Understand how the updates to RDCs 860/2024 and 939/2024 impact the import and storage of medical device components and accessories in Brazil
Anvisa has updated the processes and flows related to the import and storage of medical device components. With the recent publication of Collegiate Board Resolutions (RDCs) 860/2024 and 939/2024, importers need to understand the new requirements and how QR Group can help them comply with these regulations. In this article, we discuss the changes and how to ensure that your company complies with the standards efficiently and safely.
Impacts of the New RDCs on the Importation of Medical Device Components
With the entry into force of RDCs 860/2024 and 939/2024, Anvisa established new requirements for the import of medical device components and accessories. These updates directly affect import flows and the authorizations required for products to be regularized.
QR Group, as a specialist in health regulations, offers technical support so that international and national companies can quickly adapt to these changes, minimizing risks and ensuring compliance with ANVISA.
Operating Authorization: Requirements for Importers
As of December 4, 2024, Anvisa implemented the following guidelines on the mandatory Operating Authorization (AFE) for importing medical device components:
- AFE Exemption: Importers of medical device parts or accessories do not need an AFE, regardless of the purpose (manufacturing national medical devices or replacing parts in medical equipment in use), as long as the component does not have its own regularization.
- Mandatory AFE: For importers of accessories that have their own regularization, such as those regulated by RDC 751/2022 or RDC 830/2023, it will be necessary to obtain an AFE for import.
Requirements for Importing Components for Domestic Manufacturing
The import of components intended for the domestic manufacturing of medical devices follows detailed requirements that must be strictly observed. The information required in the LI/LPCO model includes the industrial purpose, the manufacturing stage, and the regularization number of the finished product, among others. QR Group can provide guidance on each step of this process, ensuring that your import is in compliance with ANVISA.
Storage and Special Deposits: What You Need to Know
Customs warehouses that operate under the Special Deposit regime do not need AFE to store medical device components, as stipulated by RDC 939/2024. However, warehouses that operate with finished medical devices or accessories with their own regularization must comply with the established standards to ensure compliance. QR Group provides guidance on best practices for storage and regularization processes with ANVISA.
How QR Group Ensures Fast and Efficient Compliance
With extensive experience in healthcare product regulation, QR Group offers expert advice to importers and manufacturers of medical devices. Our team is prepared to guide your company through ANVISA’s complex requirements, ensuring that all import and storage flows are carried out accurately and efficiently.
If your company needs to comply with ANVISA’s new requirements for importing and storing medical device components, contact QR Group. Our expert team can help you comply with all regulations and accelerate your compliance process safely and efficiently.
Source: ANVISA
