How to register support wires in ANVISA?

How to register support wires in ANVISA?

Support wires are health products used as an aesthetic purpose to combat premature aging and expression wrinkles.  The product is composed of filaments with small cones that through a fixation process remains between the skin and the skin tissue.

This type of product has become a great ally in the correction of sagging, besides stimulating collagen production in the applied areas, that is, the support wires also slow aging.

ANVISA classifies the support wires in the category of correrelated with the risk classification III.

Prior to the marketing of this product, you will need to obtain the following documents: Operating License, Operating Authorization, Certificate of Good Manufacturing Practices and Product Registration.

It is necessary to understand that, in order to perform the petitioningof products that are subject to Sanitary Surveillance, those that may offer health risks, it is mandatory to regularize the company responsible for manufacturing and distributing such products.

If you find it difficult to adapt your company or product under current laws seek advice.

Stone Okamont specializes in company and product regularization at ANVISA. Click on the link below and request your quote!

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See what steps are required to obtain the registration of support wires in ANVISA.

 Step 1: Operating License

Before you file an application for the registration of support wires in ANVISA, the first step is to obtain the Operating License for your establishment. It is acquired from a survey conducted by VISA, the Local Sanitary Surveillance.

Stone Okamont works with excellence in the preparation of the Operating License process with VISA.

The Operating License is an approval document with the local Sanitary Surveillance, recognizing that your establishment has technical and operational conditions to carry out your activity and take you to the next step that is the Company Operating Authorization.

Step 2: Company Operating Authorization

The Company Operating Authorization, better known as "AFE", is a document issued by ANVISA, published in the Official Gazette of the Union (DOU), it enables you to carry out its activity which was petitioned with the Agency. Obtaining “AFE” means that the company operates in accordance with Brazilian legislation and is able to operate nationwide.

The "AFE" is necessary and indispensable for the next step that is the petitioning of the CBPF, that is, Certificate of Good Manufacturing Practices.

Step 3: Good Manufacturing Practices

The Certificate of Good Manufacturing Practices (CBPF), is the document that attests compliance with the guidelines of the legislation in force for the manufacture of a given product. It is issued to prove that the company has been instructed and inspected during the manufacturing process.

To register the support wires in ANVISA, an its classification is risk class III, the Certificate of Good Practices is a requirement of ANVISA, which has one of the most improved parameters in the world, attesting that the establishment complies with good manufacturing practices.

The risk classification products III and IV must need the Certificate of Good Practices with ANVISA.

Step 4: Record of support wires

The Product Registration is the document issued by ANVISA legalized commercialization of the same. From that moment on, the Agency will review the petition in the most appropriate way, verifying the documentation submitted to certify that the company is in accordance with current legislation and able to develop its activities.

In this final step, product information such as: composition material, instructions for use, disposal instructions, and more are presented. In this way, the petitioning process must be respected, and mandatory documentation must be attached and the petition must be filed with ANVISA.

Companies that offer products that may be harmful to health, such as medicines, pesticides, cosmetics, etc.; they need to be up to date with all regularizations with ANVISA.

Come to Stone Okamont!

We operate exclusively, adjusting and elaborating all the necessary procedures for the implementation of the quality system according to the needs of each client.

We have specialized professionals in all areas, allowing you to be appointed an expert with adequate knowledge for your field of activity, so that this process flows in an agile way and avoiding rework.

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