In Brazil, ANVISA (Brazilian National Health Surveillance Agency) registration certificates are usually designed for the sale of medical devices, medicines, cosmetics, etc., on the market, and not for clinical trials. There are different regulations for clinical trial devices.
For clinical trial devices, you may be required to obtain approval or permission from ANVISA, but this may be based on a specific clinical trial application. In Brazil, anvisa oversees the registration and regulation of medicines, medical devices and other health products. Clinical trials involve human trials and often require special approvals and regulations.
Before conducting a clinical trial, you will need to submit an application to Anvisa, which includes the trial plan, study protocol, investigational drug information, etc. These documents need to meet Anvisa's regulations and go through the relevant approval process. anvisa evaluates the compliance and ethics of clinical trials to ensure that the trials are safe and scientific.
Therefore, for clinical trial devices, you may want to contact Anvisa to understand the regulations and procedures that apply to your specific situation. At the same time, it is recommended that you seek professional legal and regulatory advice to ensure that your clinical trial meets the regulatory requirements in Brazil.