Hypodermic needles are used for medication administration: intravenous or intramuscular, and for the extraction of blood and fluids for in vitro diagnosis.
The hypodermic needle is classified by Anvisa (National Health Surveillance Agency) as a correlate risk class II - Medium risk. Companies that work with risk classification II products do not need to obtain a Certificate of Good Manufacturing Practices. This is mandatory for products with classification III - High risk and IV - Maximum risk. Learn more: Certificate of Good Manufacturing Practices.
Anvisa is the regulatory agency in Brazil responsible for regularizing companies and products related to: correlate, sanitizing, medicines, cosmetics and others. Any product of these segments when entering Brazil needs to be properly regularized before its sale.
Do you know what else is needed to sell hypodermic needle in Brazil? In this content we will briefly talk about all the regulatory processes to sell hypodermic needles in Brazil.
Steps to sell hypodermic needle in Brazil
Before selling a hypodermic needle in Brazil, it needs to be registered. To perform the Product Registration, it is necessary to present essential information for all types of products, such as tests that prove effectiveness and safety. Anvisa generally accepts tests and reports from the country of origin of the product, however, these can be judged as not sufficient and new tests can be requested.
Specific information about the type of product is required when registering a hypodermic needle at Anvisa, such as: instructions for use, disposal instructions, material composition, caliber and others.
But before registering the product so that it is possible to sell hypodermic needles in Brazil, the company needs to be regularized. See below options to achieve your regularization.
Option 1 - Company regularization
- To sell hypodermic needles in Brazil, the company must initially establish a physical location with all the criteria required by VISA and Anvisa.
- Operating License - VISA - (Local Health Surveillance). This step consists of adapting the physical structure. This adaptation must follow the guidelines of the RDC - (Resolution of the Collegiate Board) related to the activity practiced by the company in order to receive the visit of a VISA inspector.
- Operation Permits (AFE) - Anvisa. This process has a federal scope and must be protocoled in a physical and digital form. In this stage, fees are collected, documents are compiled, among others.
Option 2 - Holder Services
In addition to advising on all processes to regularize your company and product, we also offer the Holder Services option. With Holder Services you can bring your products without the need to establish a physical company. Stone Okamont, which already has a license and authorization with Anvisa, hosts your products, requiring only its registration. That way, you have the freedom to choose how many distributors you want to keep to sell hypodermic needles in Brazil. Learn more:
Talk to those who understand!
Sell hypodermic needle in Brazil is a process that requires a consulting with expertise in the subject due to regulatory bureaucracies. Stone Okamont is the right advisor for your business! Count on us to beat the bureaucracy and sell hypodermic needle in Brazil!
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