Oximeter is a small device that has the function of measuring oxygen saturation in the blood, that is, evaluating the amount of oxygen in the arterial blood. This equipment is an important ally for the detection of respiratory problems.
Types of oximeters
- Finger oximeter: more suitable and common (small portable clamp)
- Wrist oximeter: most used in patients with sleep apnea (similar to a wristwatch, it has a cable that leads to the finger)
- Handheld oximeter (small palm-sized screen)
- Pediatric or neonatal oximeter (adapted portable clamp)
- Fetal oximeter (used during childbirth)
- Table oximeter: has more measurement items besides saturation (is only one non-portable, used in doctor's offices, clinics and hospitals)
- Brain oximeter. (has sensors to assess oxygen levels in the brain and vital organs)
The aforementioned oximeters have a risk rating variation of 2 for non-continuous use portable and 3 for monitoring use.
The non-continuous use oximeter is classified by Anvisa (Health Surveillance Agency) as correlate with risk classification 2 - Medium risk. In this way, it is not necessary to obtain the Certificate of Good Manufacturing Practices, it is mandatory for companies with products that have a risk rating from 3, as is the case with some types of oximeters.
Anvisa is the agency responsible for regulating products related to the health, sanitation and other areas, all products in these segments must be regularized before their sale.
Do you know what it takes to sell oximeters in Brazil? In this content we will talk about each process to sell oximeter in Brazil.
What does it take to sell oximeter in Brazil?
To sell oximeter in Brazil there are two options: regularization of company and product or adhere to Holder services.
Option 1: Company regularization
The regularization of the company is instituted in three parts.
1- Establish physical location in Brazil
2- Operating License - VISA - (Local Health Surveillance). To obtain it, the company must adapt its physical structure to receive a Visa inspection agent. He will inspect the place following the guidelines of the RDC - (Resolution of the Collegiate Board) related to the activity performed by the company.
3- Company Operation Permits (AFE) - Anvisa - (National Health Surveillance Agency). This regulatory step takes place in Brasília and must be done in a physical and digital way. Occurs in this process, collecting fees, compilation of documents and others.
How to register oximeter at Anvisa
Company regularization completed! The last step to sell oximeter in Brazil is to regularize the product. In order to regularize any product, it is essential to present reports and tests that will prove the safety and effectiveness of the product, in addition, specific information about the product is requested, such as: Instruction manual, composition material, time for checking results, measurement of results and others. Learn more: Product registration.
Option 2: Holding Services
With Holder Service, there is no need to set up a physical company in Brazil. Stone Okamont, which already has a license and authorization, hosts your product, requiring only registration. This way you will have the freedom to choose how many distributors you want to keep to sell oximeters in Brazil.
Contact Stone Okamont
We can assist you in all processes to sell oximeters in Brazil. Stone Okamont has a technical team with professionals trained in several areas and updated in current legislation. Count on us to help you sell oximeter in Brazil.
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