How to register a scalpel at Anvisa?September 17, 2020
The scalpel is a medical device used in many surgical procedures. As it is an instrument used in surgeries, it is considered mandatory to register at Anvisa, obeying all procedures and regulations.
In this blog you will know how to register scalpel at Anvisa, and how Licempre can help you make the process less bureaucratic and more secure.
What is the scalpel?
First, let’s understand what the scalpel is.
The scalpel is a cutting instrument, composed of a sharp blade where it is used by doctors in surgical procedures. The type of holder and blade may vary depending on the function of each instrument.
As it is a cutting equipment, it is considered by Anvisa to be a health product, risk class III, that is, its registration is mandatory.
Why should I register the scalpel at Anvisa?
The instrument, as previously mentioned, can cause damage to health, mainly because it is part of surgical operations. Thus, the instrument can only reach the market after it has been approved by Anvisa and made its registration following all stages of regulation.
It is not possible to sell any scalpel that is not approved by Anvisa, because the regulatory body is a guarantee of instrument quality and safety, both for those who will use it and for the patient who will be subject to operation.
How to register a scalpel at Anvisa?
Because it is an instrument that has a cutting blade, the scalpel is considered a risky medical equipment. This means that the tests, the information, the Anvisa technical reports are more complex and this can generate more bureaucracy when registering the product. It must pass all tests and technical reports until he is approved.
The process to register the scalpel at Anvisa consists of the delivery of all information, reports, dossier, images, packaging, among others and, after Anvisa’s analysis and approval of the product with its control number, the product is able to be marketed and used.
To learn more about the registration of hospital products you can access our blog post: 5 steps for regularizing hospital products
Why hire a consulting firm in regulatory affairs?
In more complex cases or in simpler product certifications, advisory and consultancy in regulatory matters allows your process to be carried out with more tranquility, less bureaucracy, more security and agility.