The Brazilian Health Regulatory Agency, ANVISA, issued Resolution RDC 751, which recently specified the standards and guidelines for the notification, registration, post-approval modifications, and revalidation of medical devices in Brazil. ANVISA’s Resolution of the Board of Directors (RBD) No. 751/2022 was recently published and has been effective from March 01, 2023.
According to the new standards, information on labels and Instructions for Use (IFU) must meet the following requirements
- The information on the labels and IFUs must be written in Portuguese.
- All medical devices must include IFUs within the package or mention the method of accessing the documents.
- IFUs can be excluded for medical devices falling under classes I and II in scenarios where the safety of their use can be ensured without such instructions.
- All necessary information for safe medical device use should be printed on the medical device, individual package labels, or commercial packaging. If placing each unit individually is not possible, the information can be included in the IFU that comes with one or more medical devices.
- Symbols and colors that comply with the regulations can be used; however, if there are no specific regulations, the significance of these symbols and colors must be described.
- If additional information is required in a technical regulation due to product specificity, it could be included in the label or IFUs.
The label template must contain the following information
- The legal manufacturer’s company name and address, preceded by the term ‘manufacturer’ or its equivalent symbology.
- The notification or registration holder’s corporate name and address.
- The information required to identify the medical device and its packaging by the user.
- Mention the word ‘sterile’ and the method of sterilization when applicable.
- The lot code, followed by the word ‘lot,’ or the serial number, depending on the case.
- Date of manufacture and expiration, or the last date before which the medical device must be used.
- Product handling and storage instructions.
- Special medical device operating instructions.
- Precautions and warnings.
- The name of the technical person who is responsible legally and is qualified for the function.
- The notification or registration number for medical devices, preceded by the ANVISA identification symbol.
The IFUs must cover the following information
- IFUs must include all the points included in the label template checklist. Exclude the lot number, manufacturing and expiration dates, and notification or registration number.
- Include the manufacturer’s intended use and any potential negative side effects.
- If a medical device is to be installed or connected to another medical device for the former device to function properly, detailed information about its characteristics must be provided. This is required to identify the medical device that can be used with the said product to ensure a safe combination of the two devices.
- Mention all information about installation, workability, and frequency of maintenance.
- List the risks associated with medical device implantation and the risks of reciprocal interference arising during usage.
- Include all necessary sterilization steps and re-sterilization methods in the event of a tampered package. Mention the methods and amount of reuse in the case of reusable devices. Include information on additional steps to be performed before using the device.
- If a medical device emits radiation, describe the nature, type, intensity, and distribution of the radiation.
- Include the contraindications and precautions related to radiation emission, magnetic fields, environmental factors, electrical influences, electrostatic discharges, pressure variations, and thermal ignition.
- Include adequate information on the drug contained in the medical device and restrictions for the use of the same.
- Include information on performance accuracy for medical measuring devices.
Equipment subject to health surveillance or registrants must bear an indelible label indicating the following
- The commercial name of the product, with an indication of the model, when applicable.
- The name of the legal manufacturer or brand.
- The notification or registration number with ANVISA.
- The serial number or other identifiers that allow for the traceability of the equipment.
- Where the implantable equipment is so small that it cannot be labelled, include registration, identifying the manufacturer or brand, and traceability elements.
- For systems, all their components must be identified as members of the system with which they are associated.
- Non-implantable, single-use equipment is exempt from the provisions of the cap.
IFU in the unprinted format must cover the following information
- Provide a method of identification for the version of the IFU that corresponds to the respective product.
- Provide customer service details where a printed format of the IFU can be requested at no additional cost (including shipping).
- Make sure that the IFU is available for the duration of the market availability of the device.
- Specify the resources required by the user to read the IFU. When the dimensions of the external labeling do not permit the inclusion of the resources, the information in the article may be included in a document attached to the product.
- Alert users to observe the version of the manufacturer’s IFU indicated with the purchased product.
In addition to the information listed above, IFUs available on the Internet must include the following
- Provide clear instructions on how to find the correct version and usage of the product at the electronic address available on the Internet.
- The IFU file available in the email address should be in a non-editable reading format. Guarantee the basic security requirements of the email address.
- Provide free access to the tool (at the email address) required to read the user instructions.
- Ensure that the file made available is identical to that provided in the printed format by the manufacturer.
It is prohibited to make the following IFUs only available in the unprinted form
- Equipment for health use that indicates:
- Domestic use in general, including those intended for use in home-care services.
- Operation by lay people, regardless of the place of use.
- Health materials used by lay people.
RBD No. 751/2022 is an important step towards more effective medical device regulation, making the Regulatory process safer and more streamlined.
ANVISA will accept medical device registration petitions with the technical report beginning in March 2023 if filed by February 28, 2023.