Defibrillator is a device that discharge moderate electrical charges in the heart with the intention of restoring heart rate. The equipment used in cardiopulmonary arrests works through plates positioned on the chest.
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There are 3 types of defibrillators:
- Vital Functions Maintenance Unit: Equipment used to monitor vital functions such as: blood pressure, heart rate, temperature, oxygenation and others. This equipment is used only by health professionals allowing the use of the defibrillator function when necessary to revive or correct arrhythmias.
- Automatic External Defibrillator: DEA is a small device that can be handled even by laypeople through prior training. The equipment has “artificial intelligence”, automatically measuring the heart rate and the voltage required for correction based on the data captured in the patient.
- Implantable Defibrillator Cardioverter: ICD is a small device implanted under the skin together with a pacemaker. The device identifies arrhythmias and acts with electrical impulses to correct them.
Anvisa (National Health Surveillance Agency) classifies defibrillators as correlate (health products) with a variable in the risk classification from III - high risk to IV - Maximum risk. Class IV - Maximum risk, is the classification for invasive products such as the case of the CDI equipment.
Both risk classifications are subject to the Certificate of Good Manufacturing Practices to register defibrillators in Brazil. Obtaining this certificate is mandatory for any company that operates with products classified as risk class III and IV.
Anvisa is the Brazilian agency responsible for regulating products: correlates, medicines, sanitizing products, cosmetics and others. Every product within these segments must be regularized before being sold.
The first step to register defibrillator in Brazil is to be aware of its risk rating! See in this content all the steps necessary to register defibrillator in Brazil.
What is needed to register defibrillator in Brazil?
In order to register defibrillator in Brazil, it is essential to prove the effectiveness and safety of the equipment through reports and tests. Once this is done, you will also be asked to provide specific information about the product, such as: voltage, accessories, instruction manual, composition material and others.
Before registering products, the company must be properly regularized with Anvisa, otherwise it will not be possible to register defibrillator in Brazil.
Below are two regularization options for registering defibrillator in Brazil.
Option 1: Company Regularization
The first stage of regularization to register defibrillator in Brazil is to establish a physical location in Brazil following all the conditions imposed by VISA and Anvisa.
Second stage: Operating License> This is requested from VISA (Local Health Surveillance) - (Municipal or state). In this regulatory stage, the company must adapt its location following the guidelines of the RDC (Resolution of the Collegiate Board of Directors) related to the activity performed for subsequent inspection by a Visa inspection agent.
Last stage of regularization: Operating Permits (AFE)> It takes place in Brasília and is analyzed directly by Anvisa. In this process, documents are compiled, fees are collected and others.
Option 2: Holder services
We also offer Holder Service where there is no need to establish a physical location in Brazil. Choosing this option, Stone Okamont through BRB (Brazilian Registration Holder) hosts its products, requiring only their registration, minimizing time and costs.
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