Brazil aligns medical device regulations with global standards, including Europe and the US. Recent updates and international compatibility attract manufacturers.
In recent years, regulatory bodies for medical devices in Brazil, Mexico, and other Latin American countries have increasingly aligned their requirements with major global markets like Europe and the United States. By following guidelines from the International Medical Device Regulators Forum (IMDRF), these nations aim to harmonize registration and approval processes for medical devices. This global alignment simplifies the pathway for manufacturers to navigate various markets more seamlessly.
Brazil has seen significant regulatory updates between 2022 and 2024, reflecting its commitment to maintaining high standards and ensuring compatibility with international norms. These updates are critical for manufacturers aiming to enter or expand within the Brazilian market:
1. RDC 751/2022
- This regulation replaced RDC 185/2001 after 21 years.
- Key updates include:
- Aligning the definition of “Medical Device” with the European Medical Devices Regulation (MDR).
- Incorporating the 22 rules from MDR Annex VIII.
- Adopting the IMDRF guidance for market authorization technical dossiers.
- Changing the registration moniker for the lowest-risk medical devices from “Cadastro” to “Notificação.”
2. RDC 830/2023
- Effective from June 1, 2024, this regulation harmonizes the requirements for In Vitro Diagnostic (IVD) Medical Device Market Authorization within Mercosur.
- It includes updates to submission documentation, electronic Instructions for Use, and classification rules.
3. RDC 837/2023
- This update simplifies the clinical investigation submission process and adopts convergent terminology related to medical device development.
4. RDC 848/2024
- This regulation updates essential safety and performance requirements and revokes RDC 546/2021, extending its scope to include IVDs.
5. RDC 902/2024
- Provides for the inclusion of a statement about a new formula in the labeling of products subject to health surveillance when their composition is changed.
6. RDC 903/2024
- Provides for the procedures for the transfer of ownership of registration of products subject to health surveillance, global transfer of responsibility for clinical trials and updating of registration data related to the operation and certification of companies, as a result of corporate transactions or commercial operations.
7. Reliance Mechanisms for Market Authorizations
- Brazil will now accept certificates from equivalent foreign regulatory authorities for expedited market authorization reviews.
- Initially, this applies to authorities from the founding members of the Medical Device Single Audit Program (MDSAP).
8. Use of MDSAP by ANVISA
- MDSAP audit reports are accepted for issuing and renewing Good Manufacturing Practice (GMP) certificates by ANVISA, with a pilot program starting in late 2023.
Brazil's medical device market is expanding, driven by several key factors:
- Sistema Único de Saúde (SUS): Serving millions, including vulnerable populations, SUS drives demand for medical devices, stimulating large-scale procurement and production.
- Elderly Population: The growing number of individuals over 65 years old increases the need for medical equipment.
The regulatory updates and alignment with international standards are making Brazil an attractive destination for medical device manufacturers. The dynamic regulatory landscape ensures safety, quality, and compliance, essential for companies entering the Brazilian market.
Navigating Brazil's regulatory environment is essential for the success of medical device companies looking to enter the market. Brazil medical device registration is managed by ANVISA, the country's regulatory authority, which plays a critical role in upholding these stringent standards. At Pure Global, our experienced professionals specialize in regulatory affairs in Brazil, providing expert guidance throughout the Brazil medical device registration process for both medical devices and in-vitro diagnostic products. With our deep expertise and local knowledge, we ensure a smooth market entry while ensuring full compliance with Brazil's evolving regulations.
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