To apply for Class I medical device registration with ANVISA (Brazilian Health Regulatory Agency), you must follow a set process and submit your application via ANVISA’s online platform, the e-PL system (Sistema Eletrônico de Peticionamento de Produtos para Saúde). Below is a step-by-step guide on how to apply for Class I medical device registration and where to apply.

Where to Apply:

• Platform: The registration application must be submitted through ANVISA’s e-PL system, which is the official electronic platform for submitting medical device registration applications.
  • Website: ANVISA e-PL Portal.
  • The e-PL system is the central point for submitting your application and all necessary documents to ANVISA, tracking the application status, and receiving the registration certificate once approved.

Step-by-Step Process to Apply for Class I Medical Device Registration:

1. Confirm Product Classification

• Before starting the application, confirm that your device is classified as Class I according to ANVISA’s RDC 185/2001 classification rule. Class I devices are low-risk medical devices and non-invasive, such as bandages, thermometers, etc.
  • Product Classification: Verify your device’s classification by consulting ANVISA guidelines or using classification tools if necessary.

2. Create an Account in the e-PL System

• Account Creation: You or your local representative (if you are a foreign manufacturer) must create an account in the e-PL system to submit the registration request.
  • Visit the official e-PL portal and follow the instructions to set up a user account.

3. Prepare Required Documents

You need to prepare and organize the required documents to support the Class I medical device registration. The following documents must be submitted:

• Product Description: Detailed description of the device, including its name, intended use, and technical characteristics.
• Risk Management Documentation: Simplified risk analysis (based on ISO 14971) to show how the risks of the device are managed.
• Safety and Performance Data: Results of any testing or data showing that the device performs as intended and is safe to use.
• Labeling and Instructions for Use: Product labeling and instructions, all in Portuguese, as per ANVISA’s requirements.
• Proof of GMP Compliance: For foreign manufacturers, proof of adherence to Good Manufacturing Practices (GMP), such as ISO 13485.
• Local Representative Documents: If you are an international manufacturer, provide a power of attorney designating a local Brazilian representative.

Ensure that all documents are clear, accurate, and translated into Portuguese.

4. Submit the Application via e-PL

• Login and Upload: Once you have an account and all required documentation, log in to the e-PL system and upload your files. Each document needs to be uploaded in the appropriate format (usually PDF).
  • Follow the prompts in the e-PL system to input the necessary details about the device and submit the documents for review.

5. Pay the Registration Fee

• There is a registration fee for processing Class I medical device applications. The fee generally ranges from BRL 1,500 to BRL 3,000, depending on the device and the current fee schedule from ANVISA.
  • The fee payment is typically processed through the e-PL system or a designated payment portal.

6. ANVISA Review and Approval

• ANVISA Review: After submitting the application, ANVISA will review the documentation. The review process for Class I devices typically takes 30 to 90 days.
  • If additional information or clarification is required, ANVISA may contact the applicant or the local representative.
  • ANVISA may request more documents if the initial submission is incomplete.

7. Receive the Registration Certificate

• If the application is approved, ANVISA will issue the registration certificate through the e-PL system.
  • The registration is valid for five years and must be renewed before expiry.

8. Post-Market Surveillance

• Compliance with Post-Market Obligations: After approval, the manufacturer and/or local representative are required to monitor the product’s performance in the market and report any adverse events or safety issues to ANVISA.
  • Additionally, you must ensure ongoing compliance with any changes to the device or regulations.

Summary of the Process:

1. Confirm the device’s classification as Class I.
2. Create an account in the e-PL system on ANVISA’s website.
3. Prepare required documents: Product description, labeling, risk analysis, GMP compliance, and local representative documents (if applicable).
4. Submit application through the e-PL system and pay the required registration fee.
5. ANVISA review of documents (typically 30–90 days).
6. Approval and receipt of the registration certificate.
7. Post-market surveillance obligations after registration.

Important Considerations:

• Language: All documents must be in Portuguese, including product descriptions, instructions for use, and labeling.
• Local Representation: If the manufacturer is located outside Brazil, a local representative is required to submit the registration on behalf of the manufacturer.
• Good Manufacturing Practices: For foreign manufacturers, proof of GMP compliance (ISO 13485) is essential.
• Application Fee: Be aware of the registration fee, which varies depending on the device and the specific cost structure at the time of application.

By following these steps and submitting the required documents through the e-PL system, you can apply for Class I medical device registration with ANVISA in Brazil.

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