Market Authorization:
Registering a Medical Device
Device Grouping
Anvisa grants registration of individual products as well as of families, systems, and set/kits, based on the grouping of products, much like other major global markets. Differences in size, dimension, or shape, for example, generally do not matter.
If you have multiple products that are similar, it is pivotal to determine the correct product family grouping, because this will determine the number of petitions (submissions) required to Anvisa. Grouping is crucial for regulatory strategy as it determines how devices can be authorized in a regulatory petition and can significantly reduce costs overall.
The definition of family in RDC 751/2022 describes that products within a family must have similar technical characteristics in five areas: ​​​​​​​​​
Indication and intended purposes
Operation and mechanism of action
Embedded
technology
Contents or composition
Precautions, warnings, and special cautions
​Grouping is determined according to the following regulations, depending on the medical device category. ​​​​​​​​​
In the case of materials, the initial step is to determine if the device is listed on the specific regulation (IN 101/2023). If not, grouping should be evaluated according to the general rules set by RDC 556/2021.
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Accessories in medical equipment require a separate registration only if one of the following conditions apply: the manufacturer is different; it is not an active accessory and is subject to authorization by Anvisa as a material, IVD, sanitizer, cosmetic, medical device etc; or it is a nonactive accessory with a higher risk class than the medical equipment itself.
Device Grouping
We will determine proper device grouping to simplify regulatory processes, using a wholesome approach – we also take into consideration the impacts that proper grouping will play on taxation, customs, importation, marketing etc.
Grouping Evaluation
We can evaluate and customize product grouping to reduce the overall costs.
...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