In this content we will bring all the main steps to register correlates in Brazil. correlates products when entering Brazil need to be regularized so that they can be marketed. Stone Okamont is a regulatory consultancy specializing in regularizing company and product at Anvisa. Anvisa is the Brazilian regulatory agency responsible for regulating products: correlates, medicines, cosmetics and others.
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In order for your correlate product to be within the current legislation, you will need to obtain the following: Operating license, operating Permits, in some cases Certificate of Good Manufacturing Practices and product registration, it is also possible to opt for the Holder Service for company regularization. See below in detail the step by step of all this bureaucratic path.
What are correlates?
Correlates are: instruments, devices, equipment or materials used in dentistry, medicine, aesthetics, beauty and others. Correlates are popularly known as health products, some of the related products are:
•Implantable
• Diagnostic equipment
• Products for in vitro diagnostics
• Medical support equipment
• And others.
How do I know if I need CBPF (Certificate of Good Manufacturing Practices) to register correlates in Brazil?
Before registering correlates in Brazil, it is necessary to have knowledge of their risk classification. The risk classes have a scale from I to IV. I being low risk, II medium risk, III high risk and IV maximum risk. Correlates with risk class I are subject to Notification, risk class II subject to registration and class III and IV subject to registration. Companies with products classified as risk III and IV will need to obtain the Good Manufacturing Practices Certificate to register correlates in Brazil.
What kind of regularization does my company need to register correlates in Brazil?
To register correlates in Brazil, your company can follow the regulation of Anvisa in 3 steps or choose the option of holder Service.
Anvisa regularization steps
Establishment of physical location: The first step of regularizing the company to register correlates in Brazil is to establish a physical location following all the requirements of Visa and Anvisa.
Operating License: This is made with Visa (Local Health Surveillance) of your municipality or state. In this process, the company must adapt its physical structure following the guidelines of the RDC (Resolution of the Collegiate Board) focused on the activity performed by the company in order to receive a Visa inspection agent. In addition, a series of documents and reports related to the establishment are required.
Company Operation Authorization: last regulatory step related to the company to register correlates in Brazil. This process, different from the first, has a federal scope being protocoled in Brasília. The entire technical dossier will be reviewed by Anvisa's technical staff. In order to enter this process, it is necessary to compile all the documentation that makes up the technical dossier, make petitions, collect fees and monitor the entire analysis process to verify that there will be no Anvisa requirements.
What are Anvisa's requirements?
In the processes to register correlates in Brazil there may be requirements. The requirements are: requests for additional documents or data or even requests for clarification about the company or product. Anvisa's requirements can occur at any stage of the regulatory process. But beware! The lack of base documents will lead to the direct rejection of the process to register correlates in Brazil.
Holder services
The Holder services option allows you to take your products to Brazil without the need to establish a physical location. Stone Okamont, through the BRH (Brazilian Registration Holder) hosts its products, requiring only their registration for free commercialization in Brazil.
What does it take to register correlates in Brazil?
After the regularization of the company it is possible to register correlates in Brazil. For this, it is essential to present tests and reports that prove the safety and effectiveness of the product in order to ensure that it will perform its function perfectly without causing any damage to the final consumer. In addition, to register correlates in Brazil, specific information about the type of product will be requested, usually the standard information for all products are: instruction manual, composition, application and others.
Do you need to register correlates in Brazil? Talk to those who understand!
Register correlates in Brazil is not a simple task! To register correlates in Brazil, the experience and expertise of a competent company in regulatory advisory is required. Stone Okamont is the right consultancy for you! Count on Stone Okamont to register correlates in Brazil.
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