Anvisa provides clarification on importing components for medical devices

Check out the Agency’s guidelines on the new flows and frameworks.

Anvisa revises rules on operating authorization for warehousers and importers of medical components.

Anvisa has updated the guidelines regarding the need for an Operating Authorization (Autorização de Funcionamento—AFE) for warehousers in special warehouses and importers of medical device components. These changes apply to finished products subject to agency regularization, based on the new Collegiate Board Resolutions (Resoluções da Diretoria Colegiada—RDCs) 860/2024 and 939/2024.

Here are the main clarifications on the new flows and regulatory frameworks.

Import of medical device components

Since December 4, 2024, Anvisa has defined the following criteria for the obligation to obtain an AFE when importing components:

• Importers of medical device parts

According to article 3 of RDC 16/2014, they are exempt from AFE to import, either for the manufacture of national devices or for the replacement and repair of medical equipment.

• Importers of accessories integrated into regularized medical devices

According to Article 3 of RDC 16/2014, when the accessory is registered with medical or in vitro diagnostic equipment (IVD), no AFE is required for import, regardless of use.

1. Importers of accessories with their regularization

Accessories with individual registration under RDC 751/2022 or RDC 830/2023 require an AFE for import, as they are considered finished medical devices.

Import rules

The import of medical device components follows the rules below, with the need for approval by Anvisa:

• For domestic manufacture
• Purpose of import: Industrial.
• Manufacturing stage: Raw material/input.

SNVS regularization number must correspond to the finished equipment or accessory, provided it is linked to a Brazilian plant or manufacturer.

Third-party importers must present the Declaration of the Holder of the Registration (Declaração do Detentor da Regularização—DDR) authorizing the import.

For replacement or repair of medical equipment

Purpose of import: Commercial, special deposit, return from a repair or event abroad, or exclusive use by a health unit.

Manufacturing stage: Component or accessory of a finished product.

SNVS regularization number must correspond to the regularized finished equipment or accessories, which may include domestic or foreign manufacturers.

Exceptions to the DDR:

1. The DDR is waived if regularization has been canceled for reasons unrelated to health irregularities.
2. The DDR is waived if the equipment’s useful life has expired and the holder’s authorization has not been granted.

Regarding bonded warehouses operating under the Special Deposit customs regime for the storage of medical device components, it should be noted that:

1. Under the terms of RDC 939/2024, Special Deposits are exempt from the Operating Authorization requirement to store products in bonded premises.
2. The other bonded warehouses, which store components, regularized accessories, and medical devices, must fully comply with RDC 939/2024 regarding the obligation to have an AFE for medical devices.

Imports rejected based on previous understandings must be filed again with an attachment of the notice published by Anvisa for immediate analysis. After approval, the importer can request that the item be removed from the initial process.

The new understandings will be formalized in the Import Manuals available on the Anvisa portal.