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Resolution RDC n. 13, of January 27th, 2004 – Goods intended for exposure, demonstration or distribution at fairs or events

At the last Hospitalar fair that occurred in May 2019 in São Paulo/SP, Anvisa seized several irregular products and closed some stands. One of the reasons was the lack of authorization for products exposure. This fact happened because most of both national and international companies have no knowledge about RDC n. 13, of January 27th, 2004, which deals with goods intended for exposure, demonstration or distribution at fairs or events.

According to RDC 13/2004 all merchandise that belong to the classes of products for health and products for in vitro diagnostics that are not regularized by ANVISA and are intended exclusively for exhibition at fairs or events, require express and favorable manifestation of ANVISA’s competent sanitary authority to enter the national territory, prior to their customs clearance.

Other obligations are approached in RDC 13/2004 regarding products that are not properly regularized by ANVISA and that will be destined for exposure, demonstration or distribution at fairs and/or events.

If your company intends to import/export health products that are not regularized for the purpose of exposure, demonstration or distribution, and do not know how to proceed, please contact us. Passarini will be delighted to assist you with this and other topics.

Talk to us. Passarini Regulatory Affairs can help you.

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

Passarini Regulatory Affairs

Published: 11/04/2019

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