Bringing a medical technology into Brazil involves much more than logistics and commercialization.
Behind every device lies a complex and essential regulatory chain, designed to ensure that products reach healthcare professionals, and ultimately patients, with safety, effectiveness, and full traceability.
This journey, which begins with the manufacturer and ends at the clinical application, is carefully structured and supervised by Anvisa, Brazil’s National Health Surveillance Agency.
Understanding each stage of this process is the first step toward operating successfully and sustainably in the Brazilian market.
- Development and Technical Validation
The regulatory journey begins at the product development stage, often in the country of origin.
At this point, manufacturers perform performance tests, safety validations, and clinical evaluations (when applicable) to demonstrate compliance with international standards such as ISO 13485 and IMDRF guidelines.
These documents form the foundation of the regulatory dossier that will later be submitted to Anvisa.
The stronger this technical foundation, the more predictable and efficient the approval process becomes.
- Legal Representation in Brazil
To apply for registration, the manufacturer must appoint a legal representative in Brazil, responsible for managing the process with Anvisa and maintaining post-approval compliance.
This representative acts as the key communication link between the manufacturer, the regulatory authorities, and local stakeholders.
At Brisa, this function is embedded within an integrated ecosystem that combines legal representation, importation, and regulatory intelligence by giving manufacturers full governance and transparency over their products.
- Product Classification and Submission to Anvisa
The first official step in the regulatory process is the risk classification of the medical device, in accordance with RDC 751/2022.
Based on this classification, the product will follow one of two regulatory pathways:
Notification – for Class I and II devices, considered low or medium risk. This streamlined process focuses on documentary evidence, labeling, and quality system certification.
Registration – for Class III and IV devices, considered high or maximum risk. This pathway requires a comprehensive technical dossier, including clinical data (when applicable), risk analysis, and proof of Good Manufacturing Practice (GMP) certification.
Upon approval, the product receives a unique registration number, authorizing its importation, distribution, and commercialization throughout Brazil.
- Importation and Sanitary Clearance
Once registered, each product must undergo import authorization and sanitary clearance through Anvisa and the Brazilian Federal Revenue Service.
This stage ensures that every imported batch maintains full traceability, integrity, and compliance with the approved regulatory conditions.
Here, the integration between regulatory consulting and logistics operations becomes crucial and represents one of Brisa’s core differentiators.
- Distribution and Traceability
After clearance, the product enters the distribution phase, governed by RDC 665/2022, which establishes strict requirements for storage, transportation, and traceability.
Every unit must be traceable back to its origin, ensuring that any nonconformity can be rapidly identified and resolved.
Organizations that manage this phase efficiently deliver not only compliance but also market credibility and patient safety.
- Clinical Use and Post-Market Surveillance
The final stage of the journey occurs in the clinical setting, where the device is used by healthcare professionals.
Even after market entry, regulatory obligations continue: the registration holder must monitor adverse events, handle technical complaints, and periodically update product documentation.
This ongoing surveillance ensures that the device maintains its safety and performance throughout its entire lifecycle.
A Journey that Demands Strategy
Each stage of the regulatory process, from design to clinical use, requires planning, technical expertise, and integrated management.
Companies that view regulation as part of their innovation strategy can reduce time to market, optimize costs, and accelerate patient access to new technologies.
At Brisa, we’ve structured our regulatory ecosystem to accompany this complete journey, ensuring that every product moves from manufacturer to patient with efficiency, compliance, and trust.
Find out more about BPO in RA!
*Budget for registration ownership transfer, Market Access Strategy, and BPO in RA services for your company: www.brisa.com.br
