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Changing Global Markets - Brazil: Navigating New Regulatory Landscapes

Brazil aligns medical device regulations with global standards, including Europe and the US. Recent updates and international compatibility attract manufacturers.

Written by:
Angelica Rodrigues da Silva
Published on:
June 18, 2024

Regulatory Alignment in Latin American Markets

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.

Recent Regulatory Updates in Brazil (2022-2024)

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. 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).

6. 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.

Growing Medical Device Market in Brazil

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 crucial for the success of medical device companies. ANVISA, the regulatory authority, plays a pivotal role in maintaining these standards. At Pure Global, our professionals possess extensive experience in regulatory affairs in Brazil, offering expert guidance through the registration process for medical devices and in-vitro diagnostic products. With our expertise and local knowledge, we facilitate smooth market entry and compliance with Brazil's evolving regulations.

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