The import of dental products is a growing market, especially for high-demand materials such as zirconia blocks and lithium disilicate. These products, essential for state-of-the-art dental procedures, require a specific import process that involves strict regulations. In this article, we will explore how to import these products, highlighting the necessary steps, the role of ANVISA, and how Licempre can help your company navigate this process efficiently.
Why Import Zirconia and Lithium Disilicate Blocks?
Zirconia and lithium disilicate blocks are materials widely used in dentistry for making crowns, bridges, and other dental restorations. Demand for these products has grown due to their durability and superior aesthetics, making them popular among dentists and dental laboratories.
Risk Class 2: What Does It Mean?
In Brazil, dental products are classified into different risk classes, according to the potential impact on human health. Zirconia and lithium disilicate blocks are classified as class 2 risk products. This classification means that they present a moderate risk, which simplifies the registration process with ANVISA, making imports less bureaucratic compared to higher-risk products.
Import Process: Step by Step
- Register with ANVISA– The first step to importing dental products is registration with ANVISA. For Class 2 risk products, such as zirconia and lithium disilicate blocks, the process is relatively simpler. ANVISA requires a series of documents, including proof of compliance with safety and effectiveness standards.
- AFE for Import –The Business Operating Authorization (AFE) is essential for any company that wants to import dental products. The AFE is issued by ANVISA and guarantees that the company is legally qualified to import and sell health products in Brazil.
- Required Documentation – For the import process, it is crucial to have all documentation in order. This includes the import license, certificates of conformity, as well as manufacturer-specific documents that prove the quality of the products. Relying on Licempre’s expertise can facilitate the organization and submission of this documentation, reducing the risk of delays and complications.
- Logistics and Customs Clearance –The import of dental products involves well-coordinated logistics, from transportation to customs clearance. The importing company must have an efficient logistics plan to ensure that products reach their final destination without delays. Furthermore, customs clearance must be done accurately to avoid fines or retentions..
Licempre is a company specialized in regulatory consultancy, with extensive experience in dental products. With a team of qualified professionals, Licempre offers complete support, from registering with ANVISA to obtaining the AFE and monitoring the logistics process. Counting on Licempre means ensuring the entire import process is carried out quickly, safely, and within current regulations.
Importing dental products such as zirconia blocks and lithium disilicate can be an excellent business opportunity, but requires attention to regulatory and logistical details. With the right support, like that offered by Licempre, your company can access these high-demand materials with peace of mind, ensuring quality and compliance at every stage of the process.
If you are considering importing dental products, the key to success is good preparation and strict compliance with legal requirements. Licempre is ready to help your company obtain the necessary licenses, ensure compliance with ANVISA, and optimize logistics operations. Contact us to learn how we can help your company grow in the dental products market.