Once Class I medical device registration with ANVISA in Brazil is approved, there are several steps and obligations that manufacturers and importers must follow to ensure ongoing compliance and to bring the device to market. Here’s what to do after obtaining ANVISA approval:

1. Obtain the Registration Certificate

• After ANVISA approval, the manufacturer or authorized representative (if foreign) will receive the official Registration Certificate for the device.
• This certificate is typically issued electronically through the e-PL system and confirms that the device is legally approved for sale in Brazil.

2. Comply with Post-Market Surveillance Requirements

• ANVISA requires manufacturers to implement post-market surveillance (PMS) systems to monitor the safety and performance of medical devices after they are marketed.
• This may include:
  • Incident reporting: If there are any adverse events or malfunctions related to the device, they must be reported to ANVISA.
  • Post-market clinical follow-up: For some devices, particularly if new or innovative, ongoing clinical data may be required.
• Make sure to report any recalls, adverse events, or device failures to ANVISA as per regulatory guidelines.

3. Labeling and Packaging Compliance

• Ensure that all product labeling and packaging comply with Brazilian regulations as outlined by RDC 67/2009.
• The labeling should include:
  • Manufacturer’s name and address.
  • Intended use.
  • Batch or lot numbers.
  • Expiry date (if applicable).
  • In Portuguese: All labeling information must be provided in the Portuguese language.

4. Commercialization of the Product

• After obtaining the registration certificate, the device can be sold in Brazil. Manufacturers and distributors must:
  • Ensure distribution channels are compliant with ANVISA regulations.
  • Maintain proper documentation for inspection or audits by Brazilian authorities if needed.
  • Implement quality control to ensure the device’s continued safety and effectiveness throughout its lifecycle.

5. Maintain Good Manufacturing Practices (GMP)

• For foreign manufacturers, the GMP certification may need to be maintained and updated regularly.
• Local representatives (if applicable) are responsible for ensuring that the foreign manufacturer maintains compliance with the Brazilian GMP requirements.
• ANVISA may perform audits to ensure that the manufacturing facility complies with GMP standards.

6. Keep the Registration Updated

• Product updates: If any changes occur in the device’s design, labeling, or manufacturing process, they must be communicated to ANVISA for review and approval. This may involve submitting an amendment to the registration.
• If the device is discontinued or withdrawn from the market, ANVISA should be notified.
• Annual Renewal: While Class I devices typically do not require regular renewal of registration, it’s important to stay updated on any new regulations or changes in ANVISA requirements.

7. Import and Distribution Process

• Importation: If the device is being imported into Brazil, the registered device must go through the Brazilian Customs (Receita Federal), and the importer will need to provide proof of ANVISA registration at customs.
• The importer must also adhere to ANVISA’s requirements for imports, including keeping records and maintaining updated documentation regarding the device.

8. Maintain Traceability and Recordkeeping

• Manufacturers, importers, and distributors should keep comprehensive records of:
  • The batch numbers, production dates, and distribution channels of the medical device.
  • Any adverse events, complaints, or customer feedback related to the device.
  • Detailed records of all post-market activities, including any clinical studies or follow-up actions.

9. Surveillance and Inspections

• ANVISA can conduct inspections of manufacturing facilities or storage/distribution points in Brazil. It's important to maintain compliance with Brazilian health regulations in case of such inspections.
• Manufacturers should be prepared for periodic audits and maintain the quality control systems required to meet ANVISA's standards.

10. Stay Updated on Regulatory Changes

• Regulatory requirements in Brazil may change over time. It is crucial for manufacturers and importers to stay informed about:
  • Changes to ANVISA regulations.
  • Updates to international standards.
  • New guidelines or enforcement practices related to medical devices.
• Monitoring ANVISA’s official communications and subscribing to relevant updates can help you stay compliant with any new requirements.

Summary of Post-Approval Steps:

1. Obtain the Registration Certificate through ANVISA’s e-PL system.
2. Implement Post-Market Surveillance to monitor the device’s safety and report any issues to ANVISA.
3. Ensure Labeling and Packaging Compliance with Brazilian regulations.
4. Commence Commercialization in Brazil, ensuring regulatory compliance.
5. Maintain GMP Compliance, especially for foreign manufacturers.
6. Keep the Registration Updated with any changes or discontinuation of the device.
7. Ensure Importation Compliance for products entering Brazil.
8. Maintain Traceability of the product’s lifecycle and related documentation.
9. Prepare for Inspections and audits from ANVISA.
10. Stay Updated on Regulatory Changes to ensure ongoing compliance.

By following these steps, manufacturers can ensure their Class I medical device remains compliant and successfully marketed in Brazil.

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