Do you know what is needed to sell pacemakers in Brazil? Today in this content we will talk about: how to sell pacemakers in Brazil, what pacemakers are, what they are for and what are the requirements for registering them with Anvisa (National Health Surveillance Agency).
Pacemaker is a small device surgically placed next to or near the heart in order to correct cardiac irregularities, such as: Low heart rate and high heart rate. The equipment can be fixed or provisional, the fixed is used for long-term illnesses, while the provisional is used for occasional illnesses, such as arrhythmia due to the overuse of some medication.
To sell pacemakers in Brazil, there are two options to be followed: 1st to establish a physical company in Brazil - regularize company and products. 2nd Use of Holder services: Your company can bring your products through Stone Okamont, which already has the necessary authorizations, being only required to register the product with Anvisa to sell pacemakers in Brazil.
To establish a physical company there are some steps that must be followed:
First step: Choice of location.
Second step: Obtain your operating license. This is done with with VISA - Sanitary Vigilance of the municipality where your company was established. At this stage, it is necessary to adapt the company's physical structure in order to receive Visa's inspection, once the inspection was carried out without any non-conformity, the Operating License will be issued. However, in view of a non-conformities, it will be necessary to comply with VISA requirements within the established period to receive a new inspection.
Third step: it consists of reaching your Operating Permits. Unlike the previous process, this is done directly by Anvisa - National Health Surveillance Agency, so the petition is protocoled in Brasília, where the whole process will take place.
In this phase, a compilation is made with all the necessary documents and collection of fees.
Before selling pacemakers in Brazil, you must submit your product for registration with Anvisa.
Anvisa, as well as the FDA and other regulatory agencies, separate products into risk classes. The risk classfication at Anvisa range from 1 to 4. 1 being the lowest and 4 the highest.
Anvisa classifies the pacemaker as a correlate risk classification 4. In this case, the company must obtain the Certificate of Good Manufacturing Practices in order to be able to sell pacemaker in Brazil, it is a set of rules and procedures that involve all processes related to the product in question. The obligation to obtain CBPF applies to companies with products starting from risk classification 3.
After the regularization of the company, it is finally possible to do the product registration for pacemaker with Anvisa to be able to sell pacemaker in Brazil. In this final stage, information regarding the product is presented, such as: composition material, necessary care, product life, possible side effects, preparation and handling, among others.
Selling pacemakers in Brazil, as well as other products, can be very profitable, but many companies end up giving up, because the company and product regularization processes are very complicated and bureaucratic. Without the necessary knowledge in the area it is practically impossible to complete them without having to redo it several times, thus dispersing a lot of time and money. For this, Stone Okamont has specialists in regulatory affairs to assist you in all stages so that you can sell pacemakers in Brazil quickly and at a lower cost.
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