The stethoscope is a non-invasive instrument, therefore classified by Anvisa (National Health Surveillance Agency) as risk class I - low risk. It is a correlate product - (health product).
Anvisa is the Brazilian agency responsible for regulating products: correlates, medicines, food, cosmetics and others. Every product of these segments when entering Brazil needs to be regularized before its sale.
Knowing the risk classification is the first step to register stethoscope in Brazil, as from this information it is possible to start the regulatory steps necessary to obtain it in an orderly manner. In this content we will briefly discuss each regulatory step to register a stethoscope in Brazil.
Not! To register a stethoscope in Brazil, it is not necessary to obtain the Good Manufacturing Practices Certificate, as the product has a low risk rating. CBPF is mandatory for companies that work with products classified as class III or class IV. Learn more: Certificate of Good Manufacturing Practices.
To register a stethoscope in Brazil there are two options for regularization. The first option is to regularize the company, this process is done in stages, see below:
Initial Stage: Establishment of a physical location following all the rules established by VISA and Anvisa. Without an established physical location, it is not possible to start the company regulatization process.
The Operating License is requested with VISA (Local Health Surveillance) - (municipal or state). this consists of adapting the physical location for a subsequent visit by an inspection agent, who will search for non-conformities following the guidelines of the RDC (Resolution of the Collegiate Board of Directors) according to the activity performed by the company. After the inspection, if there are no requirements by VISA, it will be possible to start the next step. Learn More: Operating License.
To enter the Operation Permits (AFE) process, the document issued by VISa must be attached together with the compilation of the technical dossier to be protocoled. This process is carried out in Brasília and is analyzed by ANVISA, in addition to the documentation, fees, petitions and other items determined by the Health Agency are also collected. Learn more: Operation Permits.
At the end of steps 1, 2 and 3 regarding the regularization of the company, it is finally possible to register a stethoscope in Brazil. For product registration, it is essential to present specific information about it, such as: Composition material, instructions for use, cleaning method, and others. In addition, safety and effectiveness tests are required to ensure that the product safely performs the purpose for what it was produced. Learn more: Product registration.
In addition to assisting in all company and product regularization processes, Stone Okamont has Holder services. With this service, we already have the license and authorization with Anvisa, through BRB (Brazilian Registration Holder) host your product without the need to establish a physical location in Brazil. This saves time and money, in addition to provide greater freedom of choice in relation to how many distributors your company wants to maintain. Learn more: Holder services.
Count on Stone Okamont to assist in all procedures for registering a stethoscope in Brazil. We have a team prepared with trained professionals willing to put our Zero Bureaucracy method into practice. To register a stethoscope in Brazil, regularize a company or any other regulatory process, we at Stone Okamont make our consultancy and advisory available.
Don't waste any more time! Fill out the form below, please contact one of our professionals and get all your questions about how to register stethoscope in Brazil.
Editor: Gabriela Batman Carvalho