How to register the Oximeter at Anvisa?August 03, 2020
The registration of products at Anvisa is established so that the products can be marketed in Brazil.
To register the Oximeter with Anvisa, the manufacturer must first hold the AFE – Authorization for the operation of the company (Anvisa) and all the requirements established by the regulatory bodies in due course. After that the product registration process is done.
What is the Oximeter?
The oximeter is a medical device used by health professionals to measure and monitor the amount of blood transported in the human body.
It is a small medical equipment that is placed on the patient’s fingertip, in a non-invasive way, where through a light it is able to measure the pulse rate and when there is oxygen in the vascular system making the assessment of the quantity.
In assessments where oxygenation has very low levels, it disrupts the body’s natural functioning, overloading the heart and brain, so this equipment is very important and it is used by many health professionals.
How is the registration process of the Oximeter at Anvisa?
Now you know that the oximeter is very important, but before being used by health professionals and marketed, the oximeter needs to be registered with Anvisa.
To register an oximeter with Anvisa, the manufacturer must pay attention to all requirements, and the first step is to collect all the technical information of the product, both for manufacture and for import.
Information such as product characteristics, instructions for use, composition, classification among others, are mandatory when registering the oximeter with Anvisa.
After safety and efficacy tests are done at INMETRO, registration is made at Anivsa.
Recalling that the company must have the LF (Operating License) and AFE (Operating Authorization). If you do not have these authorizations, you must first regularize the company with Visa and Anvisa.
Why have an advice when registering the Oximeter with Anvisa?
Now that you know how the oximeter registration process with Anvisa is done, you can count on Licempre to assist your company in all regulatory processes.
Through our advice you have more agility and less bureaucracy. Get in touch and talk to our experts.[/vc_column_text][/vc_column][/vc_row]