It is understood that many so-called medical masks are actually registered as medical cold compress patches and then promoted as medical masks. In fact, as long as the drug regulatory department investigates, this is absolutely illegal. The medical device itself There are strict requirements for functional claims.

According to the explanation of comprehensive consultation professionals, a real medical mask is one that has repair and care effects on skin wounds, scars or postoperative injuries such as laser surgery. It is applied on the skin surface (including the face). Products like these posted. Such products are basically Class II or Class III medical devices. A registration certificate is required, and some require clinical trials to verify efficacy and safety.

So how to apply? Just refer to the medical device registration procedure. First, the product must be able to pass the registration form test; secondly, the factory must establish a system according to the corresponding medical device production quality management specifications; thirdly, the factory’s production conditions, personnel, etc. must meet the requirements of the registered product. Corresponding requirements; fourth, clinical trials are required, and clinical test reports prove that the product is safe and has corresponding efficacy. For clinical-free products, effective documentation can be provided to prove that the product is safe and effective; fifth, a complete set of qualified technical documents must be submitted to the drug regulatory department to apply for registration. Once the registration is completed, you can obtain the registration certificate. With the product registration certificate, the factory must apply for a production license.

With the product registration certificate and factory production license, the registration certificate number can be marked on the product, and the medical mask can be promoted legally and compliantly, as well as the corresponding repair and care effects.

This type of application process is much more complicated than imagined, so it is easier to find a professional agency