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Anvisa, Registration of health products

Sale of Products for the Treatment of COVID-19 unregistered with ANVISA

The resolution RDC 483/21 extraordinarily and temporarily provides the requirements for the importation of health products and drugs identified as a priority for use in health services, due to the health urgency during the pandemic.

According to the regulation of products and drugs related to the RDC 483/21, they can be imported without registration, filing, or notification with Anvisa.


Health products that do not require registration

According to the RDC 483/21 resolution, the products that temporarily do not require notification, certification, or registration are:

  • Infrared thermometer;
  • Pulse oximeter;
  • Multi-parameter monitor;
  • Ten-liter O2 concentrator and components;
  • Medical gas cylinder;
  • Infusion pump;
  • Portable ultrasound;
  • Kit for vascular access;
  • Electrical suction pump;
  • Autoclaves;
  • Humidifiers;
  • Syringes;
  • Surgical masks;
  • Safety goggles;

See the full list here.

Importation process without notification, certification, or registration

Processo de importação sem notificação, certificação ou registro

The importation process was facilitated for health products used in the COVID-19 treatment, except for controlled medications.

The products listed above can be imported, as long as they satisfy the resolution criteria and if the importer can ensure the safety, quality, and effectiveness of the product.

According to article 3 of the resolution, the importing companies must:

I – Follow every other demand applicable to the health control of drugs or medical devices and technical regulations applicable thereto;

II – Perform the post-market surveillance and fulfill any post-market applicable regulation.

According to article 5, every drug and health product must be imported with labels and package inserts in the language determined by the foreign authority responsible for the regularization approval. Additionally, the importer must inform the health units about the information of the labels and provide instructions for the proper use of the product in the Portuguese language.

For the importation of drugs and medical devices, in the terms of this Resolution followed by article 6, the following requirements must be observed:

I – Electronic importation application, in the terms of the Resolution of the Collegiate Board of Directors – RDC no 81, of November 5, 2008;

II – The description of the merchandise on the importation permits shall have the lettering “AUTHORIZED ACCORDING THE RDC no XXX, OF 2021;”

III – Batch clearance certificate, including the final product’s and, if any, the diluent’s quality control analytical report, issued by the manufacturer;

IV – Acknowledgment of boarded cargo;

V – Importation permit (LI) registered with SISCOMEX;

VI – The importer’s Operation Authorization (AFE), if necessary;

VII – In case of drugs, a statement of pre-qualification issued by WHO or of regularization valid in the country and whose competent regulatory authority is a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use – ICH;

VIII – In case of medical devices, a statement of pre-qualification issued by WHO or of regularization valid in the country and whose regulatory authority is a member of the International Medical Devices Regulators Forum – IMDRF;

IX – A proof of fulfillment of the good manufacturing practices, or an equivalent document, of the country;

X – A declaration confirming the adoption of surveillance strategies and the fulfillment of the pharmacosurveillance or techno-surveillance directives, according to the model of Attachment II hereof;

XI – A declaration stating the importation of drugs or medical devices that are essential for the treatment of Covid-19, regularized in a foreign health authority and whose distribution is authorized in the respective country, according to Attachment III hereof; and

XII – If dealing with products regularized in the country, a statement of the corporation that owns the product’s regularization with Anvisa, authorizing the importation by third parties, in the terms of the Resolution of the Collegiate Board of Directors – RDC no 81, of 2008.


About the RDC 483/21 resolution

The resolution published in March 19, 2021, is valid for 60 days, and can be renewed for equal periods according to article 17 of the resolution.

Have in mind that even if the products do not require notification, certification, or registration, the company responsible for the importation must follow this procedure before, during, and after the commercialization of the products.

Therefore, we must stress that the companies must be registered with Anvisa, according to the regulations and demands imposed by the regulatory agency.

For more information, see how to register your company.

If you have any questions or want to know more about this and other regulatory subjects, get in touch with us and talk with one of our experts.