Understanding Medical Device Classification in Brazil

Introduction

As Brazil continues to solidify its position as a significant player in the global medical device market, understanding its regulatory landscape becomes paramount for manufacturers aiming to enter or expand within this dynamic environment. A fundamental aspect of this landscape is the classification of medical devices, governed by the Brazilian Health Regulatory Agency (ANVISA). Proper classification not only ensures compliance but also influences the registration pathway, documentation requirements, and time to market.

ANVISA and the Regulatory Framework

ANVISA (Agência Nacional de Vigilância Sanitária) is the authoritative body responsible for the regulation and oversight of medical devices in Brazil. In September 2022, ANVISA introduced Resolution RDC No. 751/2022, which came into effect on March 1, 2023. This resolution replaced the long-standing RDC 185/2001 and consolidated various regulations, including those pertaining to risk classification, registration procedures, labeling, and instructions for use. Notably, RDC 751/2022 aligns Brazil’s classification rules more closely with the European Union’s Medical Device Regulation (EU MDR) 2017/745, incorporating 22 classification rules that consider factors such as invasiveness, duration of contact, and the device’s role in diagnosis or therapy.

Risk-Based Classification System

Under RDC 751/2022, medical devices are categorized into four classes based on their risk level:

• Class I: Low risk (e.g., surgical gloves, bandages)
• Class II: Medium risk (e.g., dental drills, diagnostic imaging equipment)
• Class III: High risk (e.g., orthopedic implants, ophthalmic lasers)
• Class IV: Very high risk (e.g., pacemakers, heart valves)

The classification determines the regulatory pathway:

• Notification: Applicable to Class I and II devices. This process is less stringent and does not require ANVISA’s pre-market review.
• Registration: Mandatory for Class III and IV devices. This involves a comprehensive review by ANVISA and is valid for ten years, subject to renewal.

 Key Classification Criteria

The classification of a medical device in Brazil is determined by several factors:

• Intended Use: The purpose for which the device is designed.
• Duration of Contact: How long the device is in contact with the body.
• Invasiveness: Whether the device penetrates the body, and if so, how deeply.
• Active vs. Non-Active: Whether the device relies on a source of energy other than that generated by the human body.
• Systemic vs. Local Effect: Whether the device’s effect is localized or systemic.

Manufacturers must carefully assess these criteria to determine the appropriate classification, as misclassification can lead to regulatory delays and increased costs.

Special Considerations

RDC 751/2022 introduces specific rules for emerging technologies:

• Software as a Medical Device (SaMD): Now explicitly addressed, with classification depending on the software’s intended use and risk.
• Nanomaterials: Devices incorporating nanomaterials are subject to particular scrutiny due to potential systemic exposure.

These additions reflect ANVISA’s commitment to keeping pace with technological advancements and ensuring patient safety.

Importance of Correct Classification

Accurate classification is crucial for several reasons:

• Regulatory Pathway: Determines whether the device undergoes Notification or Registration.
• Documentation Requirements: Higher-risk classes necessitate more comprehensive technical dossiers.
• Time to Market: Misclassification can result in delays due to re-evaluation and additional documentation.
• Compliance: Ensures adherence to Brazilian Good Manufacturing Practices (B-GMP) and other regulatory standards.

 How We Can Assist

As a seasoned medical device regulatory consultancy, we offer comprehensive support to manufacturers navigating Brazil’s regulatory landscape:

• Classification Assessment: We evaluate your device’s characteristics to determine the correct classification under RDC 751/2022.
• Regulatory Strategy: Develop a tailored plan to streamline the registration process, minimizing time and cost.
• Technical Dossier Preparation: Assist in compiling the necessary documentation in compliance with ANVISA’s requirements.
• Local Representation: Act as your Brazil Registration Holder (BRH), facilitating communication with ANVISA and ensuring ongoing compliance.

Conclusion

Understanding and correctly applying Brazil’s medical device classification system is a foundational step for market entry. With the implementation of RDC 751/2022, aligning with international standards, manufacturers have a clearer framework but must remain vigilant to ensure compliance. Partnering with experienced regulatory consultants can significantly ease this process, allowing you to focus on delivering innovative medical solutions to the Brazilian market.

References:

1. ANVISA. Resolution RDC No. 751/2022.
2. ANVISA. Medical Devices – Official Regulatory Page.
3. ANVISA. Resolution RDC No. 665/2022 – Good Manufacturing Practices.
4. ANVISA. Resolution RDC No. 687/2022 – GMP Certification Procedures.
5. ANVISA. Resolution RDC No. 830/2023 – Classification of IVD Devices.
6. ANVISA. Normative Instruction IN No. 290/2024 – Optimized Analysis Procedure.
7. ANVISA. Medical Device Single Audit Program (MDSAP).
8. ANVISA. MDSAP – Frequently Asked Questions.

For tailored regulatory support, contact Titans Medical Consulting—your partner in global medical device compliance.