Anvisa changes import subject code for medical devices intended for repair or servicing

The subject code “90370 – Import Authorization for Medical Products Used for Repair or Servicing by Legal Entities” has been deactivated. Importation for this purpose should now be done using the subject code for commercial or industrial purposes. Only manufacturers and registered holders in Brazil will be authorized to make this type of importation.

Imported products that have already been nationalized and are being temporarily exported for repair or servicing should be imported using the following subject code: “90358 – Import Authorization for Return of Goods after Repair, Servicing, or Restoration, submitted to temporary exportation.” This code can also be used for goods returning to Brazil after temporary exportation for trade shows or events. The necessary documents for this importation include: purchase invoice or declaration of ownership of the goods or products, export declaration or equivalent customs document proving the departure of the goods or products.

For products manufactured within national territory that have been exported and are returning to the country of origin for repair or simply product return, they should be petitioned with the subject code for commercial or industrial purposes. In case of rejection, the following subject code should be used: “90449 – Import Authorization for Return of Health Products Produced in National Territory and Rejected Abroad.” Information regarding import authorization for these purposes can be found in RDC 81/2008.

For more information and explanations about it, send us an e-mail: contato@passarini.com.br

Passarini Group

Published: 15/12/2022