The new article highlights aspects related to the importation process and documentation to be submitted by an interested party.

Brazilian Health Regulatory Agency: ANVISA

The Brazilian regulating authority in the sphere of healthcare products (ANVISA) has published updated guidance dedicated to the importation of medical devices. The document provides an overview of the applicable regulatory requirements set forth under the existing framework and also highlights the key points to be taken into consideration by medical device manufacturers, importers, distributors, and other parties involved in order to ensure compliance. At the same time, provisions of the guidance are non-binding in their legal nature and are not intended to introduce new rules or impose new obligations but rather to provide additional clarifications and recommendations. The authority also reserves the right to make changes thereto, should such changes be reasonably necessary to reflect corresponding amendments to the underlying legislation. 

In particular, the document describes the applicable importation process step by step and outlines the key points the parties involved should pay attention to.

Completing the Forms

First of all, the document describes the forms to be filled out by the interested party, explaining the information to be included therein. According to the guidance, the scope of information the authority expects to be provided includes, inter alia, the following details:

  • Information about the parties involved, including importers, suppliers, exporters, and manufacturers For these entities, the applicant should provide such details as the name, economic activity, address, and contact details of the responsible persons. 
  • Supply conditions (INCOTERMS) and value of goods to be supplied 
  • Information about the product itself, including details on the materials used, the principal mode of action, and the intended use
  • Details on any recalls or withdrawals the product was subject to at any of the markets where it is present 
  • Details on the specific product being imported, including its brand name, serial number, model, quantity of products, weight, etc. 
  • Details on taxes and tariffs

As further explained by the authority, submissions related to the product should include the following details:

  • Medical device regularisation number;
  • Model of the product, part, or accessory;
  • Commercial presentation of the product, part, or accessory;
  • State of the product;
  • Inclusion of a new item in the registration, if applicable.

Import Purposes

In accordance with the applicable requirements, the purpose for which the product is being imported should also be taken into consideration by the interested party, as it will determine the level of regulatory scrutiny the product will be subject to (together with the other factors, such as the intended use and risks associated with the product). Each of the purposes set forth by the applicable legislation has one or more specific subject codes. In order to assist the parties involved in following the approach prescribed by the respective regulations, the document provides a table outlining the main purposes, namely:

  • Commercial or industrial:
    1. Import by healthcare providers;
    2. Import of a limited number of products for industrial or commercial purposes (different tiers included, for general and in vitro diagnostic medical devices separately);
  • Clinical research (the products are imported solely to be used for clinical research);
  • Use in transport;
  • Return of merchandise (returning goods after being repaired or restored), importation for events and exhibitions;
  • Special Deposit procedure;
  • International donation;
  • Rejection (returning the products rejected abroad);
  • Importation for the Ministry of Health or public entities;
  • Scientific research or technological development;
  • Testing, teaching, or training (covers the importation of unregulated products solely to be used for testing, training, or teaching)

Import Process in Detail

The guidance further describes in detail the importation process and highlights the key points associated with it in terms of the applicable procedures and documents to be submitted by the interested parties. 

Under the general rule, the requirements for importation to be applied with respect to a medical device would depend on the purpose of the product, its type, intended use, and applicable regulations. Moreover, the authority reserves the right to request additional information and documentation, should it be reasonably necessary to assess aspects related to the safety and effectiveness of a medical device. 

Depending on the legal framework under which the device is imported, the scope of documentation the authority would expect to be provided would include a commercial invoice containing the following details:

  • Full name and address of both the exporter and the importer;
  • Specifications for the products in Portuguese or in the official language, accompanied with the translation in Portuguese;
  • Brand, numbering, and, if any, reference number of the volumes;
  • Quantity and type of packages 

The said invoice should be provided in electronic format (searchable). Should the import be outsourced, the invoice should clearly indicate all the companies involved, including the actual purchaser. Pro-forma invoices are not accepted. Commercial invoices in general are not required to indicate the number for traceability; however, for all the items included in the invoice, the applicable batch   or part numbers should be indicated. 

The relevant invoices should be presented for finished goods, accessories to medical devices, and device parts at all product stages, both regulated and exempted from regulation by the authority. 

In summary, the present guidance provides an overview of the regulatory procedures associated with the importation of medical devices. The document outlines the applicable regulatory requirements based on the purpose of importation and also describes the scope of documentation and information to be submitted by an interested party with respect to the product in question and other parties involved.

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