According to the explanation of comprehensive consulting professionals, the real medical mask is a product that can repair and care for skin wounds, scars or postoperative injuries such as laser surgery, and is applied to the skin surface (including the face). This kind of products basically belong to the second or third category of medical devices. Those who need to obtain a registration certificate need to do clinical experiments to verify the efficacy and safety.
So how do you apply? Referring to the procedure of medical device registration, first of all, the product should pass the registration form test; Secondly, the factory should establish a system according to the corresponding medical device production quality management norms; Third, the production conditions and personnel of the factory meet the requirements of registered products; Fourth, clinical and clinical experimental reports are needed to prove that the product is safe and has corresponding curative effect. No clinical products can provide effective documents to prove that the products are safe and effective; Fifth, submit a full set of technical documents to apply for registration with the drug supervision department. After the registration, you can get the registration certificate. With the product registration certificate, you have to apply for a production license from the factory.
With the product registration certificate and factory production license, you can mark the registration number on the product, and you can legally publicize the medical mask and the corresponding repair and nursing effect.
This declaration process is much more complicated than expected, and it is more worry-free to find a professional agency.