Regulation of High-Risk and Maximum-Risk Medical Devices in Brazil: Advances and Challenges

Introduction

The regulation of medical devices in Brazil, carried out by ANVISA, plays a crucial role in ensuring public health protection. This is achieved by making sure that only products that meet stringent safety and efficacy standards are allowed to reach the market. Given the potential risks associated with medical devices, this regulatory framework is essential in maintaining high standards of patient care and safety. 

ANVISA’s Approval Process: What MedTech Companies Need to Know

The process of regulating high-risk and maximum-risk medical devices in Brazil involves a comprehensive set of steps and requirements that companies must fulfil to introduce their products into the Brazilian market. It all begins with the submission of a detailed dossier to ANVISA. This dossier must contain extensive information about the medical device, including its design, materials used, manufacturing methods, and clinical data that demonstrate its efficacy and safety. The dossier also includes technical documentation that supports the claims made about the device’s performance and risk management strategies. 

In addition to the technical analysis of the submitted dossier, ANVISA conducts a thorough assessment of the company’s manufacturing processes and quality control systems. Manufacturers are required to demonstrate adherence to Good Manufacturing Practices (GMP). This ensures that their production processes consistently devices that meet predefined quality standards. Moreover, companies must have robust control systems in place to monitor and ensure the safety and effectiveness of their products throughout their lifecycle, from production to post-market surveillance. Furthermore, companies that hold the Medical Device Single Audit Program (MDSAP) certification benefit from an extended validity of their GMP certificate issued by ANVISA, increasing from 2 years to 4 years, providing cost reduction and agility on the certification process. 

Given the increasing globalisation of the medical device industry and the growing complexity of these products, ANVISA recognised the need to streamline the approval process for high-risk and maximum-risk devices. To address this need, ANVISA introduced Normative Instruction IN 290/2024, which aims to optimise the approval process for medical devices that have already been evaluated by international regulatory authorities recognized as equivalent to ANVISA in terms of rigor and quality. 

Normative Instruction IN 290/2024 establishes an optimised procedure specifically for the analysis and decision-making process regarding the registration applications of high-risk and maximum-risk medical devices. The process relies on evaluations conducted by foreign regulatory authorities that ANVISA has recognised as equivalent. The aim of this normative instruction is to simplify the regulatory process, reduce redundant evaluations, and accelerate the introduction of new devices into the Brazilian market. This not only benefits manufacturers by reducing time to market but also patients, who gain faster access to innovative medical technologies. 

The IN 290/2024 recognizes four key foreign regulatory authorities as equivalent, based on the stringent quality and thoroughness of their regulatory evaluations. These authorities include: 

1. Australia (TGA) 
2. Canada (Health Canada)
3. United States (FDA) 
4. Japan (PMDA)  

Aspects of IN 290/2024

Optimised Evaluation Procedure: Under IN 290/2024, medical devices that have been evaluated and approved by one of the recognised regulatory authorities can be registered in Brazil through an optimised process. This process allows ANVISA to accept evaluations conducted by these foreign authorities as part of the registration process in Brazil. This means that the rigorous assessments already performed by these authorities are considered sufficient to meet Brazilian regulatory standards, thereby reducing duplication of effort and speeding up the time to market. 

Documentation Requirements: For ANVISA to accept the external evaluation, companies must provide complete and detailed documentation. This includes evaluation reports from the recognised foreign authorities, evidence of compliance with international standards, and any additional information requested by ANVISA. The documentation must clearly demonstrate that the device meets safety and performance standards equivalent to those required in Brazil. Furthermore, the medical device must be essentially identical in terms of technical specifications and intended use to the one being registered in Brazil. This ensures that the product’s performance and safety have been thoroughly vetted and are consistent with international standards. 

Compliance Assurance: Although IN 290/2024 streamlines the approval process, ANVISA retains final responsibility for the approval of medical devices in Brazil. The agency conducts its own thorough review to ensure that all specific Brazilian requirements are met. This dual-layered approach guarantees that products not only meet international standards but also comply with local regulations, which may have unique requirements reflecting the specific needs of the Brazilian healthcare system. 

Review and Decision Procedure: IN 290/2024 defines a clear and efficient procedure for the review of registration applications. This includes the analysis of the submitted documentation, verification of compliance with ANVISA’s specific requirements, and decision-making based on the evaluations provided by the recognised foreign authorities. This optimised procedure is designed to reduce the time required for review and to expedite the introduction of new medical devices into the Brazilian market. By streamlining these steps, the process becomes more predictable and transparent, benefiting all stakeholders involved. 

Impacts of IN 290/2024

Reduction in Approval Time: One of the most significant benefits of IN 290/2024 is the substantial reduction in the time required for the approval of medical devices. By accepting evaluations already conducted by recognised foreign regulatory authorities, ANVISA can process applications more efficiently. This efficiency allows for quicker market entry of new devices, which is crucial for patients who may benefit from innovative treatments and technologies. 

Improved Access to Innovations: The optimisation of the approval process under IN 290/2024 also facilitates faster access to innovations and advanced technologies in the Brazilian market. Devices that have been approved by leading regulatory authorities, such as the FDA and TGA, can be introduced into Brazil more swiftly. This not only enhances the competitiveness of the Brazilian market but also ensures that patients have timely access to the latest medical advancements, which can improve healthcare outcomes and quality of life. 

Increased Confidence in the Regulatory System: The acceptance of evaluations from internationally recognised regulatory authorities under IN 290/2024 reinforces confidence in the Brazilian regulatory system. By aligning its processes with international best practices, Brazil demonstrates that its regulatory framework is robust and reliable. This alignment with global standards can strengthen the perception of the Brazilian market’s reliability on the international stage, potentially attracting more foreign investment and partnerships in the medical device sector. 

Endnote

IN 290/2024 represents a significant advancement in the regulation of medical devices in Brazil. It offers a more agile and efficient process for the analysis and decision-making of registration applications based on evaluations from equivalent foreign regulatory authorities. By recognising the quality of evaluations conducted by entities such as TGA, Health Canada, FDA, and PMDA, ANVISA is facilitating the entry of new devices into the Brazilian market and promoting a more competitive and innovative environment.  

While the implementation of IN 290/2024 presents challenges, such as the need for continuous international coordination and monitoring, the benefits it offers – reduced approval times, and improved access to innovations – are significant. The regulation strengthens confidence in the Brazilian regulatory system and contributes to the continuous improvement of the healthcare system. Ultimately, it ensures that patients in Brazil have access to safe, effective, and innovative medical devices more quickly and efficiently, enhancing the overall quality of care available in the country. 

Disclaimer. The views and opinions expressed in this article are solely those of the author and do not necessarily reflect the official policy or position of Test Labs Limited. The content provided is for informational purposes only and is not intended to constitute legal or professional advice. Test Labs assumes no responsibility for any errors or omissions in the content of this article, nor for any actions taken in reliance thereon.