The new article addresses aspects related to the way the authority’s consent should be obtained prior to importing medical devices to Brazil.

Brazilian Health Regulatory Agency: ANVISA

The Brazilian regaling authority in the sphere of healthcare products (ANVISA), has published a guidance document dedicated to the rules, requirements, and procedures associated with the importation of medical devices. The document provides an overview of the existing regulatory framework, as well as additional clarifications and recommendations to be considered by medical device manufacturers, importers, and other parties involved in order to ensure compliance with the applicable regulatory requirements when importing medical devices to Brazil. At the same time, provisions of the guidance are non-binding in their legal nature, and they are intended to introduce new rules or impose new obligations. The authority also reserves the right to make changes to the guidance and recommendations provided therein, should such changes be reasonably necessary to reflect corresponding changes to the underlying legislation. 

The scope of the guidance covers, inter alia, regulatory matters related to the way an interested party may obtain consent from the authority for the importation of a medical device.

ANVISA Registration

According to the guidance, the first step should be to register a company with ANVISA in order to be able to access the regulatory services provided by the authority. Under the general rule, registration requirements apply to any and all entities interested in importing medical devices, both public and private. The authority has developed and published detailed step-by-step instructions available on its website describing the way such a registration should be completed. The registration holders are obliged to ensure the information uploaded to the system is always accurate and up-to-date. This applies to their subsidiaries as well, provided these subsidiaries are also subject to registration. It is important to mention that registration requirements also apply to entities intended to import medical devices under one of the exemptions set forth under the existing legal framework. 

The authority additionally emphasizes that should any discrepancies be identified within the information provided, the appropriate notice will be issued to the registration holder, resulting in potential delays with the customs clearance of the products to be imported.

Request System

As further explained by the authority, all the filings should be performed via its electronic filing system – Solicita. The system allows for company details to be associated with the relevant data, including information about payments associated with the fees. In order to assist interested parties with using the system, the authority has published two educational webinars together with questions-and-answer documents and presentations addressing the most important aspects associated with the use of the said system when submitting regulatory requests.

Inspection Fee

According to the guidance, a request for import permission (consent) from the authority should be requested via the Solicita system. Depending on such factors as the applicable product category, the purpose of import, mode, type, and size of the importer, the appropriate fee will become payable by the interested party – the Inspection Fee of Sanitary Surveillance. The appropriate requirements are set forth by RDC n. 222/2006 and Law n. 9782/1977.

Subject Code

The authority mentions that the appropriate numeric code will be used to ensure the traceability of requests related to importation. Such a code will be linked to the product in question, and its assignment will also trigger the fee payment obligations described hereabove. The code should be assigned via a special system, for which the authority also provides additional clarifications and instructions for use.

Document Execution

According to the guidance, all the documents associated with the planned importation of medical devices should be electronically signed with a respective digital certificate. 

In summary, the present document describes the way an interested party should apply for and obtain the authority’s consent for the importation of medical devices. According to the guidance, the applicable process should be as follows:

  1. Apply for registration of the entity itself (establishment registration) to be able to access the regulatory services. Ensure that all the information provided is correct and accurate. 
  2. Submit a request for importation permission (consent) via the appropriate online filing system. The subject code should be used to ensure the traceability of the application and its connection to the device. The system will automatically link the application to the registration of the responsible entity. 
  3. Once the request is submitted and the appropriate product code is assigned, the respective inspection fee will become due. The specific amount payable would be calculated based on the product in question and various factors associated with it. 

The guidance provides additional clarifications regarding the aforementioned aspects and highlights the key points associated with them.

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