The laryngoscope is an equipment composed of two parts: handle and blade. The equipment has the function of providing a full view of the larynx and vocal cords to the health professional. The equipment can be used both for the examination of laryngoscopy and for the intubation of patients. In addition, the equipment can be used for simple observation examination of the larynx and pharynx. The laryngoscope has several types of blades, each type with its specific functionality. The most common blades are flat and curved. The equipment is sterilizable and autoclavable, usually made of stainless steel and has a light source.
Anvisa (National Health Surveillance Agency) classifies the laryngoscope as a correlate with risk class II - Medium risk. The equipment parts can also be sold separately, both: cable and blades are also correlate with risk class II- Medium risk. Due to the low risk classification, it is not necessary to obtain the Certificate of Good Manufacturing Practices (CGMP) to register a laryngoscope in Brazil. CGMP is mandatory for companies that operate with products with risk classification III - High Risk and IV - Maximum risk. Learn more: Certificate of Good Manufacturing Practices.
Anvisa is the Brazilian agency responsible for regulating products such as: medicines, cosmetics, correlates, sanitizing and others.
In this content we will go superficially into all the regulatory steps necessary to register a laryngoscope in Brazil, do you have any doubts? Check below all the steps to register a laryngoscope in Brazil.
Before registering a laryngoscope in Brazil, it is essential that the company is properly regularized, there are two options to achieve it, check it out:
Establishment of a physical location: The first step in registering a laryngoscope in Brazil is to establish a physical location in Brazil respecting all the requirements of VISA (Local Health Surveillance) and Anvisa.
Operating License: The second step in regularizing a company to register a laryngoscope in Brazil is to obtain an Operating License. This license is requested from the municipal or state VISA, in this process a series of requirements are required in relation to the physical establishment, in addition it is up to the company to adapt its location following the guidelines of the RDC (Collegiate Board Resolution) related to the activity practiced, in order to receive inspection from a Visa inspection agent. Learn more: Operating License.
Operating Permits: This step, different from the previous one, has a federal scope and takes place in Brasília, the entire technical dossier will be analyzed directly by Anvisa agents. Compilation of documents, petitions and collection of fees are some of the actions taken at this stage of the process. Learn more: Operating Permits.
Choosing the Holder option, it will not be necessary to establish a physical location in Brazil to start selling your products.
With Holder your products are hosted by Stone Okamont through the BRH (Brazilian Registration Holder) requiring only their registration, thus saving time and money. Learn more: Holder service.
After the regularization of the company, it becomes possible to register a laryngoscope in Brazil. For this, it will be necessary to present tests that prove the safety and effectiveness of the product. In addition, more specific information about the product will be requested, such as: composition material, components, form of hygiene, instructions for use and others. Learn more: Product registration.
Registering a laryngoscope in Brazil is a regulatory process that requires the advice of a competent adviser. Stone Okamont is the right advisor for you!
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Editor: Gabriela Batman Carvalho
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