Overview
The National Health Surveillance Agency (ANVISA) has launched Collegiate Board Resolution (RDC) 936/2024, which establishes new guidelines for the regulation of health products. These changes aim to improve the safety and efficacy of products used in medicine, directly impacting health professionals and patients.
Introduction
Collegiate Board Resolution (RDC) No. 936/2024, published by the National Health Surveillance Agency (ANVISA), brought important updates to the guidelines that regulate health products in Brazil. This standard aims to guarantee greater safety, efficiency and quality in medical devices, as well as encouraging technological innovation in the sector.
The new resolution brings a renewed focus to the evaluation of health products, including medical devices and related products. One of the main changes is the requirement for greater transparency and rigor in the documentation submitted for the approval of new products, which could result in an increase in their quality and safety.
Healthcare professionals, such as doctors and nurses, will need to adapt to these new guidelines, ensuring that they are always using products that meet the new standards set by ANVISA. This is especially relevant in areas such as Aesthetic Medicine, where the use of quality healthcare products is crucial for patient safety.
Changes introduced by RDC 936/2024
RDC 936/2024 updates and modernizes fundamental aspects of the regulation of health products. The main points include:
Classification of Products by Risk Level:
The standard establishes new criteria for classifying medical devices into four risk categories (Classes I, II, III and IV). This ensures greater clarity in determining the regulatory requirements applicable to each product.
More Rigorous Clinical Trials:
Products classified as higher risk (Classes III and IV) must now undergo more robust clinical trials prior to marketing approval. The aim is to guarantee the safety and efficiency of medical devices before they reach patients.
Post-market monitoring:
Manufacturers and importers will have to implement detailed post-market surveillance plans, with mandatory periodic reports on the performance and possible adverse events of the products.
Fostering Innovation:
More streamlined regulatory procedures have been created for innovative technologies such as artificial intelligence-based devices, 3D printing and digital diagnostic tools.
Alignment with International Standards:
The resolution is in line with international standards, such as those adopted by the FDA (Food and Drug Administration) in the USA and the MDR (Medical Device Regulation) in the European Union. This facilitates the export of Brazilian products and expands market opportunities.
Impacts for Medicine and the Health Sector
The implementation of RDC 936/2024 will have significant implications for healthcare professionals, manufacturers and patients. Check out the main impacts:
1.0 Greater safety and confidence in devices
With the new requirements for clinical studies and monitoring, healthcare professionals and patients will have access to safer and more effective devices. This reduces risks associated with the use of medical technologies and contributes to improved clinical outcomes.
2.0 Accelerating the Adoption of New Technologies
Simplified processes for innovative products will allow advanced technological solutions to reach the market more quickly. This benefits areas such as telemedicine, diagnostic imaging and personalized treatments.
3.0 Adjustments for Manufacturers and Importers
Although the resolution brings benefits, it also poses challenges for companies in the sector. Adapting to the new rules may require investments in training, structuring processes and complying with stricter regulatory requirements.
4.0 Strengthening the Health System
Harmonization with international standards increases the credibility of Brazilian products, favouring the country’s integration into the global market and encouraging local research and development.
Challenges and opportunities
Despite the progress made, the implementation of RDC 936/2024 requires attention to a number of challenges:
Training Professionals: Adequate technical training will be essential for healthcare professionals to understand and use the new technologies correctly.
Cost of Compliance: Small and medium-sized manufacturers may face financial difficulties in meeting the stricter requirements.
Efficient Inspection: In order to guarantee compliance with the rules, ANVISA will need to step up its inspection and technical support activities.
Conclusion
RDC 936/2024 represents an important regulatory milestone for the healthcare products sector in Brazil. By establishing higher standards of safety and efficiency, the resolution also paves the way for the adoption of technological innovations that will transform the practice of medicine.
For healthcare professionals and companies in the sector, it’s time to adapt to the new guidelines and take advantage of the opportunities generated by this new regulatory scenario. The future promises greater safety, quality and technological advances in medicine, directly benefiting patients and strengthening the health system as a whole.
GRP Brazil
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References
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About Global Regulatory Partners
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.
GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and South Korea. GRP helps many life science companies register their products in different countries in compliance with local regulations.