How to register needles with Anvisa?March 25, 2021
Needles are health products employed by professionals to give injections, medications, vaccines, and to draw blood. They can be handled intravenously or intramuscularly.
To make sure that the health professionals will be able to perform procedures that involve the use of needles with safety, these needles must be certified by INMETRO and then registered with Anvisa.
In this blog post, you will find out how to register needles with Anvisa.
What are needles?
Besides being used by health professionals in several activities, needles are also used in acupuncture and to make tattoos.
There are several needle calibers that can change according to the needle’s size and function. All needles can be used only once; therefore, they must be discarded after any type of procedure that generates piercing-cutting residues.
How to register needles with Anvisa?
Firstly, the needle must be certified by INMETRO. Once the technical tests are performed and the needle is approved, it receives a seal of the body, indicating that it is considered safe by the regulatory body.
After the INMETRO certification, the product must be registered with ANVISA.
Needles are considered by Anvisa as a correlate material of risk class II, that is, of medium risk. The needle manufacturing company does not need to obtain a manufacture good practice certificate, but we must stress that the company must be registered with Anvisa (AFE) before commercializing or importing the product.
Specifically for the registration of medical equipment of risk classes I and II, complementarily to the RDC Anvisa no 185/2001, the Normative Instruction no 13, of October 22, 2009, is adopted. For registration, the applicable resolution is the Anvisa Resolution RDC no 24, of May 21, 2009.
To register your company with ANVISA, you will need the Functioning Permit – VISA (Local Health Surveillance).
For more information read: how to register your company with Anvisa
Once your company is regulated, you will be able to register needles with Anvisa. To that end, you will need to present to Anvisa all information regarding the product, such as characteristics, type, functions, specifications, among other data, through a registration application based on the RDC Anvisa no 24/09.
The product will be tested and technical reports will be issued by professionals of the regulatory body. If necessary, complementary information will be requested.
Additionally, it is very important to inform if the product was manufactured by your own company or was imported. If the latter, the tests and reports already performed and issued by the importing company will be evaluated by Anvisa.
How to register with safety?
Now that you know how to register your company and product with Anvisa, let us find out how to register with safety. Many companies fail to register when they try to do it on their own. Do to their lack of experience, they lose both money and time, increasing the risk of not being approved due to some error in the process.
The consulting company Licempre performs regulatory processes to help companies with their registrations, facilitating processes, with less bureaucracy, greater speed and economy.
Do you want to know more about how to register products with Anvisa? Get in touch with us and talk with one of our experts.