The nasogastric tube is a polyvinyl chloride tube used in patients suffering from swallowing problems or who cannot feed orally. Usually, this type of probe is common for short meals, a period of 4 weeks at most.
The application of the probe is done by the nose descending to the esophagus towards the stomach and to confirm that the tube is in the correct place doctors do confirmation tests, such as air insufflation, auscultation and even x-ray.
This product is categorized as correlated by ANVISA and before it is registered it will be necessary to obtain the following: Operating license, operating authorization, in some cases Certificate of Good Manufacturing Practices.
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For the registration of the nasogastric tube to occur it is essential to present tests and reports that prove the safety and efficacy of the product in order to ensure that it will perform perfectly its function without causing any harm to the final consumer.
Operating License
This is the first stage of regularization of the company to register nasogastric probes in Anvisa, this is done with Visa (Local Sanitary Surveillance) of your municipality or state.
In this process it is up to the company to adapt its physical structure following the guidelines of the RDC (Resolution of the Collegiate Board) focused on the activity carried out by the company in order to receive a supervisory agent from Visa. In addition, a number of documents and reports related to the establishment are required.
Company Operating Authorization
The last stage of regularization: Company Operating Authorization (AFE) is analyzed directly by Anvisa. In this process, documents collection, collection of fees, and others takes place.
After the approval of EPHA, it will be possible to perform the registration of the negatoscope for dentistry.
How to register nasogastric tube?
All companies offering products that may be harmful to health, such as medicines, pesticides, cosmetics and etc; need to be up to date with all regularizations with ANVISA.
After the company's regularization it is possible to register the nasogastric probes in Anvisa. For this it is essential to present tests and reports that prove the safety and efficacy of the product, in addition to specific information about the product, such as: accessories, instruction manual, composition material and others.
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Stone Okamont has 100% approval in all departing from ANVISA. Contact one of our collaborators and learn how to register nasogastric tube.
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