On May 12, 2020 Brazil’s ANVISA published new resolution RDC Nº 383  that addresses the direct import of products by health centers.

RESOLUTION – RDC Nº 383 OF MAY 12, 2020

Health establishments are now allowed submit to the surveillance health authority for direct import of products. The resolution defines health establishments as hospitals, ambulatory clinics, medical offices and clinics that perform human health care activities, as well as their foundations, related civil society organizations (OSCIP) and health insurance providers. The import can be done through an Import on Behalf of Third Parties (Contract Importing) and Import Under Order, according to current customs legislation.

content for importation application:

In order to import, it is necessary to register it in the Foreign Trade Integrated System (Siscomex). In addition, it is necessary to submit the following Documents:

  • Electronic import petition (RDC 81/2008).
  • Regularization of the product at Anvisa or authorization, by the director-president of Anvisa, for exceptional import of a product not regularized at Anvisa.
  • Company Operating Authorization (AFE) of the customs terminal for the activity of storing products subject to health surveillance.
  • Special Operating Authorization (AE) for the activity of importing drugs subject to special control.
  • Company Operating Authorization (AFE) providing import services on behalf of third parties.
  • Company Operating Authorization (AFE) for the activity of importing, when importing directly.

Regulatory Summary:

The documents submitted in electronic form must be digitally signed by the legal responsible or legal representative of the importing company, with the use of certificates issued by certification authorities recognized by ICP/Brazil. Imports of products not regulated at Anvisa for clinical treatment are subject to examination and authorization by the Collegiate Board of Directors of Anvisa.

About Global Regulatory Partners:

Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices and pharmaceutical companies globally. GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and Argentina. GRP helps many life science companies register their products in different countries in compliance with local regulations..  To learn more, please contact us at  info@globalregulatorypartners.com

More Resources:

RDC no 383/2020

Brazil’s Anvisa announces new flow for requesting copies of api and drug information


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