Market Authorization:
Registering a Medical Device
Document Compilation -
The Technical Dossier
After defining the product’s grouping, risk class and type of registration (Notificação or Registro), it is necessary to gather the mandatory technical documents and submit them to Anvisa for evaluation.
The Technical File, also known as Technical Dossier or “Dossiê Técnico”, is the regulatory bundle that presents the medical device characteristics, intended use, mechanism of action, potential risks, manufacturing processes and additional information. It shall include IFUs, labeling, packaging, clinical information, and the List of Essential Safety and Performance Requirements (Lista dos Requisitos Essenciais de Segurança e Desempenho). This is in alignment with the International Medical Device Regulators Forum (IMDRF) guidance.
The technical dossier must be structured and organized as described in RDC 751/2022 (Annex II) and according to the product's risk class. For those RA experts who are familiar with compilation of European MDR Technical Documentation Files or IMDRF-compliant documents, this should be a similar experience; however, knowledge on device grouping and other Brazilian legal requirements is paramount.
Notification (“Notificação”)
Anvisa’s authorization for risk class I and II devices is achieved through a simplified process. The product's technical dossier, proposed labeling, and instructions for use in Portuguese, must be submitted to Anvisa for analysis. Class I and II notifications do not expire but must be reviewed periodically, as they might be canceled upon request in case of reassessment, irregularities, or when fraud is observed.
Registration (“Registro”)
Risk class III and IV medical devices must take a regulatory route which requires BGMP certification prior to product’s authorization. This includes submitting to Anvisa a complete technical dossier containing clinical data, biocompatibility studies, performance tests, etc. Class III and IV registrations are valid for 10 years and may be renewed for equal and successive periods.
After compilation of documents, the dossier (in Portuguese) must be submitted to Anvisa for approval. The submission of documents to Anvisa must be made in electronic format through Anvisa‘s Electronic Petitioning System.
Our company has the knowledge and expertise to prepare the product’s technical dossier and to assist you with every step of the preparation and submission of your application – for all risk classes! From the “easy” class I devices to the “more difficult” class IV high-risk electronic devices.
We will also accompany the progress of the petition and act proactively for fast and reliable solutions.
Responding to ANVISA's Requirements
After document submission, Anvisa will evaluate if the product’s dossier is complete and if the medical device is proven to be effective and safe.
If the Anvisa’s officers find the dossier incomplete or if any questions arise, they will issue a request called “exigencia” (requirement upon incompleteness). The next obstacle is replying to Anvisa’s requests in a timely manner, which relies majorly on the legal manufacturer’s ability to provide the documents and answers as quickly as possible.
With organized and strategic product registration, there is no doubt of successful approval in the end.
Market Authorization
When ANVISA is satisfied with the contents presented, they will approve the request and issue the market authorization (notification or registration) number for the device. This approval is published in the Official Federal Gazette (DOU).
The market authorizations for class I and II medical devices don’t expire. The product certificate for class III and IV medical devices is valid for 10 years.
Prepare Technical Dossier
We will review the technical information, intended use, and claims for your device, ensuring proper classification and grouping before beginning the registration process.
Direct Contact with Anvisa
We will communicate with Anvisa on your behalf during and after the registration process as needed.
Regulatory Strategy
Our in-depth knowledge of the Brazilian medical device market allows us to provide the most efficient and cost-effective regulatory strategy for your devices.
Monitor the Petition
Our team will closely monitor the progress of your petition and take proactive steps to ensure fast and reliable solutions.
...and much more!
Get in touch
Send us a message, we will be glad to help you through the pathway into the Brazilian market.
+55 (51) 3937-8726