ANVISA Brazil requirements for medical device labels
Chapter 6 of RDC 751/2022 outlines medical device labeling requirements. The regulation went into effect in 2023; however, labeling requirements mostly remained consistent with the previous regulation.
Medical devices must carry a label that conveys information necessary for the safe use of the medical device. Whenever possible, the label must appear on the medical device itself or on the label of its individual packaging. Otherwise, it must appear on the label of its commercial packaging. If it is not possible to individually package each unit, this information must be included in the instructions for use that accompanies the device.
Like other markets, the term “labeling” in Brazil refers to information accompanying a medical device, including the device label itself and Instructions for Use (IFU), even when supplied in electronic form (i.e., e-Labeling).
The information on labels and instructions for use must be written in Portuguese.
The device label must contain the following information:
- Company name and address of the legal manufacturer, preceded by the term "manufacturer" or equivalent symbols
- Company name and address of the holder of the notification or registration
- Commercial name of the product, indicating the model, when applicable
- Serial number or other identifier that allows equipment traceability
- "Sterile" and the sterilization method, if applicable
- Batch code, preceded by the word "Lot", or the serial number, as applicable
- Date of manufacture and expiration date or date before which the medical device must be used
- Indication that the medical device is for single use, if applicable
- Specific conditions for storage, conservation and handling of the product
- Special instructions for operation and:or use of the medical device
- All warnings and precautions to be adopted
- Name of the technically responsible person legally qualified for the role
- Notification or registration number of the medical device
Instructions for Use (IFU) requirements for medical devices in Brazil
All medical devices must include IFU in their packaging or reference how to access these documents if delivered electronically or via the internet. IFU provides information about how to operate the device, under what conditions, as well as other essential safety information, such as:
- Device’s intended use and indications for use
- Any possible undesirable side effects or contraindications
- Information about avoiding certain risks associated with the device
- How to properly install or connect the device for use with other devices
- How to properly maintain and calibrate the device for safe use
- Instructions for sterilization methods, if applicable
- Descriptions of appropriate procedures for reuse and the number of reuses, if applicable
- Information about drugs administered by the device, if applicable
Class I and II devices may be exempt from providing IFU in the packaging if there is sufficient evidence that safe use of these products is guaranteed without IFU.
ANVISA Brazil requirements for medical device e-Labeling
IFU may be provided on physical media, via the Internet, or in another electronic format as long as it meets all ANVISA requirements. However, e-labeling must adhere to additional requirements to ensure accessibility, including:
- Provide instructions for how to obtain electronic IFU on the device’s external label.
- Provide access to a printed version of the IFU at no cost to the user and instructions on how to obtain it.
- Ensure availability of electronic IFU for as long as the device is in use.
- Specify the resources necessary for the user to read the IFU.
If you are providing IFU via the internet, there are additional accessibility, version control, and security requirements you must follow.
