Introduction
The regularization of medical devices with ANVISA is a complex process that requires in-depth technical knowledge and attention to regulatory details. With the implementation of RDC 751/2022 and other current regulations, it is essential that companies in the medical device sector adopt efficient practices to avoid rejections and procedural delays.
This guide presents 9 essential practices based on our experience and knowledge of the main Brazilian regulatory requirements.
1. Ensure Complete Document Delivery
Recommended Practices:
- Ensure all mandatory documents required by legislation are submitted, including complete, signed, and legible forms
- Verify that all documents comply with standards established by RDC 751/2022
- Include GMP certifications when applicable
- For devices with SAMD (Software as Medical Device), ensure all specific technical documentation is included
Avoid:
- Leaving blank fields or providing incomplete information
- Illegible documents or documents with erasures
2. Keep Documents Updated
Recommended Practices:
- Verify that certificates (e.g., GMP, ISO 13485, INMETRO, Free Sale Certificate) are valid and within deadline
- Keep all quality and conformity certificates updated
- For imported products, ensure consular documentation is apostilled or consularized
Special Attention:
- Imported products: Send the consularized or apostilled authorization letter in Portuguese, English, or Spanish with sworn translation (when applicable)
3. Present Clinical Evidence for Technological Innovation
Recommended Practices:
- If the product has innovative technology or indication, include clinical evidence proving its efficacy and safety
- Present clinical studies according to international guidelines
- Properly document laboratory developed tests when applicable
Importance: Clinical evidence is fundamental for products with indications or technologies not established in the Brazilian market.
4. Classify the Product Correctly
Recommended Practices:
- Ensure you use the appropriate risk classification, petition code, and correct technical name in the application
- An error here can generate immediate rejection
- Consult legislation to confirm details before submission
5. Pay the GRU Correctly and On Time
Recommended Practices:
- Don’t forget to pay the ANVISA GRU with the correct amount and within the established deadline
Attention: Incorrect payment can delay the entire process and generate financial loss.
6. Be Prepared for Additional Requirements
Recommended Practices:
- When requested, provide additional information that proves additional quality or product efficacy
- Anticipate by aligning all internal processes of your company
- Always have supporting technical documentation available
Avoid:
- Last-minute submissions: Send documents within the deadline indicated by ANVISA. Delays can lead to process rejection
7. Labeling and IFU According to Current Legislation
Recommended Practices:
- Ensure labeling and Instructions for Use (IFU) are complete, clear, and adequate to current legislation
- Include UDI (Unique Device Identification) information when applicable
Practical Tip: Check current resolutions to ensure no information is missing in IFUs.
8. Pay Attention to Quality and Presentation of Submission
Recommended Practices:
- Use legible documents that are not obsolete. This will facilitate analysis and avoid rework
- Organize documentation clearly and sequentially
- Documents are accepted in Portuguese, Spanish, and English
Benefits: Professional presentation accelerates the analysis process and demonstrates company seriousness.
9. Rely on Specialists to Avoid Errors and Reduce Risks
Recommended Practices:
- Work with experienced professionals in regulatory affairs who have deep knowledge of the process and offer integrated and customized solutions for your needs
- Maximize chances for approval without delays!
Conclusion
Safe submission of processes to ANVISA requires adequate preparation, specialized technical knowledge, and attention to regulatory details. Following these 9 essential practices significantly increases approval chances in the first analysis cycle, avoiding additional costs and delays in product launches.
For companies seeking regulatory excellence, investment in specialized medical device consulting is fundamental to safely navigate the complex Brazilian regulatory environment and maximize growth opportunities in the medical device market.
Find out more about BPO in RA!
*Budget for registration ownership transfer, Market Access Strategy, and BPO in RA services for your company: www.brisa.com.br
