Products that’re direct to health as equipment, materials and products for diagnosis, when regularized receives a registration number that should be available on it’s labeling, so that the user can use this reference to consult it’s regularity.
A hospital bed is a care device adapted to the needs of patients whose health requires long periods of rest. The product is also used as a means of transporting patients to exam rooms, surgery and ambulances.
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By regularizing your business or product, you'll come across multiple acronyms during regulatory steps, and this content will help you understand these acronyms quickly and conveniently. Here’re the basic steps you'll find.
To register an establishment or product, there’re several rules and steps that must be followed. Contact Stone Okamont, we do all the work for you from start to finish. No rework and unnecessary expenses.
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What is the first step to registering hospital beds at ANVISA?
In order to register hospital beds with ANVISA, it’s first necessary to obtain the Operating License.
The Sanitary License is issued by visa (Sanitary Surveillance) local or state, during the initial petition, in order to regularize the company with ANVISA (National Health Surveillance Agency).
Company Operating Authorization
The Company Operation Authorization (AFE) is one of the regulatory steps of mayor importance for the success of your business, and for this reason, it’s necessary to count on specialized technical support.
As it’s a requirement of ANVISA, companies working in the health area automatically need a Company Operating Authorization (AFE) to follow the service in legality, that’s, within the rules provided for by law.
Risk Class for medical equipment
ANVISA classifies hospital beds as products in I Risk Class.
That’s, the requirements of proof of safety and efficacy to register medical equipment in ANVISA, are quieter.
Product registration
All companies that offer products that may be harmful to health, such as medicines, pesticides, cosmetics, etc.; they need to be up to date with all regularizations with ANVISA.
The inspection of these products is carried out by Anvisa, the body responsible for the protection and recovery of health in the country. Your product can be notified or registered. All this’ll depend on the composition of your product and your risk rating at Anvisa.
In the case of hospital beds the product will be notified as correlinear. In this case, the degree of health risk of the product is small, and therefore ANVISA doesn’t require the entire bureaucratic process of registration. But this does not mean that the product will be "discarded" in the eyes of the National Health Surveillance Agency: every product exempt from registration needs to be notified to ANVISA.
How to register a product in ANVISA with efficiency, agility and economy?
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