Controlling blood pressure is important for both hypertensive patients and those who suffer from very low blood pressure. In this content we will discuss the necessary regulations with Anvisa to sell blood pressure meters in Brazil.
To sell blood pressure meter in Brazil it is necessary to go through some regulatory steps with Anvisa - National Health Surveillance Agency.
To sell blood pressure meter in Brazil, there are two options to be followed: 1st to establish a physical company in Brazil – to 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 blood pressure meter in Brazil.
Steps to establish a physical company in Brazil:
1st: Choice of location.
2nd operating license. For this, the company must seek the adequacy of your company according to the current legislation, according to your area of activity. Having done this, it must request the establishment's inspection from the Local Health Surveillance - VISA. After a conclusive opinion by the agent responsible for the inspection, your document will be issued and it will be possible to proceed to the next step. Click: Operating License.
3rd Operation Permits. A physical compilation must be made from forms, documents and fee collection. This will be protocoled in Brasília and will be analyzed by the National Health Surveillance Agency - Anvisa. The process takes around 60 to 120 days. Click> Operation Permits.
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.
blood pressure meter fits into a correlate risk class 2, thus, it is not mandatory to obtain the Certificate of Good Manufacturing Practices in order to be able to sell blood pressure meter in Brazil. CBPF is a certificate required by Anvisa for products with a risk class between 3 and 4.
Good Manufacturing Practices is the part of Quality Assurance that ensures that products are consistently produced and controlled, with quality standards appropriate for the intended use and required by registration. Recalling that the manufacturer is responsible for the quality of the products manufactured by him, ensuring that they are suitable for the purposes for which they are intended, comply with the requirements established in his registration and do not put consumers at risk for presenting inadequate safety, quality or effectiveness. Do you want to know more? Click: Certificate of Good Manufacturing Practice.
After the regularization of the company, it is finally possible to register the product in order to be able to sell blood pressure meters in Brazil. For this, it will be necessary to gather a series of information, such as: Label, instructions for use, measurement information, effectiveness tests and others Click> Product Registration.
Before selling a blood pressure meter in Brazil, the company and the product need to be regularized by the responsible agency. This is an arduous task, as it involves a lot of bureaucracy and knowledge in the current legislation.
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Editor: Gabriela Batman Carvalho