The new article addresses aspects related to the importation of used products, radioactive elements, and products containing animal tissue.

Brazilian Health Regulatory Agency: ANVISA

The Brazilian regulating authority in the sphere of healthcare products (ANVISA) has published revised guidance on the importation of medical devices. The document provides an overview of the applicable regulatory requirements, as well as additional clarifications and recommendations to be taken into consideration by medical device manufacturers, importers, and other parties involved in operations with medical devices. At the same time, it is important to mention that the provisions of the guidance are non-binding in their legal nature, and are not intended to introduce new rules or impose new obligations. The authority also reserves the right to make changes thereto, should such changes be reasonably necessary to reflect corresponding changes to the underlying legislation. 

The document describes in detail the regulatory requirements to be followed depending on the type of medical device in question and also highlights the key points associated with them.

Used Products

In accordance with the applicable legislation, importation of used products is only allowed when the entity intended to import them is the registration holder and also the manufacturer, and the products are imported for repair to reconditioning. At the same time, the importation of used products for any other purpose is strictly prohibited.

Radioactive Sources

Special rules also apply to the importation of radioactive sources. According to the guidance, they could be subject to regulation as accessories to medical devices, or as finished standalone products with separate registration. The information to be provided with respect to the products to be imported should include, inter alia, the following details:

  • Source specifications (e.g., radionuclide, quantity, and form);
  • Purpose of use;
  • Radionuclide activity (measurement value and date);
  • Source destination (name and address of the institution where it is going to be installed) 

The above information should be included in a declaration to be submitted by the importer.

Changes to the Registration

The document also outlines the types of changes to the existing registration of a medical device based on the impact of such changes and other important factors. These types include: 

  • Approval change required: this type applies to changes that are associated with a significant potential impact on the safety of patients and could be introduced only after (i) they have been authorized in the jurisdiction where the device in question is coming from and (ii) the appropriate technical documentation has been provided to and reviewed by the Brazilian authority. 
  • Changes of immediate implementation: the ones that could be introduced under the notification or registration process, provided the expected impact of such changes is medium. 
  • Non-reportable changes are all other changes that have lesser safety impact and, consequently, do not require prior approval in order to be implemented. 

 In the case of imported medical devices, the rules outlined above should apply as follows:

  • For non-reportable changes, no registration will be required; medical devices could be imported immediately after the changes have been implemented. 
  • For immediate implementation changes, the appropriate protocol will be required. 
  • For changes of approval required, the appropriate prior approval of the authority will be required.

Tissue-containing Products

The applicable legislation also provides special rules to be applied in the case of medical devices containing tissues or fluids of animal origin. Irrespective of the importation purpose, a set of documents should be provided to the authority with respect to such products, including details on product identification and expiration dates. The authority additionally emphasizes the importance of ensuring the respective application form is completed with correct and accurate information, as this would impact the classification of a product based on the geographic risk and the respective degree of infectivity. The external packaging of such products should be clearly visible and accessible during the inspection. Failure by an interested party to provide all the information required will result in the application for importation permission being rejected. 

As it was mentioned before, the country of origin would be one of the most important criteria. The applicable regulation distinguishes countries with negligible, controlled, and unknown risks, and the level of regulatory scrutiny would greatly depend on this determination. 

Depending on the applicable requirements to be determined as described herein, an interested party would have to provide:

  • A certificate of conformity for the raw materials;
  • A certificate of good manufacturing practices referring to the original manufacturer;
  • An international veterinary certificate (the authority acknowledges that the specific form would depend on the country and applicable national requirements, however, it should anyway contain details on the raw materials used, batch number, and place of manufacturing);
  • An analytical report of quality control of the finished product issued by the manufacturer based on the quality control analysis the product in question is subject to The said document should contain such details as the name of the product, batch, expiration date, manufacturing date, and name of the manufacturer, as well as the results of the appropriate analysis conducted.

In summary, the present ANVISA guidance provides a brief overview of the regulatory requirements to be applied with respect to specific categories of healthcare products intended to be imported into the country. The document describes the approach to be followed when determining the applicable regulatory framework and also outlines the scope of the documents to be provided.

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