News Details

The National Institute for the Surveillance of Medicines and Foods (Invima) has announced that conventional and daily use toothbrushes are no longer considered medical devices and, as such, do not require sanitary registration for their commercialization and use in Colombia. This decision follows the concept issued by the Specialized Medical Devices and In Vitro Diagnostic Reagents Chamber of the Review Commission, which clarified the sanitary classification of various types of toothbrushes on the market.

According to Act No. 13, manual and electric toothbrushes, commonly used for cleaning teeth, gums, and tongue to prevent cavities and gum diseases, do not qualify as medical devices. Therefore, they are exempt from sanitary registration requirements for commercialization, manufacturing, or importation.

However, the ruling differentiates ultrasonic or radiofrequency toothbrushes, which are intended for professional use only and can be abrasive to dental enamel and soft tissue. These products, due to their specific function, are classified as medical devices and must meet sanitary registration requirements, along with additional manufacturing and importation criteria.

Invima's decision aims to clarify regulations for manufacturers, importers, and consumers while enhancing public health protection.