How to register procedure glove at Anvisa?August 19, 2020
Medical equipment registration is mandatory for products belonging to the Classes III and IV. As determined by RDC nº 185/2001. The other equipment and materials are certified according to the requirements of Anvisa and INMETRO.
The certification guarantees the product’s quality and safety for the consumer as it becomes commercialized.
Next you will know what the product registration is and how to register the procedure glove with Anvisa quickly and safely.
What is product registration?
Product registration is the activity that recognizes the suitability of a product under the health legislation and its concession by Anvisa.
It can be said that the product registration is a type of control made by Anvisa so that the product fits within all requirements to ensure safety, quality, and good use by its consumers, without causing damage or health risks.
The responsibility of the products registered by Anvisa rests with the manufacturers and importers, remembering that before registering a product, the company must be already registered.
What is a procedure glove?
The procedure glove is a disposable material used by health professionals in clinical situations where there is the possibility of direct or indirect contact with blood, secretions, excretions and objects with body fluids.
Procedural gloves are different from surgical gloves. Surgical gloves are recommended in surgical procedures and in other medical situations such as childbirth, invasive radiological processes, among others.
The gloves can be made of synthetic material, latex, and can also be composed of nitrile, butyl, and other components.
How to register the procedure glove?
Before the registration of the procedure glove, the manufacturer or importer needs to have the company registration updated.
To register the procedure glove, it is necessary to send all documents and information related to the product and follow all protocols for product approval.
Why register with Licempre?
The collection of all information and delivery of materials for registration must be done in the best way for approval.
Petition errors can lead to losses. Therefore, having a company specialized in regulation allows you to have greater peace of mind, safety, agility, and less bureaucracy in the processes.
You can count on our team to answer all your questions. Get in touch and talk to our experts.