Registering a medical device in Brazil involves a series of specific steps mandated by the Brazilian Health Regulatory Agency (ANVISA). This guide outlines the process, timelines, and key considerations for developing regulatory strategy in Brazil
Step 1: Device Classification
ANVISA classifies medical devices into four categories: Class I, II, III, and IV, based on risk to patients and users. Each classification follows a distinct registration pathway:
Class I & II Devices (Low Risk): These follow a notification (Notificação) process that takes about 30 days. The documentation requirements are minimal and do not require an upfront GMP (Good Manufacturing Practices) certification. This simplified process ensures indefinite registration validity, so long as the product remains compliant and actively marketed.
Class III & IV Devices (High Risk): Higher-risk products follow the registration (Registro) pathway, requiring a more thorough technical dossier and clinical data. ANVISA mandates B-GMP certification, involving on-site inspections at manufacturing facilities.
Timeline: 8 to 15 months
Validity: 10 years, with renewal required at least six months before expiration.
Managing expectations around timelines, particularly for high-risk devices, is crucial for effective market entry planning.
Step 2: BGMP- Brazilian Good Manufacturing Practice
For devices which fall into the high-risk classification, BGMP is a mandatory step. There are two possible pathways to this:
On-Site Audit: This involves a direct evaluation of the manufacturer’s facilities and processes. ANVISA conducts a thorough assessment to ensure compliance with quality management system (QMS) requirements and regulatory standards.
MDSAP Audit Report Analysis: In this pathway, ANVISA reviews the manufacturer’s QMS documentation or the findings from an MDSAP (Medical Device Single Audit Program) audit report. ANVISA collaborates with Australia, Canada, Japan, and the United States to enable this process.
Step 3: Appointing a Legal Representative
In Brazil, foreign manufacturers must appoint a Brazilian Registration Holder (BRH), which serves as the legal representative for the registration process. The BRH holds the regulatory license and is responsible for post-market surveillance and compliance.
While regulatory processes are very similar to what we saw in last week’s Argentina registration guide, here is where we encounter a key difference. Unlike in Argentina, in Brazil the registration holder may give permission to 3rd parties to import the products. For the manufacturer this can allow more control over the import process, and a stronger position on the commercialization of the product.
Step 4: Preparing Documentation
Once a BRH is appointed, manufacturers must compile the necessary documentation for their device registration. This includes, but is not limited to:
Technical documentation: Details about the design, manufacturing process, and intended use of the device.
Quality Management System (QMS) certification: Evidence that the manufacturer follows Good Manufacturing Practices (GMP).
Risk analysis: A detailed assessment of potential risks associated with the device.
Step 5: Submission to ANVISA
After preparing the required documentation, the BRH submits the application to ANVISA. It is crucial to ensure that all documents are complete and accurately presented to avoid delays.
Step 6: Review Process
ANVISA conducts a thorough review of the submitted documentation. Depending on the classification of the device, this process may involve additional queries or requests for further information. Manufacturers should be prepared for potential back-and-forth communication with ANVISA.
Step 7: Approval and Post-Market Surveillance
Upon approval, the device will receive a registration number, allowing it to be marketed in Brazil. However, the responsibilities of the BRH do not end here. They must also ensure compliance with post-market surveillance requirements, including monitoring the device’s performance and reporting any adverse events to ANVISA.
Conclusion: How LAMA Can Support Your Medical Device Registration in Brazil
Navigating the regulatory landscape for medical device registration in Brazil can be complex, but LAMA Access is here to help. With a deep understanding of the Brazilian healthcare regulatory environment and the experience of our interdisciplinary team, we can guide you through each step of the registration process, ensuring compliance with ANVISA’s requirements.
Our services include appointing a qualified Brazilian Registration Holder (BRH) to streamline your registration and maintain compliance throughout the product lifecycle. Additionally, we assist in preparing the necessary documentation, from technical files to quality management system certifications, tailored to your specific device and classification.
By leveraging our local expertise and network, LAMA Access helps you minimize potential delays and navigate the complexities of post-market surveillance obligations. Our holistic approach not only facilitates successful registration but also positions your medical device for long-term success in the Brazilian market.
For more information on our services and how we can support your journey in Brazil, contact LAMA Access today. Together, we can turn regulatory challenges into opportunities for growth and innovation in the Latin American healthcare landscape.
Stay tuned as we continue our series next week with a look at medical device registration in Colombia.
If you’re considering expanding your brand into the LATAM market, our consultancy is here to support you every step of the way, including in the exciting realm of nanomedicine and cosmetics. Together, we can unlock the full potential of your brand in this vibrant and growing market.