The nasoenteral probe is a medical product whose only functions is to auxiliary the dietary procedures of enteral nutrition. It is inserted from the narin to the stomach or the intestine (duodenum or jejunum), requiring X-ray control to check the site of the probe.
Unlike the nasogastric tube, nasoenteral probes may have a thinnest caliber that causes less trauma to the esophagus.
Because of its high resistance, they can remain in the patient for a good period of time, about 5 months or more. Thus, the exchange of the product is only necessary when they present problems such as rupture, obstruction or malfunction.
The nasoenteric probe allows the administration of nutrients through the normal digestive route. It can be used in any age group for solving different problems. Its purpose is the maintenance or correction of nutritional status.
This product is categorized as correlated by ANVISA and to register a nasoenteric probe will be necessary to obtain the Operating License and Operating Authorization.
To register a nasoenteric probe it’s essential to present tests and reports that prove the safety and product efficacy in order to ensure that it will perform perfectly its function without causing any harm to the final consumer.
All companies subjected to sanitary inspection, with products that may offer health risks, such as medicines, pesticides, cosmetics, etc. need to be up to date with all regularizations at ANVISA.
After the company's regularization it is possible to register a nasoenteric probe at ANVISA. For this it is essential to present tests and reports that prove the safety and efficacy of the product, in addition to specific informations about the product, such as: accessories, instruction manual, material composition and others.
This is the first stage of the company regularization to register nasoenteric probe in at ANVISA, this part is made with at the brazilian Local Sanitary Surveillance (VISA) of its municipality or state.
The Operating License is a documentation that grants if the establishment has technical and operational conditions to perform the desired activity.
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.
The Product Registration is the document issued by ANVISA regularizing its commercialization. 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 the current legislation and able to develop its activities.
In this final step, product informations such as: material composition, instructions of use, disposal instructions, and more needs to be presented. In this way, mandatory documentation must be attached and the petition must be filed at ANVISA.
Stone Okamont has 100% approval at ANVISA. Contact one of our collaborators and learn how to register a nasoenteric probe.
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