Cosmetic and Medical Tattoos, National and International Regulatory Requirements on Instruments and Commercial Ink Stock Products.

This chapter explains the international regulative framework on equipment and inks for cosmetic and medical tattooing. In the following text, the word "tattooing" refers to body tattooing, permanent makeup, and microblading. From a global perspective, regulation of equipment for cosmetic (decorative) tattooing, and especially inks, is inconsistent and mainly based on a diversity of national laws. In contrast, regulation of equipment for medical tattooing is subjected to the internationally harmonized medical devices regulation. Even though dermal invasiveness and biological mode of action are identical for cosmetic and medical tattooing, the regulatory requirements are separated in two divergent regulative frameworks.