Brazilian Certification for Medical Devices Services
Certification from INMETRO (Instituto Nacional de Metrologia, Qualidade e Tecnologia) is mandatory for electrical medical devices sold in Brazil. Governed by Portaria 54/2016, this certification ensures compliance with Brazilian safety standards, guaranteeing reliable and safe use within the healthcare system. At Hegemoni Regulatory & Business Solutions, we provide Brazilian Certification for Medical Devices Services, helping clients navigate the testing, documentation, and submission processes for seamless compliance.
What We Do:
Our INMETRO certification services are designed to simplify the process of certifying medical devices with electrical components. These services include:
- Regulatory Assessment: Evaluating your medical devices to identify applicable INMETRO standards and requirements.
- Testing Coordination: Arranging and overseeing laboratory testing to confirm compliance with Brazilian safety protocols.
- Documentation Preparation: Preparing and submitting all required technical dossiers, including test reports and product specifications, to INMETRO.
- Certification Submission: Managing the application process and liaising with INMETRO to ensure timely certification.
- Ongoing Compliance Support: Monitoring regulatory updates and advising on maintaining certification for continued market access.
Our comprehensive support ensures your medical devices meet all INMETRO requirements, facilitating safe and reliable use within the Brazilian healthcare system.
How We Add Value:
At Hegemoni Regulatory & Business Solutions, we streamline the INMETRO certification process, reducing delays and ensuring compliance with Portaria 54/2016. Our expertise minimizes risks, enabling your devices to meet Brazil’s high safety standards and gain trust in the healthcare market.
Why Choose Hegemoni Regulatory & Business Solutions?
With extensive experience in INMETRO certification and medical device compliance, we have successfully assisted clients in achieving certification for a wide range of products. Our personalized approach ensures your devices are certified efficiently and meet all safety and technical standards for Brazilian market entry.
Take the Next Step:
Schedule a Free Consultation:
Ready to certify your medical devices with INMETRO? Visit our Contact Page to schedule a free consultation with our team today! Let us help you navigate the certification process under Portaria 54/2016 and ensure compliance with Brazilian technical standards.
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