Product to be Used with Needle Rollers: Cosmetic or Medical Device?

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Navigating the regulatory classification of products used with needle rollers is highly nuanced. Many factors need to be considered to determine whether products designed for use with dermal rollers fall under cosmetic regulations, medical device regulations, or even regulated as medicinal products. Furthermore, a different regulatory framework may apply to the dermal roller itself. This White Paper explores the complexities of classification and the determination of the correct regulatory status of products used with dermal rollers, as well as what manufacturers need to consider to ensure compliance.

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Iryna Berchak
RA Consultant
Iryna Berchak

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