How to register products for micropigmentation?

How to register products for micropigmentation?

ANVISA classifies as cosmetic every product that has the purpose of beautify. Before registering cosmetics with ANVISA, the company needs to regulate its situation.

Micropigmentation is the implantation of pigment in the skin. This treatment is more recommended for those who have flaws in the region of the eyes, mouth or eyebrow because it is possible to draw the contour of the face, illuminate and correct flaws.

The process is very similar with the definitive makeup and because of this the application of the pigment should be done with great caution to give an air of naturalness to the appearance.

There are two types of micropigmentation: aesthetics and paramedical. Aesthetic micropigmentation is the implantation of pigment in the skin motivated by aesthetic reasons, since paramedical micropigmentation occurs by a medical indication to correct flaws in the region of the eyebrows, eyes or around the mouth, such as burns, sagging, among other problems.

What are the aesthetic products for micropigmentation that require registration with ANVISA?

In micropigmentation is used a device called dermograph, whichapplies the pigment with needles manufactured for this purpose. Product registration is required for dermographs, needles, pigments, and other materials used in the procedures.

Who can be autuado?

Manufacturers, distributors, retailers, micropigmenters or any natural or legal person who manufacture, market or even perform the procedures without proper registration.

To register products for micropigmentation ANVISA will be necessary initially to obtain the company's regularization, this consists of the Operating License and Operating Authorization. After these steps are complete, you can begin the product registration process.

This content will be divided into 3 parts: Operating License, Operating Authorization and Product Registration. In this way the reading can be directed to the current need of the reader.

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See what are the necessary steps to obtain the registration of micropigmentation products 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.

The Operating License is the first document issued by the Health Surveillance (VISA), legalizing the operation of the activities of your company and respecting all the standards established by the DRC corresponding to the activity performed. It's the most judicious phase of the whole process.

In this process it is up to the institution to adaptits physical structure to receivethe inspection of a visa supervisory agent to evaluate the technical and operational conditions of the site, so that its establishment can function and take you to the next step that is the Authorization of Company Operation.

The Operating License is necessary and indispensable for the next step that is the petition of the Company Operating Authorization.

Step 2: Company Operating Authorization

The Company Operating Authorization (AFE) is one of the most important regulatory steps for the success of your business, and for this reason, it is necessary to count on specialized technical support.

The Company Operating Authorization, better known as "AFE", is a permission of ANVISA for the company to carry out its activities. The document, which will be published in the Official Gazette (DOU), must be requested to start activities such as: manufacture, distribute, store, transport, import or export.

In this phase there are petitions, verification of documents, collection of fees among others. Each type of category requires specific documentation, it is very important to look at the basic documents, because the lack of these can result in instant rejection.

Obtaining The AFE means that the company operates in accordance with Brazilian legislation and is able to operate throughout the country.

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.

Does it look complicated? Talk to those who understand registration in ANVISA!

If you are looking to register micropigmentation products with ANVISA and are encountering many difficulties, please contact Stone Okamont, our company has excellent professionals willing to perform all the intermediation between you and the regulatory agency in question.

With personalized service, Stone Okamont ensures the success of your registration. We use our expertise to deliver results satisfactorily, with reduced spending and Zero Bureaucracy.

Fill out the form below, talk to one of our professionals and ask all your questions. 

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