Hi,
I'm looking for your opinion about the classification rule to be applied in this case:
The product is actually a cosmetic device, it is a film-forming sticky paste used for local treatment of cracks (no wounds) on the heels and feet. Due to its formulation, the product has unique pain reducing and create a thin protective layer on the affected area. The product works by filling the crack on feet or hands and using a small amount of water to activate and create the protective barrier. A strong and tight seal over and around the protected area is formed, thus ensuring maximal product efficacy.
Our Health authority said that this product should be a medical device. So when I look to the classification rules: I have 2 options:
Rule 21: the product will be classified as class IIa as it is substance based devices
OR
Rule14: our product includes a very low percentage (<1%) of Zinc oxide which is considered as medicinal product and this rule covers devices incorporating, as an integral part, a substance considered, if used separately, to be a medicinal product, and that has an action ancillary to that of the devices. SO if I will consider this rule, the device will be a class III. Knowing that the zinc oxide cannot have an ancillary action because in literature it is well demonstrated that Zinc oxide in paste should be present at 16, 20 and 40 %.
Can someone guide me to proceed.
I'm looking for your opinion about the classification rule to be applied in this case:
The product is actually a cosmetic device, it is a film-forming sticky paste used for local treatment of cracks (no wounds) on the heels and feet. Due to its formulation, the product has unique pain reducing and create a thin protective layer on the affected area. The product works by filling the crack on feet or hands and using a small amount of water to activate and create the protective barrier. A strong and tight seal over and around the protected area is formed, thus ensuring maximal product efficacy.
Our Health authority said that this product should be a medical device. So when I look to the classification rules: I have 2 options:
Rule 21: the product will be classified as class IIa as it is substance based devices
OR
Rule14: our product includes a very low percentage (<1%) of Zinc oxide which is considered as medicinal product and this rule covers devices incorporating, as an integral part, a substance considered, if used separately, to be a medicinal product, and that has an action ancillary to that of the devices. SO if I will consider this rule, the device will be a class III. Knowing that the zinc oxide cannot have an ancillary action because in literature it is well demonstrated that Zinc oxide in paste should be present at 16, 20 and 40 %.
Can someone guide me to proceed.