New Brazilian Medical Device Regulation: What Should You Know (or Wish You Did) Before Entering the Brazilian Medical Device and Technology Market?
A review of the new medical device regulatory landscape in Brazil, with accompanying podcast, by Benny Spiewak of SPLaw – Spiewak e Carneiro Advogados.
The Brazilian Health Authority (ANVISA) has started enforcing a new Medical Devices Regulation (the “New Regulation”), revising the main framework governing the safety, marketing and classification of medical devices.
The New Regulation aims to align Brazilian rules with the medical device regulation of the Mercosur trade block (Resolution GMC 40/00) and to streamline local laws with international standards, reinforcing ANVISA’s emerging shift towards harmonisation and reliance routines. The New Regulation entered into force on 1 March 2023 and repealed the former Medical Device Regulation, which had been in effect for over two decades.
The procedures for notice, registration and maintenance of medical devices in the Brazilian market are summarised in the New Regulation – ie, Ruling 751/2022 of ANVISA’s Directorate – and outline precisely how the agency expects producers to reduce ambiguity and misinterpretation of rules. They also strengthen the Regulation‘s obligations towards emerging technologies, which were not previously specified.
Key Aspects of the New Regulation
In contrast to the EU’s Medical Device Regulation (which has multiple phase-in periods with which manufacturers must comply), the New Regulation has immediate effect. However, companies establishing their products are affected by the classification framework of the New Regulation – ie, from Class II to Class III – and have one year from the effective date to submit to the regulatory process necessary to change their product type. This is particularly relevant for software companies.
The New Regulation emphasises the concepts of product safety and quality, and introduces the following significant changes:
- reassessment and requalification of device risks based on technology advances;
- non-appealable rejection of faulty filings, including those aimed at securing marketing authorisation;
- phasing-out and market withdrawal rules for devices;
- updating the definition of medical devices by incorporating rules for Software as Medical Device (SaMD) solutions and nanotechnology-based materials; and
- streamlining labelling and use instructions for devices.
ANVISA has substantially considered Regulation (EU) 2017/745 as the benchmark for the New Regulation.
The New Regulatory Framework
From a SaMD perspective, ANVISA has updated the New Regulation based on a July 2022 SaMD-specific rule, designed to circumvent the existing regulatory gap for specific software applied as medical devices and to converge with international best practices, such as the regulatory models from the International Medical Device Regulators Forum (IMDRF).
In fact, by adopting the IMDRF-organised table of contents for the technical dossier, ANVISA has provided manufacturers with increased clarity and the ability to use documentation created for other jurisdictions for ANVISA pre-market approval.
The new regulatory framework applies to SaMDs:
- that adhere to the definition of medical devices;
- that are not embedded in specific medical device hardware; and
- whose applications are not exclusively for general well-being (eg, meditation apps).
Conversely, the definition includes Software as a Service (SaaS) that fulfills the purpose of a medical device. In contrast, accessory software whose application is exclusive to a specific medical device must be jointly authorised with that medical device.
Processes and Outlook
Compared with recent medical device regulation updates by other relevant regulatory authorities, the New Regulation has yet to show whether it per se complicates the currently existing governing structure – ie, there are no additional rules or requirements for risk management, quality management and post-market surveillance systems. The New Regulation demonstrates a facilitation component by consolidating almost two dozen ancillary rules issued by ANVISA during the lifespan of the former regulation.
More importantly, the New Regulation sends a loud and clear message. Complete regulatory harmonisation is not on ANVISA’s horizon. International medical device companies and interests must realise that Brazil has individual regulatory dynamics, realities and requirements, as evidenced by the New Regulation.
“Most failures have come from submissions that heavily relied on other markets.”
Based on the above-discussed, understanding of the New Regulation is essential before placing a medical device on the Brazilian market. The following must also be borne in mind.
- The New Regulation now requires SaMD licensors or rights-holders to ensure the relevant solution has been certified by ANVISA. A marketing authorisation holder must ensure that ANVISA has fully approved the company.
- Foreign entities without a Brazilian ANVISA-certified subsidiary or distributor may not secure a Brazilian marketing authorisation for a medical device, whose definition now includes SaMD.
- To legally sell medical devices in Brazil, foreign manufacturers must appoint a Brazilian registration holder to act as the company’s authorised local representative and submit the required Brazilian Portuguese-written data and documentation to ANVISA.
- Class I and Class II medical devices and IVDs must adhere to a streamlined notification system. Although ANVISA will not conduct a technical review of the applications, it still requires such. Class III and Class IV medical devices require certification with ANVISA through the so-called registro, which commences when producers evidence that Brazilian Good Manufacturing Practices (BGMP) criteria are met.
- Regulation RDC 665/2022 establishes Brazil’s Quality Management Systems standards for Medical Devices. Medical devices and in vitro diagnostics can only be sold in Brazil if they comply with BGMP. Along with the US, Canada, Australia and Japan, Brazil is a Medical Device Single Audit Program member.
- Usually, ANVISA authorises Class I and Class II devices up to 30 days from filing. For Class III and Class IV, such timelines vary from nine to 20 months from filing.
The New Regulation stresses the standalone approach manufacturers or medical device distributors must take when considering the Brazilian market. Most failures have come from submissions that heavily relied on other markets. In contrast, successes have resulted from those works that managed to address the specific features and requirements of Brazil and ANVISA.
SPLaw – Spiewak e Carneiro Advogados
