How to register IUD at ANVISA?
The Intrauterine Device (IUD) is a small T-shaped structure, inserted inside the woman's uterus, this method is used to prevent pregnancy, it can be made up of copper, hormones, among other combinations, having several advantages and disadvantages, despite to be used for the same purpose.
To register an IUD with ANVISA, there are several normative instructions, rules and steps that must be followed with ANVISA. Dealing with bureaucracy is complicated, contact Stone Okamont, we do all the work for you from start to finish. No rework and unnecessary expenses.
See what steps are required to register IUDs with ANVISA.
Topics of this blog
- Operating license;
- Company Operating Permit (AFE);
- Good Manufacturing Practices;
- Intrauterine Device Registration;
- Clear your doubts.
1st step: Operating License
Before registering the IUD with ANVISA, the first step is to obtain the Operating License for your establishment. It is acquired from an inspection carried out by VISA, that is, the Local Sanitary Surveillance.
Stone Okamont acts with excellence in the elaboration of the Operating License process with VISA.
The Operating License is an approval document from the local Sanitary Surveillance, recognizing that your establishment has technical and operational conditions to carry out its activity and take you to the next step, which is the Company Operating Permit.
2nd step: Company Operating Authorization
The Company Operating Authorization, better known as AFE is a document issued by ANVISA, published in the Official Gazette (DOU), which enables you to carry out your activity in which you were petitioned with the Agency. Obtaining the AFE means that the company acts in accordance with Brazilian legislation and is able to operate throughout the national territory, to register Immunoglobulin at ANVISA.
The Company Operating Authorization is necessary and essential for the next step, which is the application for the CBPF, that is, a certificate of Good Manufacturing Practices.
3rd step: Do I need the Good Manufacturing Practices Certificate to register IUDs with ANVISA?
The Certificate of Good Manufacturing Practices (CBPF) is the document that attests to compliance with the guidelines of current legislation for the manufacture of a given product. It is issued to prove that the company was instructed and inspected during the manufacturing process.
Before registering an IUD with ANVISA, it is first necessary to classify it.
ANVISA classifies the IUD as risk class IV, that is, according to current legislation, risk class III and IV products must obligatorily need the Certificate of Good Practices from ANVISA 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.
4th step: IUD registration at ANVISA
Product Registration is the document issued by ANVISA legalizing its sale. From that moment on, in order to register an IUD with ANVISA, the agency will analyze the petition in the most appropriate way, verifying the documentation presented to certify that the company complies with current legislation and is able to carry out its activities.
In this final stage of the IUD registration, product information is presented, such as: composition material, instructions for use, instructions for disposal, among others. In this way, the petition process must be respected, the mandatory documentation must be attached and the petition must be filed with ANVISA.
All companies offering products that may be harmful to health, such as medicines, pesticides, cosmetics, etc.; need to be up to date with all the regularizations with ANVISA.
Steps completed, you can now register IUD with ANVISA!
The bureaucratic processes to regularize a company and obtain the IUD Registration are not easy. For this, Stone Okamont offers you a quality service with excellent professionals who will make bureaucracy a relief in your time, which we know how precious it is.
Contact us! Fill out the form below, talk to one of our professionals and get all your questions answered about how to register an IUD with ANVISA.
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