Solutions
At Pro Health, we combine technical expertise, strategic vision, and a practical approach to ensure compliance, efficiency, and safety at every stage of the process before Anvisa. Check out all our solutions:
Medical Device Registrations and Notifications
We prepare and submit medical device registration and notification processes to Anvisa, including equipment, implantable and non-implantable materials, as well as IVDs, across all risk classes (I through IV).
In accordance with applicable regulatory requirements, we offer complete support to ensure your products’ compliance with current health legislation.
Our experienced team ensures efficiency, technical accuracy, and regulatory compliance at every stage.
Registration hosting
We offer a complete infrastructure, with all the necessary licenses and authorizations to ensure the secure hosting of your registration and your legal representation in Brazil.
Designating a registration holder for the registrations who is not responsible for their commercial distribution allows your company to maintain full control over the registrations in Brazil, independent of the distribution chain, enabling greater commercial flexibility.
With this approach, it is possible to appoint multiple
distributors without losing regulatory and distribution
control over your products, creating more opportunities
for your products to enter the Brazilian market.
Post-Registration Updates
We evaluate all changes related to product project after health registration in Brazil, determining whether a protocol must be filed with Anvisa to update the registration or notification of the medical device.
We ensure that every modification is reviewed before implementation, avoiding risks of non-compliance with health regulations and safeguarding the regulatory and commercial security of your product throughout its lifecycle.
Support for Companies' Health Regulatory Approval
We offer specialized guidance for the health regulatory approval of manufacturers, importers, distributors, and storage facilities of medical devices.
We provide personalized service, ensuring that each process fully meets Anvisa’s requirements, promoting legal compliance, regulatory safety, and operational efficiency at every stage.
Support and Management of Good Manufacturing Practice Certification
We conduct pre-audits to verify compliance of the Quality Management System (QMS), provide on-site support during Anvisa inspections, and assist in developing a plan to correct non-conformities identified in your QMS.
We have lead auditors who are duly certified to conduct external audits to prepare your company for national and international Anvisa inspections.
Strategic Regulatory Consulting
We offer strategic regulatory consulting to identify the best approach for regularizing your product or company in Brazil.
We evaluate your project and product type, defining customized regulatory pathways that ensure compliance with health regulations, mitigating risks, and promoting efficiency at every stage of the process.
Regulatory Feasibility Analysis
We conduct a regulatory feasibility analysis to assess the realistic possibility of submitting and obtaining approval for your product in Brazil.
We evaluate the sanitary classification and current legislation, identifying requirements, risks, and opportunities to ensure that your project is carried out efficiently and in compliance with regulations.
Regulatory Follow-Up
We continuously monitor official publications and regulatory changes that are of direct interest to your company.
We ensure that you are always updated on regulatory changes that impact your products and business, enabling you to make agile and safe decisions at every stage of your operations.
Regulatory Due Diligence
We conduct a complete preliminary investigation in the case of acquisitions of companies operating in the medical device sector.
We evaluate compliance, regulatory risks, and opportunities, providing strategic insights that support investment decisions and ensure legal and health safety throughout the process.
