The nasal dilator is known for providing better breathing in conditions of nocturnal nasal congestion and also congestion that is caused by allergy and flu.
To register a nasal dilator at ANVISA, we need to go through the company's regularization steps, which consist of obtaining the Operating License and Operating Authorization. After completing these steps, it will be possible to start the product registration process.
We know that regulatory procedures are bureaucratic and complicated, so we created this article to help you.
See what are the necessary steps to get a nasal dilator regularized at ANVISA.
This content will be divided into 4 parts: Operating License, Operating Authorization, Risk Classification and Product Registration. In this way the reading can be directed to your current doubt.
Before submitting the application for regularization of a nasal dilator at ANVISA, the first step is to obtain the Operating License for your establishment.
The Operating License issued by the Health Surveillance Agency (VISA) authorizes the operation of your company's activities, after verifying compliance with all the rules established by the RDC corresponding to the activity carried out. This is the most criterious phase of the entire process.
In this process, it is up to the institution to adapt its physical structure to receive the inspection of a VISA’s inspection agent, who will evaluate the place's technical and operational conditions so that your establishment can function and it takes you to the next step, which is the Company Operation Authorization.
The Operating License is necessary and indispensable for the next step, which is the petition of the Company Operating Authorization.
The Company Operation Authorization (AFE) is one of the most important regulatory steps for the success of your business, and for this reason, it is necessary to have specialized technical support.
The Company Operating Authorization, better known as “AFE”, is an ANVISA’s permission for the company to carry out its activities. The document that will be published in the Official Gazette (DOU) must be requested to start activities such as: manufacturing, distributing, storing, transporting, importing and exporting.
In this phase, petitions, verification of documents, payment of fees, among others, take place. Each category requires specific documentation and it is very important to pay attention to the base documents, as the lack of these can result in an instant rejection.
Obtaining the AFE indicates that the company operates in accordance with brazilian legislation and is able to operate throughout the national territory.
For each type of regularization, there is a different process to be carried out at ANVISA. Notification or registration are product regularization modalities. Each type of regularization modality has a different process time.
Nasal dilators are classified as Risk Grade 1 and 2. Risk class 1 are simpler and are notified, while registered class II dilators have specific indications that require proof of safety and efficacy, information on care, method and usage restrictions.
In the case, if it is an internal nasal dilator, they are normally classified as risk class II, you will probably need a little more documentation, especially in terms of efficacy and safety to ensure that this product is safe and that it can be used by any ordinary consumer.
The Product Registration is the document issued by ANVISA legalizing its commercialization. After petitioning the process, the agency will analyze the documentation presented to make sure that the product complies with current legislation and is ready to be commercialized.
In this final step, information is presented, such as composition, qualitative and quantitative analysis of the product, instructions for use, disposal instructions, among others. In other words, a well-prepared dossier is essential for the approval of the product registration at ANVISA.
Our regulatory affairs department is responsible for the regularization of products and establishments. Our role is to guide and provide technical support in order to establish the ideal regulatory strategy for the company's success and competitive advantage.
Talk to those who understand! Count on Stone Okamont to regularize nasal dilators at ANVISA. We have a team of trained professionals ready to meet the needs of your company and product.
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