The otoscope is a medical equipment used to examine the ear. With the otoscope it is possible to observe the external and middle auditory canal by visualizing the eardrum. The equipment is divided into 3 parts: handle, head and speculum (usually disposable, it is the component with a conical shape inserted in the ear). There are different types and sizes of specula for otoscope.
The otoscope is a health product, therefore submitted to Anvisa (National Health Surveillance Agency). Anvisa is the Brazilian agency responsible for regulating products: correlates (health products), sanitizers, cosmetics and others.
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To register otoscope in Brazil, your company also needs to be regularized with Anvisa. Stone Okamont offers two regulatory advisory options to register otoscope in Brazil, check it out!
Option 1 - Company regularization
The regularization of the company to register otoscope in Brazil is divided into 3 parts, Establishing a company, Operating License and Operating Permits. See below:
Establishment of a company: consists of having a physical company in Brazil fulfilling all the requirements imposed by VISA and Anvisa.
Operating License: Process evaluated by VISA (Local Health Surveillance), municipal or state. In this process, it is up to the company to adapt its physical structure in accordance with the RDC (Resolution of the Collegiate Board of Directors) related to the activity performed by the company, in addition, a series of documentation related to the location is necessary in order to finally receive an inspection by a Visa inspection agent.
Operating Permits: This is the last company regularization process to register otoscope in Brazil. It takes place in Brasília and the entire process will be verified by Anvisa agents. At that moment, fees are collected, documents are compiled and others.
Option 2 - Holder service
Choosing the Holder Servicer option makes it possible to regularize your products in Brazil without the need to establish a physical location. The products are hosted by Stone Okamont through the Brazilian Registration Holder, thus requiring only their registration.
Do I need CGMP (Certification of Good Manufacturing Practices) to register otoscope in Brazil?
Anvisa classifies the otoscope as correlate with risk rating I - Low risk. Due to the low risk classification, it is not necessary to obtain the Certificate of Good Manufacturing Practices to register otoscope in Brazil. It becomes mandatory for companies that operate with products classified as risk III- High risk and risk IV-Maximum risk.
What does it take to register otoscope in Brazil?
After the regularization of the company, it becomes possible to register otoscope in Brazil. The regularization of the product consists of submitting to Anvisa tests that prove the safety and effectiveness of the product in question, in order to ensure that it performs its function without causing any type of damage to the final consumer. In addition, to register otoscope in Brazil, specific information about the product will be requested, such as: Composition material, form of hygiene, instruction manual and others.
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Register otoscope in Brazil is a bureaucratic process that requires the attention of a consultancy specialized in regulatory intelligence. Stone Okamont is the right consultancy for your business!
Count on us to assist in all regulatory processes for register otoscope with Anvisa.
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