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Simplified Import Process for Medical Products

By January 19, 2018 No Comments

The National Health Surveillance Agency (ANVISA) recently issued Resolution RDC nº 208, which simplifies procedures for importing food, medicines and hospital equipment. From now on, the procedures are more likely to become simpler and more transparent, facilitating trade.

Some documents that were required before could only be obtained in Brazil, obliging companies to store their products domestically, thus increasing the final prices of products.

Import and export consent procedures are now centralized in SISCOMEX, which allows greater efficiency and homogeneity in the application of sanitary surveillance legislation.

 In addition, as far as labeling is concerned, there has been an extension of the previous legislation, which allows the importers to proceed with the labeling of their products with specific information. For example, requirements for imported foods and medicines have been differentiated. That is, the importer has more targeted information on how to proceed. The documents and steps necessary for the approval of the Import Licensing regarding clinical research have also been defined in more detail, distinguishing product categories.

With this new resolution, ANVISA will no longer require authentication and signature recognition in the documents to be submitted for approval of the required Import Licensing, and simplified the rules regarding products benefited by customs procedures. The regulations have been updated in relation to the use of temporary admission. Products intended for exhibitions, fairs, congresses, or similar events; health and in vitro products intended for educational, scientific or cultural purposes; products for sports purposes, for example.

Such changes will benefit importers and companies, resulting in the reduction of costs in their activities.

For more information on this matter, please access:

http://portal.anvisa.gov.br/documents/10181/2957335/RDC_208_2018_.pdf/eccf9152-9aae-43d0-83b4-e2f6b3015425

 

 

 

Brazil
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