Packaging, Labeling & Marking
Requirements
The Brazilian Customer Protection Code requires that product labeling provides the consumer with precise and easily readable information about the product’s quality and quantity, composition, shelf life, origin, and risks to the consumer’s health and safety. All imported products must bear labels containing this information in Portuguese and indicate the brand or name of the manufacturer. Labels should include metric units or a metric equivalent.
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In addition, ANVISA and INMETRO have their own set of rules concerning product labeling and marking. Labeling rules and IFUs provide important information about the product, such as its contents, indications, warmings, and storage conditions.
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Most cases of imported products that suffer market restrictions by ANVISA, such as recall, withdrawal, suspension of sales and use etc. are due to labeling discrepancies, mislabeling, or irregular labeling. Therefore, ensuring compliance with labeling requirements is of upmost importance.
ANVISA Regulations on Packaging and Labeling
As per Resolution RDC 751/2022, medical devices must include on their labels several important information in Portuguese, such as:
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​In addition, all medical devices must include Instructions for Use (IFU) in their packaging. The IFU may not be included, exceptionally, in the packaging of class I and II products, as long as the safe use of these products can be secured without such instructions.
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If a medical device is reusable, it is required to display information on appropriate reuse procedures, including cleaning, disinfection, packaging and the sterilization method, when applicable, and any restrictions on number of reuses.
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Resolution RDC 156/2006 establishes additional labeling provisions regarding the inclusion of statements such as “reprocessing is forbidden” or “single use recommended by the manufacturer”, and the rules for when these sentences must or mustn’t be included.
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Manufacturing and expiration dates;
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When applicable, the indication that the medical device is for single-use only;
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The specific storage, conservation, and handling conditions;
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Notification or registration number;
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Name and address of the legal manufacturer and of the notification or registration holder;
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The necessary information for the user to identify the medical device and the contents;
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When applicable, the word "Estéril" (“Sterile”) and the sterilization method;
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Lot, batch, or serial number, as appropriate;
Traceability Labels
Resolution RDC 556/2021 establishes the addition of traceability labels or tags for implantable medical devices. The manufacturer or importer must provide at least 3 traceability labels to identify each implantable material or component.
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The traceability labels must include at least the following information: product name, identification of the manufacturer or importer, product code, batch number, the ANVISA registration number, and in some cases, the UDI support.
UDI
The provision for the identification of medical devices through the Unique Medical Devices Identification (UDI) system is set by Resolution RDC 591/2021. This system is being adopted by ANVISA for the identification of medical devices in the Country and applies to all devices regulated by Anvisa, except custom-made medical devices and medical devices under clinical investigation.
UDI is a numeric or alphanumeric character string created through worldwide accepted device identification and coding standards, that allows for the unambiguous identification of a specific device on the market. The UDI system is designed to provide a unique identification, globally harmonized, for the identification of medical devices during their distribution and use, which requires labels to carry a unique device identifier linked to a public UDI database. The UDI database is an electronic system that contains information and other identification elements associated with a particular medical device through its UDI number. Examples of UDI supports are: linear barcode, matrix/two-dimensional (2D) barcode, QR code, RFID.
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The manufacturer's quality management system shall implement control mechanisms to ensure the correct assignment of the UDI to all devices manufactured by it or on its behalf; hence, it is the manufacturer’s responsibility to assign the UDI to the product. The notification or registration holder is responsible for submitting and transferring the data to the UDI database and for ensuring the consistency and validity of this information.
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Before placing a device on the market, the manufacturer shall assign to the device and, where applicable, to all upper packaging levels, an UDI created in compliance with the rules of the issuing entity designated by Anvisa. The UDI supports shall be placed on the label or on the device itself, and on all upper packaging levels.
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Resolution RDC 591/2021 came into force in January 2022 and was amended by RDC 884/2024 in June 2024. The deadline for manufacturers to attribute and affix UDI to their medical devices are escalated based on the risk class and calculated from the effective date of RDC 591/2021, as follows:
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Compliance with the provisions of Resolution RDC 591/2021 is optional for the medical devices manufactured prior to the deadline; and will be mandatory afterwards.
Compliance Confirmation
We will ensure that packaging, labeling and markings are in accordance with the specifications established by Anvisa, INMETRO, and the Brazilian laws.
Avoid Penalties
To avoid any unforeseen penalties, we will elaborate the labeling and IFUs according to the Brazilian standards and translate the contents to Portuguese.
Maximize Your Product's Potential
We will evaluate the feasibility of reusing the device in Brazil and guarantee that classification during the registration process is executed accurately.
Stay Updated
We shall inform you regarding any changes in the legislation and upcoming deadlines in a timely manner, thereby ensuring that you have sufficient time to prepare adequately.
Strategies for Reusable Medical Devices
Devices that can be reprocessed are welcome in Brazil and have high demand. Our knowledge of the Brazilian medical device market and our experience in registering reusable products give us the advantage of identifying and recognizing these devices, registering them in the right manner, and distributing them widely.
Best Market Opportunities
We can identify the best market opportunities and registration strategies for single-use and reuse medical devices.
Reuse and Reprocessing Techniques
We can assist you in the preparation of booklets and technical materials about reuse and reprocessing practices.
Compliance with UDI requirements
We will help your company through the steps to correctly assign unique codes to your devices and ensure compliance with UDI requirements.
...and much more!
Get in touch
Send us a message, we will be glad to help you through the pathway into the Brazilian market.
+55 (51) 3937-8726