Mastering the ANVISA Medical Device Registration Process in Brazil
Summary
This article outlines the essential steps and considerations for manufacturers and importers aiming to navigate the regulatory landscape for medical devices in Brazil. It emphasizes the importance of classifying devices correctly, as the classification determines the registration process's complexity and documentation requirements. Class I and II devices can utilize a simplified notification pathway, while Class III and IV devices require thorough evaluations and inspections.
Additionally, the article highlights the necessity of maintaining active registrations and licenses to avoid legal issues and maintain credibility with healthcare providers and consumers. Staying updated on ANVISA’s evolving regulations is crucial for successful market entry.
In closing, the article encourages readers to seek professional assistance from bioaccess®, a specialized Medtech contract research organization (CRO) in Brazil, to navigate the registration process efficiently and effectively.
Navigating the labyrinth of medical device regulations can be daunting, especially when entering a market as intricate as Brazil's. With a burgeoning healthcare sector and increasing demand for innovative medical technologies, understanding the registration process with ANVISA (the Brazilian Health Regulatory Agency) is crucial for success.
ANVISA plays a pivotal role in ensuring that medical devices meet safety and efficacy standards before they reach Brazilian patients. Recognizing the different classifications of medical devices and the respective registration requirements is essential for manufacturers aiming to facilitate smooth entry into this vibrant market.
This article will unravel the complexities of the ANVISA medical device registration process, providing a detailed roadmap for manufacturers at all stages. From pre-registration necessities to the intricacies of various device classifications, we aim to equip you with the knowledge needed to master ANVISA's requirements and ensure compliance.
Understanding ANVISA and its Role
Navigating the Brazilian market for medical devices requires understanding ANVISA's role. ANVISA, the National Health Surveillance Agency, handles the classification and approval of these devices in Brazil. Its main goal is to ensure safety and effectiveness by adhering to Law 6360/1976.
Medical devices are grouped into four categories based on risk:
This classification affects the registration process. Each class requires different levels of data submission and review rigors. Applicants must provide detailed device information, clinical data, and agree to post-market surveillance.
To speed up access to new technologies, ANVISA has introduced the Reliance Pathway. This allows ANVISA to consider assessments from foreign regulatory agencies, streamlining the review and approval processes. ANVISA's stringent requirements can be complex, but understanding them is key to entering and succeeding in the Brazilian medical device market. By aligning with these standards, businesses can ensure they meet all legal and ethical requirements necessary for registration and market entry.
Overview of Medical Device Categories in Brazil
Navigating medical device regulations in Brazil requires understanding how ANVISA, the Brazilian Health Regulatory Authority, classifies and approves these products. Medical devices here can range from simple instruments to complex in vitro diagnostic tools and healthcare software. ANVISA classifies these devices into four categories based on risk:
Classes I and II follow the simplified registration process, known as Notificação. Conversely, Classes III and IV require the comprehensive Registro process. All devices must comply with safety and compliance outlined in ANVISA Resolution RDC 751/22.
Key requirements include:
Detailed technical documentation
Compliance with specific labeling standards found in Chapter VI of RDC 751/22
By understanding these classifications and processes, companies can better navigate the stringent regulatory requirements in the Brazilian market.
Classification System for Medical Devices
Navigating the classification system for medical devices in Brazil is a crucial first step in the ANVISA registration process. ANVISA, Brazil’s National Health Surveillance Agency, classifies devices into four categories based on risk:
Class I and II devices go through a simpler notification process and have fewer document requirements. They can maintain indefinite registration validity if they stay compliant and are actively marketed.
In contrast, Class III and IV devices require a more thorough registration path. This includes obtaining B-GMP certification, which involves on-site inspections.
The classification ensures that devices meet specific safety and efficacy standards. Understanding this system helps companies comply with Brazilian regulations and successfully enter the Brazilian market.
This structure allows appropriate risk analysis, ensuring that all medical devices are safe for the public.
Pre-registration Requirements for Manufacturers
Before registering medical devices in Brazil, manufacturers must meet several pre-registration requirements. First, correctly classify the device. Class I and II devices go through the simplified Notificação process. Class III and IV devices require the more detailed Registro process, which needs a Technical File with clinical data.
Next, appoint a Brazil Registration Holder (BRH). This person acts as the manufacturer's legal representative in Brazil and holds the regulatory license.
Manufacturers must compile a comprehensive technical dossier, including:
Legal documents
Labeling information
Risk analysis
All documents must be translated into Portuguese to meet ANVISA's labeling rules.
Here's a quick classification summary:
For Class III and IV devices, start renewals no earlier than one year and no later than six months before the registration expires. Meeting these requirements ensures a smooth submission to ANVISA via the BRH.
Designating a Local Legal Representative
Designating a Local Legal Representative is crucial for foreign manufacturers entering the Brazilian market. According to ANVISA regulations, all foreign medical device manufacturers must appoint a Brazil Registration Holder (BRH). This local representative acts as the legal face in Brazil, handling submissions, notifications, and any reports of adverse events to ANVISA.
Here's a quick checklist:
Appoint a BRH: They act as your legal representative in Brazil.
Handle Regulatory Submissions: BRH manages all forms and notifications.
Manage Adverse Event Reports: Ensures safety updates are reported promptly.
Ensure Compliance: Translates and adapts documentation to meet local standards.
Electromedical equipment requires additional INMETRO certification. This certification, alongside having a BRH, ensures full compliance with Brazilian laws. Without a BRH, you cannot get the crucial ANVISA authorization needed for the commercialization, importation, and distribution of medical devices in Brazil.
Thus, the BRH ensures that all labeling and documentation are in Portuguese and align with local legal requirements, facilitating a smoother entry into the Brazilian healthcare market.
Overview of the Registration Process
Navigating ANVISA's registration process for medical devices in Brazil begins with determining your device's classification. Devices fall into four classes: I, II, III, or IV, based on risk levels.
Here's a quick overview:
Steps to Register Your Device:
Classify Your Device: Determine if it's Class I, II, III, or IV.
Appoint a BRH: Choose a Brazilian Registration Holder, who must hold a Company Working Allowance permit from ANVISA.
Compile Documentation: For higher classes (III and IV), include clinical data and proof of GMP certification.
Submit Application: Provide ANVISA with a complete technical dossier, including general device info and proof of free sale.
Remember, Class I and II devices follow a simplified route with fewer requirements, while Class III and IV devices require a more rigorous process.
Specific Registration Steps for Class I Devices
Navigating the registration process for Class I medical devices in Brazil involves a simpler path compared to higher-risk classes. The Notificação route is used for Class I devices as they are considered low risk. Here are the key steps for registration:
Application Submission: Manufacturers must submit an application and required documents to ANVISA, although ANVISA does not review these applications.
Technical Dossier: A comprehensive technical dossier is required. This should be kept by the Brazil Registration Holder (BRH) and available for possible ANVISA inspections.
Continuous Registration: Class I device registrations do not expire, allowing ongoing market presence without needing periodic renewals.
Focus on Efficiency: This simplified path lets ANVISA focus on higher-risk devices, streamlining the process for low-risk products.
This approach emphasizes efficiency and ensures Class I devices remain available without frequent renewals.
Detailed Steps for Class II Device Registration
Navigating the Class II device registration process in Brazil involves several important steps. Understanding these steps ensures compliance with ANVISA, the National Health Surveillance Agency.
Here are the key steps:
Appoint a Brazil Registration Holder (BRH): This is mandatory for foreign manufacturers. The BRH handles the submission of necessary documents to ANVISA.
Prepare a Technical Dossier: While the documentation requirements are minimal, you must prepare a comprehensive technical dossier. The BRH maintains this dossier for potential ANVISA inspections.
Notification Registration Process: Class II devices, considered medium-risk, undergo a notification registration process. This process typically takes about 30 days.
Ongoing Compliance: Once registered, Class II device registrations do not expire as long as the product remains compliant and is actively marketed.
Advantages of Class II Registration:
No upfront Good Manufacturing Practices (GMP) certification is required.
Streamlined documentation makes the process quicker.
By following these steps, manufacturers can ensure a smooth registration process for their Class II medical devices in the Brazilian market.
Navigating Class III Device Registration Procedures
Navigating the registration process for Class III medical devices in Brazil involves strategic planning. Here’s a brief guide to help you out:
1. Technical Dossier Preparation:
A comprehensive dossier is essential.
It must include clinical data.
CE marking or FDA registration can simplify this step.
2. Compliance and Certification:
Obtain Brazilian Good Manufacturing Practices (BGMP) certification.
ANVISA conducts an on-site inspection for BGMP.
3. Registration Validity:
Registration lasts for 10 years.
Ensure continual compliance with ANVISA’s standards.
4. Ongoing Post-Market Surveillance:
Continuous monitoring is mandatory.
Report any adverse reactions.
Key Points to Remember:
ANVISA’s requirements are rigorous; detailed submissions are crucial.
Familiarize yourself with ANVISA's regulatory framework.
Utilize pre-existing certifications to ease the process.
Understanding and preparing for these steps ensures a smoother journey through ANVISA’s regulatory landscape for Class III devices in Brazil.
Understanding Class IV Medical Device Requirements
Navigating the regulatory landscape for Class IV medical devices in Brazil can be challenging. These devices are considered maximum risk by ANVISA, Brazil’s National Health Surveillance Agency. Here’s a quick guide to help you understand the requirements:
Key Requirements:
B-GMP Certification: Manufacturers need this certification. ANVISA conducts on-site inspections of manufacturing facilities.
Technical Dossier: A comprehensive technical dossier is essential. It must include clinical studies, device information, instructions for use, proposed labeling, and necessary legal documents.
Registration Validity: The registration for Class IV devices lasts 10 years. After this period, re-application is necessary.
Brazil Registration Holder (BRH): Manufacturers must appoint a BRH to manage the registration process with ANVISA. This ensures the maintenance and control of the device registration.
In summary, Class IV medical devices require detailed submissions and adherence to stringent requirements. Appointing a BRH can facilitate the process, ensuring compliance with ANVISA’s rigorous framework for medical devices in the Brazilian market.
Brazilian Good Manufacturing Practices (BGMP)
Navigating the Brazilian Good Manufacturing Practices (BGMP) is crucial for manufacturers of Class III and IV medical devices in Brazil. The BGMP certification aligns with ISO 13485:2016 standards, ensuring high-quality manufacturing processes. Achieving this certification is key to keeping device registration and regulatory compliance under control in Brazil.
Key Points About BGMP:
Mandatory for Higher Classes: Class III and IV devices require BGMP to attain registration.
International Standards: Compliance is consistent with ISO 13485:2016.
Market Entry: BGMP simplifies entering the Brazilian market.
Regulatory Compliance: Helps in navigating regulatory challenges.
Strategy Impact: The certificate's validity period can influence device manufacturing and marketing strategies.
Obtaining BGMP certification is not just a regulatory requirement; it is a strategic step toward market success. Manufacturers must prioritize this to address Brazil's stringent requirements and optimize their market entry strategy. Keep in mind that the certificate's validity may impact long-term planning, so staying informed on regulations is vital.
Documentation Required for ANVISA Registration
Navigating the ANVISA registration process requires thorough preparation. Manufacturers must gather essential documents to meet Brazil's stringent regulatory requirements. Here’s a quick guide on what you need:
Product Information: Detailed descriptions, including manufacturing processes and labeling details, must be compiled.
Technical Specifications: Clear technical data about the device is necessary to assist in the approval process.
Safety Data Sheets: These are crucial to ensure that the device complies with relevant health and safety regulations in Brazil.
Quality Control Procedures: Documented processes highlight adherence to safety and quality standards.
Risk Analysis: This document should detail potential risks associated with using the medical device, ensuring that safety measures are in place.
Each piece must be complete and accurately presented to avoid delays in the ANVISA review process. Timely submission means understanding rigorous requirements and preparing meticulous application forms. Following these guidelines helps navigate the path to successful registration in the Brazilian market.
Prepare your documentation carefully to align with ANVISA’s regulatory framework.
Fees Associated with the Registration Process
Navigating the fees for ANVISA registration of medical devices in Brazil can be complex. The costs vary significantly depending on the device's classification and risk profile (Class I-IV). Typically, filing for a Class I device costs less due to its lower risk, whereas Class IV devices incur higher costs given the stringent requirements for registration.
Additional expenses can arise if a company decides to expedite its Good Manufacturing Practices (GMP) inspection by filing a lawsuit against the Brazilian Association of the Health Technology Industry (ABIMED). This step can affect the official fees and could shorten the inspection time from the usual 6-8 months.
Here's a quick look at potential costs:
Manufacturers should also budget for ongoing costs related to the maintenance and renewal of their registrations. This is similar to practices in other Latin American markets, such as Mexico and Colombia, where fees align with device complexity. Keep these factors in mind to effectively plan for successful market entry into Brazil.
Expected Timelines for Medical Device Registration
Navigating the ANVISA registration process for medical devices in Brazil requires understanding the expected timelines. The duration of this process can vary, often taking several months. It includes stages like application review, compliance verification, and product testing.
Standard Timelines:
New Drug Protocols: ANVISA must issue a written opinion within 45 calendar days post-submission.
Final Opinion on New Drug Registration: Provided within 120 days.
Post-Registration Petitions: Final opinion within 60 days.
Efforts to expedite approval are supported by specific criteria outlined in RDC No. 204/2017. This is designed to address significant public health needs with priority submissions.
The certification process must follow the new normative instructions effective in 2024. Each stage in the journey requires careful preparation to meet ANVISA’s stringent requirements.
Understanding these timelines and regulatory guidelines is crucial when seeking approval in the Brazilian market. Properly navigating these steps ensures a smoother process and compliance with the regulatory framework.
Post-Market Surveillance Obligations
Post-market surveillance is crucial for medical devices in Brazil. It ensures they continue to perform safely and effectively after hitting the market. Under ANVISA’s regulatory framework, companies must uphold these activities to maintain safety standards.
Key Obligations:
Monitor: Constantly track the device's performance.
Report: Document any safety information or adverse reactions.
Document: Keep detailed records of all findings.
These obligations apply to all device classes, with a focus on higher-risk devices like Class III and IV. Meeting these requirements is non-negotiable. Failing to comply could impact the device's market authorization and overall compliance with ANVISA.
Risk for Non-Compliance:
Market authorization may be affected.
Regulatory consequences could arise.
In short, thorough post-market surveillance is essential for maintaining the device's safety and effectiveness, ensuring a company's continued success in the Brazilian market.
Importance of Vigilance Reporting
Navigating the ANVISA regulatory landscape in Brazil requires a strong emphasis on vigilance reporting for medical devices. Once a product enters the Brazilian market, manufacturers must report any adverse events related to their devices. This ensures the safety and efficacy standards set by ANVISA are met.
Vigilance reporting is essential for managing risks linked to defective products. Companies must conduct thorough investigations, which can sometimes lead to recalls. Failure to report and address safety issues may result in the non-renewal of marketing authorization, threatening a company's market presence.
Key elements of vigilance reporting include:
Incident tracking: Monitoring device performance post-market.
Timely reporting: Submitting detailed reports to ANVISA.
Risk management: Implementing measures to minimize potential harm.
Effective vigilance processes help manufacturers maintain compliance throughout the product lifecycle. This allows for a swift response to any safety concerns, reinforcing trust in their medical devices both in Brazil and the broader Latin American market.
Special Labeling Requirements in Brazil
Navigating the labeling requirements for medical devices in Brazil can be complex. These rules are set by ANVISA to ensure all medical devices in the Brazilian market comply with national standards. Labels must be in Portuguese and can include symbols and warnings to help users.
Key Labeling Elements for Investigational Products:
Sponsor name
Pharmaceutical form
Route of administration
Quantity of dosage units
Essential clinical trial information
For investigational products, labels must display phrases like "EXCLUSIVE USE IN CLINICAL TRIALS" and "KEEP OUT OF REACH OF CHILDREN" in capital letters. These must be clear and easy to see.
A Brazilian Good Manufacturing Practices (BGMP) Certificate must also be considered in labeling when applicable. This reinforces a commitment to Brazil's regulatory compliance.
Example Label Elements:
By adhering to these guidelines, you can ensure your medical devices meet Brazil's stringent regulatory requirements.
Common Challenges in the Registration Process
Navigating the ANVISA registration process for medical devices in Brazil presents several challenges for companies, especially foreign manufacturers. A key hurdle is the classification of devices. Class I and II enjoy a simplified process, while Class III and IV undergo rigorous requirements, including Good Manufacturing Practices (GMP) certification.
Foreign companies face the challenge of needing a national registration holder authorized by Brazilian sanitary bodies. This necessity often complicates entry into the Brazilian market. Additionally, costs are unpredictable due to varying official fees and timelines. Legal actions, such as filing lawsuits against ABIMED regarding GMP inspections, can further influence these costs.
Companies must also budget for additional expenses throughout the registration journey. These costs include pre- and post-marketing activities like product certifications, documentation translation, and pharmacovigilance to monitor adverse reactions.
Common Challenges:
Complex device classification
Need for a national registration holder
Unpredictable costs and timelines
Additional expenses (certifications, translations, pharmacovigilance)
Successfully navigating these obstacles requires a thorough understanding of Brazil's regulatory landscape and strategic planning for entry into the Latin American market.
Tips for a Successful Registration Experience
Navigating the ANVISA registration process for medical devices in Brazil can be challenging. Here are some tips for a successful registration experience:
Understand Device Classification:
Medical devices are classified into four categories: Class I, II, III, and IV.
Class I and II follow a simpler Notification process.
Class III and IV require a detailed Registro process and Good Manufacturing Practices certification.
Leverage International Registrations:
Previous CE marking or FDA registration can ease the process for Class III and IV devices.
Use ANVISA’s Reliance Pathway to benefit from assessments by recognized foreign authorities.
Prepare Comprehensive Submissions:
Ensure all device information is detailed and accurate.
Include a risk analysis and product testing data.
Plan for Post-Market Surveillance:
Establish a protocol for ongoing monitoring of safety and effectiveness.
Collaborate with Experts:
Consider partnering with a CRO or an Importer of Record to navigate the regulatory landscape.
Here's a quick look at the classification requirements:
Following these steps can streamline your journey through Brazil’s regulatory landscape.
The Role of Third-Party Consultants
Navigating ANVISA's regulatory journey for medical devices in Brazil can be complex. Third-party consultants play a crucial role in this process by offering expertise and guidance. They help companies with the Brazilian Good Manufacturing Practice Certificates (GMPCs) and the Medical Device Single Audit Program (MDSAP) certification.
Consultants ensure that all necessary technical and clinical data is properly prepared for ANVISA’s review. This is essential for the approval of medical devices. Without a BGMP certificate, applications remain pending, so consultants help in obtaining these essential certifications.
A list of tasks that third-party consultants assist with includes:
Preparing comprehensive documentation for ANVISA.
Offering accurate guidance on dossier submissions for devices approved by multiple authorities.
Navigating the Reliance Pathway to leverage foreign regulatory assessments.
Consultants’ expertise is vital in prioritizing submissions when multiple dossiers are involved. They provide necessary post-market support and ensure compliance with ANVISA’s stringent requirements. By working with third-party consultants, medical device companies in Brazil can achieve faster and smoother market access.
Resources for Staying Updated on Regulatory Changes
Navigating regulatory changes in Brazil's medical device market requires staying updated with ANVISA’s requirements. The Brazilian National Health Surveillance Agency, ANVISA, is responsible for evaluating medical devices. They collaborate with international bodies, like the U.S. FDA, to align their standards.
One useful resource is ANVISA’s Reliance Pathway, as outlined in RDC 741/2022. This pathway allows them to consider assessments from trusted foreign agencies. This streamlines the evaluation process, making it easier for companies to get their products to market.
To ensure compliance, maintaining investigatory records post-marketing is crucial. This includes adhering to specific requirements based on the medical device category.
Local authorized representatives, such as bioaccess®, play a key role in regulatory navigation. As a leading contract research organization (CRO) in Latin America, they help companies adjust to changes and meet ANVISA's evolving requirements.
Resources for Staying Updated:
ANVISA’s website for official guidelines and updates.
Engaging with local regulators or representatives.
Collaborating with a local CRO like bioaccess®.
Joining industry networks and forums for peer insights.
Staying informed is essential for success in the Brazilian market.
Conclusion and Next Steps
Navigating ANVISA's regulatory approval for medical devices in Brazil is complex. Yet, understanding the process is key.
Here's a brief overview of critical steps ahead:
Device Classification: Determine if your device is Class I, II, III, or IV. Each class has unique requirements.
Appoint a Brazil Registration Holder (BRH): This is crucial for foreign manufacturers. The BRH submits and manages your applications.
Prepare Documentation: Class III and IV devices need a comprehensive Technical File, including clinical data.
InMETRO Certification: Check if your device needs this, especially for electro-medical devices.
Registration Application: Ensure all documents are complete and correctly submitted.
Monitor Expiry: Class III and IV registrations expire in ten years—plan for renewal.
Consider conducting a risk analysis and ensure all ethical standards are met. Also, develop standard operating procedures for post-market surveillance to monitor adverse reactions. Stay informed about Brazil's regulatory framework and maintain contact with ANVISA and other regulatory agencies. These steps will guide you on the path to successful market entry in Brazil.
FAQs
What types of medical devices require ANVISA registration?
ANVISA classifies medical devices into four risk levels:
Class I (Low Risk)
Class II (Medium Risk)
Class III (High Risk)
Class IV (Maximum Risk)
For Class I and II devices, a simple notification, termed "Notificação," suffices. This streamlined process involves submitting basic information to ANVISA.
Class III and IV devices face a more rigorous registration process, known as "Registro." This includes detailed technical dossiers and clinical data submissions. Additionally, manufacturers of Class III and IV devices must secure B-GMP certification. This involves on-site inspections to ensure compliance with Good Manufacturing Practices. Note that registration for these devices is valid for ten years, provided all regulations are continuously met.
How long does the ANVISA registration process typically take?
The ANVISA certification process duration can vary. It depends on factors such as product complexity and documentation accuracy. The current ANVISA workload also plays a role. On average, certification may take several months. This period includes application review and compliance verification. For priority products, after submitting a request for prioritization analysis, ANVISA has a maximum of 120 days to decide.
Completeness of documentation can greatly impact the efficiency of the review process. Thus, ensuring accurate documentation is crucial for timely compliance and successful product entry into the Brazilian market.
Are there penalties for non-compliance with ANVISA regulations?
Non-compliance with ANVISA can have serious repercussions. Holders of market authorizations must report to SNVS if their device causes serious public health threats. This includes instances leading to deaths or significant adverse events. Manufacturers or importers bear regulatory, civil, and criminal responsibilities. Failing to comply with ANVISA can result in legal consequences.
A company must have a sanitary license from local authorities and a permit from ANVISA to manufacture, import, export, or distribute medical devices. Failure to comply can lead to penalties or enforcement actions.
Licenses must be renewed annually. Failure to maintain valid licenses can lead to penalties or suspension of operational authority. Breaches of compliance can result in fines or sanctions, reflecting ANVISA's emphasis on responsibility and accountability for regulatory decisions.
What types of medical devices require ANVISA registration?
Navigating the ANVISA registration process in Brazil depends on the device's risk classification. Here's a breakdown:
Class I and II Devices:
These devices follow a simplified notification process known as Notificação. It's a straightforward application that requires minimal documentation.
Class III and IV Devices:
These require the more rigorous Registro process. Manufacturers must submit detailed technical dossiers and clinical data. Additionally, B-GMP certification is required, which involves on-site inspections to ensure compliance with Good Manufacturing Practices.
The registration for Class III and IV devices is valid for ten years. However, compliance with ANVISA regulations must be maintained to keep the registration active.
In summary, understanding the classification of your medical device is crucial for determining the necessary ANVISA registration steps.
Conclusion
Navigating the ANVISA regulatory registration process for medical devices in Brazil is a complex but essential journey for manufacturers and importers looking to enter this lucrative market. Understanding the classification of your device is pivotal, as it dictates the level of scrutiny and documentation required for registration. While Class I and II devices benefit from a simplified notification process, Class III and IV devices necessitate a more comprehensive approach, including rigorous technical evaluations and inspections to ensure compliance with quality standards.
Moreover, maintaining an active registration and the necessary licenses is critical to avoid legal repercussions and operating penalties. Investing time and resources into understanding and complying with ANVISA's regulations not only facilitates smoother market entry but also helps in fostering trust and credibility with healthcare providers and consumers.
As the regulatory landscape continues to evolve, staying informed about ANVISA's requirements and being proactive in your compliance efforts will prepare your organization for success in the Brazilian medical device market. By mastering the ANVISA registration process, you position your company not just as a compliant player, but as a leader in innovation and safety within the healthcare sector.
Are you ready to streamline your journey through the ANVISA regulatory registration process for your medical devices? Don’t navigate this complex landscape alone. Contact bioaccess® today – the only specialized Medtech CRO in Brazil that understands the intricacies of the Brazilian regulatory environment. Our expert team is dedicated to guiding you through each step, ensuring you meet all requirements efficiently and effectively.
Whether you're seeking assistance with documentation, technical dossiers, or compliance strategies, bioaccess® is here to help you achieve a successful market entry. Reach out now to learn how we can support your aspirations in the Brazilian medical device market and position your company for lasting success!