The commercialization of medical devices (MD) in Brazil is regulated by ANVISA (National Health Surveillance Agency), which requires different levels of authorization depending on the type of product. Many companies and healthcare professionals often ask: what’s the difference between notification and registration? And how do risk classifications affect the regulatory process? Let’s explore these questions.
What are Notifications and Registrations with ANVISA?
Notification
Notification of medical devices is a simplified process aimed at low-risk products that pose minimal threat to user health. This is a faster regulatory path, requiring less documentation and a simpler regulatory review by ANVISA. However, this doesn’t mean notified products are exempt from safety and quality criteria.
Criteria for Notification: Notification applies mainly to Class I (low risk) products, and in some cases, Class II (low-medium risk) devices. For notification, devices must demonstrate that they are safe for their intended use and effective within acceptable safety and performance parameters. ANVISA requires basic data such as technical specifications, manufacturer identification, and compliance with national and international technical standards.
Required Documentation: When opting for notification, companies must submit a simplified dossier that includes:
- Certificates of conformity under the Brazilian Conformity Assessment System (SBAC), when applicable
- Labeling and usage instructions
- List of models
- Product image
- Description of similarities and differences in technical characteristics
Advantages: Notification is beneficial for lower-risk products, as the process is faster, with significantly shorter approval times compared to registration. Additionally, ANVISA’s review is less stringent, allowing notified products to enter the market more quickly.
Examples of Notified Products: Low-risk devices such as surgical gloves, syringes, digital thermometers, and bandages are usually subject to the notification process.
Registration
Registration, on the other hand, is mandatory for medium- to high-risk medical devices, requiring a deeper and more detailed review. Products that require registration must undergo a thorough evaluation of safety, efficacy, and technical compliance.
Criteria for Registration: Registration is required for Class III (medium-high risk) and Class IV (high risk) devices. These products have a more significant impact on patient health and life, demanding careful review of clinical evidence, manufacturing data, biocompatibility tests, performance studies, and clinical trials when applicable.
Required Documentation: The registration process is more rigorous and requires extensive technical documentation, including:
- Detailed description of the medical device
- Certificates of conformity under the Brazilian Conformity Assessment System (SBAC), when applicable
- Technical dossier following ANVISA’s current standards
- Good Manufacturing Practices (GMP) certification, ensuring the product is manufactured in compliance with applicable quality standards
- Labels, packaging, and instruction manuals validated by ANVISA
- Proof of compliance with legal provisions under specific medical device regulations
Approval Time and Evaluation: Registered products undergo a much more detailed review involving ANVISA’s specialized technical team, who evaluate safety, efficacy, and quality control. The approval time for registrations is significantly longer, often taking months depending on the complexity of the device and the dossier presented.
Examples of Registered Products: High-risk products such as pacemakers, defibrillators, orthopedic prostheses, dental implants, cardiovascular surgery devices, and life-support equipment (like ventilators) are required to go through the registration process.
Fundamental Differences Between Notification and Registration
| Criterion | Notification | Registration |
| Risk Level | Low (Class I) and low-medium (some Class II) | Medium (Class III) and High (Class IV) |
| Process Complexity | Simple, fast, and with less documentation | Complex, demanding, and with more documentation |
| Required Documentation | Basic, including a declaration of conformity and basic technical data | Complete, including clinical studies, biocompatibility reports, and manufacturing certificates |
| Approval Time | Short, due to the lower complexity of the process | Long, as it involves a detailed ANVISA analysis |
| Product Examples | Surgical gloves, syringes, bandages | Pacemakers, stents, orthopedic prostheses |
Medical Device Classification
ANVISA uses a risk classification system to determine the level of regulation required for each medical device. This system is based on the potential risk that the product may pose to the user.
- Class I – Low Risk: Products that pose minimal risk to the user and are usually exempt from registration, requiring only notification. Examples: disposable needles, simple wheelchairs.
- Class II – Low-Medium Risk: Devices with higher risk than Class I but still not significant. These products may also undergo notification but may have additional requirements. Examples: blood pressure monitors, surgical gloves.
- Class III – Medium-High Risk: These devices require a registration process, as they directly impact patient health and need proof of safety and efficacy. Examples: stents, hemodialysis equipment.
- Class IV – High Risk: These devices have the highest risk potential and require extremely rigorous analysis. They are generally used in critical procedures or life support. Examples: heart prostheses, pacemakers.
Types of Medical Devices
Medical devices can be classified into several categories depending on their function and application. Key types include:
- Medical Equipment
- In Vitro Diagnostic Products
- Implant Materials
- Surgical Instruments
- Hospital Use Products
- Software as a Medical Device (SaMD)
- Orthopedic Devices
The Importance of Regulatory Compliance
Maintaining compliance with ANVISA regulations is essential for companies to safely and legally market medical devices in Brazil. Non-compliance can result in severe penalties, such as fines, product recalls, and damage to the company’s reputation. Additionally, regulatory compliance ensures that products offered to the end consumer meet international quality and safety standards, strengthening the confidence of patients, doctors, and other healthcare professionals.
For companies, correctly following notification or registration processes ensures the swift and efficient introduction of new products into the market while avoiding future bureaucratic obstacles. Compliance is also a competitive advantage in the healthcare sector, where the quality and safety of devices are crucial aspects.
Conclusion
Understanding the differences between notification and registration, as well as the risk classifications of medical devices, is fundamental to ensuring regulatory compliance and successful market entry in Brazil. ANVISA plays an essential role in evaluating the safety and efficacy of products, protecting public health, and ensuring the quality of medical devices available in the country.
Staying updated on regulatory requirements and adapting processes to current standards is an indispensable task for manufacturers and distributors of medical devices. For a more detailed comparison between ANVISA, FDA, and MDR classifications, you can read the article “Comparative Classification of ANVISA, FDA, and MDR: Understanding the Key Differences.”
Learn More
If you have any questions about the notification and registration process for medical devices or need assistance in ensuring regulatory compliance, contact Brisa Advisors. We are ready to assist your company at every step of the process.
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