Brazil RDC 751: Classification, Dossier and Labeling
2:09 · English
The resolution took effect in March twenty twenty-three.
What you’ll learn
- The resolution took effect in March twenty twenty-three.
- Prepare the evidence appropriate to the device and route.
- Check the scope before reusing this framework.
Read the video transcript
Working on a device submission for Brazil? RDC seven fifty-one connects three questions: how the device is classified, which authorization route applies and what information supports the product.
The resolution took effect in March twenty twenty-three. It sets requirements for medical-device classification, notification, registration, labeling and instructions for use under ANVISA’s framework.
Begin with the intended purpose and the device’s characteristics. Review the technical description against the actual product before deciding which classification rules apply.
The regulation uses four classes. Classes one and two follow notification; classes three and four require registration. Lower risk does not mean the technical and compliance responsibilities disappear.
Prepare the evidence appropriate to the device and route. The technical documentation should support safety and performance, while applicable manufacturing-quality requirements need to be addressed as well.
Labeling and instructions are part of the regulatory work. Check the required Portuguese information and make sure product identifiers and claims agree with the technical documentation.
Check the scope before reusing this framework. In vitro diagnostics have a separate regulation. Product-specific rules and later requirements may also apply, so RDC seven fifty-one is not the entire checklist.
A useful Brazil plan links classification, evidence and lifecycle maintenance. Our glossary explains RDC seven fifty-one and connects it with ANVISA and the wider Brazil guidance.
Read the full glossary at Pure Global. One partner for medical device registration and regulatory support across more than thirty markets.