Brazil is the largest medical device market in Latin America, offering immense opportunities for manufacturers. However, its regulatory system is complex and governed by the Agência Nacional de Vigilância Sanitária (ANVISA). ANVISA oversees the registration of medical devices, the maintenance of registered products, and the Brazilian Good Manufacturing Practices (B-GMP) audit process.

The key regulation, RDC 751/2022, has been in effect since March 1, 2023, and serves as Brazil's cornerstone for medical device compliance. This regulation outlines the registration protocol and specifies the documentation required to register legally and market medical devices in the country.

Understanding and navigating ANVISA's requirements for manufacturers aiming to enter the Brazilian healthcare market. With offices in Brasília and São Paulo, Qserve's team provides local expertise to guide you through ANVISA's regulations. From interpreting complex requirements to ensuring full compliance, we help you efficiently bring your devices to market.

Leverage Qserve's in-depth global network to meet RDC 751/2022 requirements, align with MDSAP and IMDRF standards, and successfully access the Brazilian market.

In Brazil, medical devices are classified based on risk into four categories:

Class I (low risk)
Class II (medium risk)
Class III (high risk)
Class IV (maximum risk)

Manufacturers must follow the 22 classification rules outlined in Annex I of RDC 751/2022 to ensure proper classification. These rules were recently updated to align with the IMDRF classification system, incorporating specific guidelines for:

1. Software as a Medical Device (SaMD) under Rule 11.
2. Nanomaterials under Rule 19.

If there is any uncertainty regarding classification after applying these rules, ANVISA will determine the appropriate category.

Submission Processes Based on Risk Classification
Class I/II Devices: Submitted to ANVISA through Notification (“Notificação”).

Class III/IV Devices: Submitted using the more detailed Registration process (“Registro”).

Classification for IVDs
The classification rules for in vitro diagnostics (IVDs) differ significantly from those for medical devices. This approach is consistent with the regulatory frameworks in other LATAM countries.

Understanding these distinctions and processes is crucial for compliance with Brazil's regulatory requirements.

Contact Qserve to learn more about navigating Brazil's medical device regulations and ensuring proper classification and submission for your products. Our team of experts can guide you through the complexities of ANVISA’s processes to achieve market access efficiently.

All manufacturers seeking to register medical devices in Brazil must comply with Brazilian Good Manufacturing Practice (B-GMP) requirements, regardless of the device’s risk classification. B-GMP focuses on the quality control processes for manufacturing devices, complementing the technical requirements of the devices themselves.

B-GMP Compliance for Class I and II Devices
For Class I and II devices submitted through the Notification route (Notificação), manufacturers must:

Declare their knowledge of and adherence to B-GMP standards.
Ensure their processes align with B-GMP guidelines as part of the submission process.

B-GMP Certification for Class III and IV Devices
The process begins with a formal protocol requesting B-GMP certification for Class III and IV devices submitted through the Registration route (Registro). The device registration is contingent upon the issuance of the B-GMP certificate, which requires:

ANVISA conducted an on-site audit of every factory unit involved in production.
Verify compliance with Brazilian quality standards before market approval.
B-GMP certificates are valid for two years, and after this period, ANVISA may grant recertification based on documentation analysis rather than requiring another on-site inspection for overseas manufacturers. While an MDSAP certificate serves as a helpful reference and can accelerate the B-GMP approval process, it does not replace the requirement for B-GMP certification.

B-GMP certification is essential for demonstrating the quality and reliability of medical devices in the Brazilian healthcare market. Compliance ensures manufacturers meet Brazil's stringent standards, gaining the trust of regulators and healthcare providers.

Qserve’s regulatory experts guide you through the B-GMP compliance process, from preparation to successful certification, ensuring a smooth pathway to market entry in Brazil.