"Streamlining Your Regulatory Pathway for Medical Devices in Brazil with Expert Guidance"
Navigating the Brazilian market for medical devices and in vitro diagnostics can be complex due to stringent regulatory requirements. Our expert consultation services offer comprehensive support to ensure successful market entry. With in-depth knowledge of RDC 771/2022 for medical devices and RDC 830/2023 for in vitro diagnostics, we provide tailored guidance on regulatory compliance, documentation preparation, and submission processes. Our goal is to equip you with the expertise and support needed to achieve regulatory approval and maintain compliance, ensuring your products successfully reach the Brazilian market.
Our Services
Regulatory Strategy and Consultation
Provide expert guidance on regulatory pathways, submissions, and compliance strategies for Brazilian market.
Navigate complex regulations of RDC 771/2022 and RBC 830/2023.
Regulatory Submissions Support
Ensuring compliance to regulatory requirements. Prepare and review technical file for device application.
Provide support in appointing Authorized Representative for manufacturers lacking legal presence within Brazil for a smooth entry into the market.
Product classification and Labeling
Assist in product classification according to Brazil’s regulatory requirements.
Develop compliant product labels, Instructions for Use (IFUs), and packaging inserts.
Gap Analysis
In-depth assessment of your current technical documentation, and compliance practices against the relevant regulatory standards.
Identify deficiencies in Technical Files, DMRs, DHRs, and labeling.
Develop a customized plan to bridge gaps.
Testing Requirements and Safety Assessment
Discover the testing essentials for your device, including biocompatibility testings, electrical safety testings, and clinical evaluations, receiving guidance on the precise safety and performance standards best suited to its specific type.
Risk Assessment and Mitigation
Implement risk management processes based on ISO 14971. Identify, assess, and mitigate risks associated with medical devices.
Develop risk management plans to ensure product safety and regulatory compliance.
Post-Market Support
Provide support to implement processes for post-market surveillance, complaint assessments, CAPA, Medical Device Reporting and Device Recalls.
Provide comprehensive review of promotional/marketing materials and website contents in compliance with regulatory requirements
Connect With Us Now
We are eager to collaborate with you on your regulatory needs. Connect with us today for tailored solutions designed to meet your unique requirements.