Brazilian Medical Device Registration Services
Medical device registration in Brazil is governed by ANVISA’s RDC 185/2001 and RDC 36/2015, which classify devices based on their risk and intended use. Ensuring compliance with these standards is essential for legal market entry and safe usage within the healthcare system. At Hegemoni Regulatory & Business Solutions, we provide Brazilian Medical Device Registration Services, offering end-to-end guidance to streamline the registration process and align with ANVISA’s safety and efficacy requirements.
What We Do:
Our comprehensive medical device registration services include:
- Device Classification: Determining the appropriate risk class for your medical device (Classes I to IV) based on ANVISA’s criteria.
- Risk Assessment: Evaluating potential risks associated with the device’s use and ensuring compliance with regulatory requirements.
- Application Preparation: Assisting with the preparation and submission of technical dossiers, clinical data, and other required documentation to ANVISA.
- Regulatory Filings: Managing the registration process, including submission and follow-up with ANVISA to secure approvals.
- Ongoing Compliance Support: Monitoring regulatory updates and ensuring continued compliance for registered devices.
Our tailored approach ensures your medical devices meet ANVISA’s rigorous standards, enabling timely market entry and trust within Brazil’s healthcare sector.
How We Add Value:
At Hegemoni Regulatory & Business Solutions, we simplify the complexities of medical device registration, reducing risks of delays or rejections. Our expertise ensures compliance with ANVISA’s standards while streamlining the process, allowing your devices to meet the needs of the Brazilian healthcare market effectively.
Why Choose Hegemoni Regulatory & Business Solutions?
With extensive experience in medical device registration and ANVISA compliance, we have successfully guided clients across the medical industry in achieving regulatory approval. Our personalized services ensure your devices comply with legal standards while supporting safe and effective healthcare solutions.
Take the Next Step:
Schedule a Free Consultation:
Ready to register your medical devices in Brazil? Visit our Contact Page to schedule a free consultation with our team today! Let us help you navigate ANVISA’s registration process under RDC 185/2001 and RDC 36/2015 for streamlined market access.
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