standards (e.g., ISO 13485, ISO 10993 for biocompatibility, etc.).

4. Labeling and Instructions for Use (IFU)

   • Product labeling: Labels on the device and its packaging must comply with Brazilian requirements, including:
     • The name and address of the manufacturer or local representative.
     • The intended use and any warnings or precautions.
     • Lot or batch numbers (for traceability).
     • Expiration date (if applicable).
     • Portuguese language: Labels must be in Portuguese.
   • Instructions for Use (IFU): Clear, concise instructions on how to use the device safely, including:
     • Usage guidelines.
     • Storage, cleaning, and maintenance instructions (if applicable).
     • Warnings and contraindications.

5. Good Manufacturing Practices (GMP) Compliance

   • For foreign manufacturers, you must provide evidence of compliance with Good Manufacturing Practices (GMP). This is typically demonstrated by ISO 13485 certification or equivalent quality management system certification.
   • GMP certification verifies that the manufacturer follows appropriate procedures for design, production, testing, and quality control to ensure the safety and effectiveness of the device.

6. Quality Management System (QMS) Documentation (If Applicable)

   • If applicable, provide documentation demonstrating that the manufacturer adheres to an established Quality Management System (e.g., ISO 13485) to ensure continuous quality control throughout the product lifecycle.

7. Biocompatibility Testing (If Applicable)

   • If the device is intended to come into contact with the human body, you may need to submit biocompatibility testing data to show that the materials used in the device are safe and do not pose a risk of adverse reactions. This is typically based on ISO 10993 standards for the biological evaluation of medical devices.

8. Local Representative Documentation (For Foreign Manufacturers)

   • If you are a foreign manufacturer, you must provide a power of attorney designating a local representative in Brazil. The local representative is responsible for communication with ANVISA and handling regulatory matters.
   • The power of attorney must clearly state that the representative has the authority to act on behalf of the manufacturer in Brazil.

Additional Documents for Specific Cases:

• Clinical Data: Although Class I devices typically do not require clinical data, if your device has specific claims related to health benefits, a risk of clinical impact, or a special intended use, ANVISA may request clinical performance data or studies.
• Certificate of Free Sale (CFS): If the device is sold in other countries, ANVISA may ask for a Certificate of Free Sale, which verifies that the device is legally marketed in the manufacturer's country of origin.

Submission Format and Language:

• All documents must be submitted in Portuguese. If you are a foreign manufacturer, ensure that all documents are translated into Portuguese by a certified translator.
• You will upload the documents electronically through ANVISA’s e-PL system, which is the official platform for submitting medical device registration applications.

Summary of Key Technical Document Requirements:

1. Product description (device name, intended use, materials, design).
2. Risk management documentation (risk analysis based on ISO 14971).
3. Performance and safety data (test reports, compliance with international standards).
4. Labeling and Instructions for Use (IFU) (in Portuguese, including warnings and precautions).
5. Good Manufacturing Practices (GMP) compliance (ISO 13485 or equivalent, if applicable).
6. Quality Management System documentation (if applicable).
7. Biocompatibility testing (for devices in contact with the body, if applicable).
8. Local representative documentation (if the manufacturer is foreign).
9. Other documents (clinical data, certificate of free sale, etc., if applicable).

By ensuring that these technical documents are prepared and submitted accurately, you will be able to apply for Class I medical device registration with ANVISA.

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