ANVISA Brazil Medical Device & IVD Classification & Grouping
Brazil medical device classification determines regulatory requirements for your device.
Brazil medical device classification rules
ANVISA, Brazil’s medical device regulator, dictates regulatory requirements for medical devices and IVDs based on their risk classification. Like most markets, Brazil medical device classification is determined by a range of factors and product characteristics, like the product's intended purpose, invasiveness, and duration of use. ANVISA imposes pre- and post-market regulatory requirements as the risk level increases to ensure the safety and efficacy of the product.
RDC 751/2022 (link in Portuguese) is the regulation that applies to medical devices in Brazil. It includes 22 classification rules that range from non-invasive products to special rules for more complex categories of medical devices:
- Non-Invasive Products: Rules 1 to 4
- Invasive Products: Rules 5 to 8
- Active Products: Rules 9 to 13
- Special Rules: Rules 14 to 22
Medical devices are classified into four tiers of increasing risk:
- Class I - low risk
- Class II - medium risk
- Class III - high risk
- Class IV - maximum risk
If your device was approved before the implementation of RDC 751/2022 in March 2023, you will need to verify that your device classification is the same under the expanded classification rules. If there is uncertainty about how to classify a medical device based on the rules outlined in the resolution, ANVISA will determine the classification.
ANVISA device registration validity timelines
Authorizations for Risk Class I and II devices do not expire unless they are revoked for reasons such as reevaluation, inability to address non-compliances, or fraud detection. On the other hand, approvals for Risk Class III and IV products are granted for ten years following their publication in the Brazilian Official Gazette and must be renewed to continue legal distribution of the device.
Brazil IVD classification rules
RDC 830/2023 is the regulation that applies to all IVD medical devices in Brazil. It went into force in June 2024 and introduced substantial changes to the classification of IVDs from the existing regulation. Similar to medical devices, IVDs are classified into four tiers of increasing risk based on 11 classification rules in the regulation:
- Class I: Low risk to the individual and low risk to public health
- Class II: Medium risk for the individual and: or low risk for public health
- Class III: High risk for the individual and: or medium risk for public health
- Class IV: High risk to the individual and high risk to public health
If your IVD was approved before RDC 830/2023 came into effect, you may need to confirm your device’s classification under the new regulation. Many IVDs have been up-classed under the new rules, particularly Class II IVDs moving to Class III.
Frequently
Asked Questions
How do I know if my device classification changed under new Brazil device regulations?
ANVISA will not contact you if your device or IVD classification has changed. You must perform a classification assessment to confirm your classification under RDC 751 or RDC 830. The new classification rules are almost identical to the classification rules in the EU Medical Devices Regulation (EU MDR 2017/745) and EU In Vitro Diagnostic Devices Regulation (EU IVDR 2017/746). If you already have CE Marking under the MDR or IVDR, your classification is likely to be the same under Brazil’s new regulations.
How does medical device family grouping affect my registration requirements and costs in Brazil?
Grouping allows you to compile a single notification or registration application for multiple products with the same characteristics (e.g., its intended use, indications for use, legal manufacturer, etc.). However, grouping criteria vary by device type. Accessories can sometimes require their own approval, as well. Separate registrations will incur additional fees and, depending on the classification of a separate device or accessory registration, additional regulatory requirements.
Do I need a Brazil Registration Holder for Notification of a Class I or II device?
Yes. You must designate a BRH if you don’t have a legal entity in Brazil, even for the notification process. Your BRH will keep a copy of your technical file, labeling, and Instructions for Use (IFU) on file, as well as liaise with ANVISA as needed for post-market compliance, such as event reporting, recalls, etc.
How does Brazil device classification affect QMS requirements?
Class I and II devices are exempt from Brazil Good Manufacturing Practice (BGMP), ANVISA’s quality management system requirements. Manufacturers of class III and IV devices must obtain BGMP certification by passing an audit by ANVISA. In general, the certificate is submitted with your registration application, though it’s possible to apply for ANVISA registration before your BGMP audit is complete. If your ANVISA registration is approved, it is conditional on your BGMP audit.
