How to regularize Kinesio tape at ANVISA?
In this blog we are going to talk about a health product that you have probably already seen in professional athletes, but you had no idea that there was a reason for its use, the Kinesium tape.
What you will see in this blog:
- What is Kinesium tape;
- Necessary regularization for this type of product;
- Do I need a Certificate of Good Practices to register Kinesium tape;
- Clear your doubts.
What is Kinesium Tape?
This is a colorful elastic bandage method developed decades ago, which has recently gained notoriety due to its wide use by athletes.
Kinesio tape has several functions, including supporting muscles, joints, tendons and ligaments, in addition to promoting stability and range of motion, enhancing the results of the treatment with which it is applied to people's skin.
What kind of regularization does my company need to register related items with Anvisa?
To regularize related matters, your company will need to obtain:
Operating/Health License: Granted by VISA (Local Sanitary Surveillance) of your municipality or state. In this process, it is up to the company to adapt its physical structure, following the guidelines of the RDC (Resolution of the Collegiate Board) focused on the activity that will be carried out by the company, in order to receive a supervisory agent. In addition, a series of documents and reports related to the establishment is required.
Operating Authorization: Last step. This process, unlike the first, has a federal scope. being filed with ANVISA. At this stage, we must file the report issued by VISA with ANVISA, for evaluation by the technical staff, in addition to collecting fees and monitoring the entire analysis process to verify that there are no requirements from ANVISA.
Once these steps are completed, you will be able to proceed with the regularization of the Kinesium tape at ANVISA.
Do I need the Good Manufacturing Practices Certificate to register Kinesium tape with ANVISA?
Before regularizing the Kinesium Tape at ANVISA, it is necessary to know its risk classification.
The risk classes have a scale from I to IV. I being low risk, II medium risk, III high risk and IV maximum risk. Correlates with risk class I are subject to Notification, risk class II subject to registration and class III and IV subject to registration. Kinesium Tape is classified as risk I and must only be notified, which is a slightly simpler process than registration, therefore to regularize Kinesium tape it is not necessary to obtain CBPF - Certificate of Good Manufacturing Practices, a document required for classes III and IV.
All right! You can now regularize Kinesio tape at ANVISA
Although Kinesium tape is only notified, ANVISA imposes a series of requirements so that the product does not cause any type of damage to the final consumer, such as presenting instructions for use, product images, models, among other information.
Even products subject to registration or notification only have extensive and bureaucratic processes, with a series of requirements imposed by ANVISA. If you are looking to regularize your company and/or your product, contact Stone Okamont. We have excellent qualified professionals ready to assist and advise you in all this bureaucracy.
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