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 …
Difference between Registration and Notification of Health Products at Anvisa: Understand the Processes and Rules
Regulating medical materials and equipment is essential in the health sector to guarantee product safety and efficacy. In Brazil, Anvisa establishes the requirements necessary for these products to be authorized for sale, classifying them according to the risks they pose to the …
The integration of the payment of the health surveillance fee into the Single Foreign Trade Portal is scheduled. Check the implementation schedule.
Anvisa is promoting the integration of the payment of the Health Surveillance Inspection Fee (TFVS) and the import process protocol (LI/LPCO) into the Centralized Payment for Foreign Trade (PCCE) module, available on the Single Foreign Trade Portal (Siscomex ) This initiative …
Anvisa updates form for Business Operation Authorization and Special Authorization
Since last Thursday, October 3rd, the forms used to request the Business Operating Authorization (AFE) and Special Authorization (AE) in the Solicita system will undergo an update. This change will affect requests for the granting of authorizations provided for in Collegiate Board …
E-Notivisa will now register notifications of adverse events and technical problems related to food
The new system module will be launched during a webinar on 9/23, at 10 am. Join in! Next Monday, September 23, at 10 am, Anvisa will hold an online seminar (webinar) to present the new e-Notivisa module. From now on, the …
How to Import Dental Products
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 …
Inmetro Starts Second Phase of Proficiency Testing in Physical Chemistry for Calibration of Gas Meters
Registration will be open from August 12 to August 30, 2024. The Brazilian Institute of Metrology, Quality and Technology (Inmetro), through the Directorate of Scientific, Industrial and Technology Metrology (Dimci), is promoting the second Round of the Proficiency Test in Physical Chemistry …
Anvisa clarifies that phosphoethanolamine is not approved for cancer treatment.
The substance is not permitted or registered as a food supplement or medicine in Brazil. Anvisa informs the population that phosphoethanolamine is not authorized or registered as a food supplement or medicine in Brazil. The commercialization of this substance can only …
The Importance of Product Registration Hosting Service for the Success of Your Business
Product registration hosting service is an essential process for businesses that import, manufacture, and distribute products. This service involves managing and storing documents and information necessary for the official registration of products with regulatory authorities. Hosting these records ensures that all required …
Licempre’s Expertise in Automotive Component Certification
The certification of automotive components is an essential process to ensure the safety, quality, and compliance of products that reach the market. In Brazil, this certification is carried out by Product Certification Bodies (PCB), which are responsible for validating whether products …