Plumbific aprons or lead aprons are the garments used for the examination of x-ray. The aprons are for professional use, for patients and companions.
In the cases of professionals who work daily with these equipment, a differentiated apron with easy use is available within the operating rooms, since the product is made to bringmore comfort to the user.
All aprons must be registered with ANVISA (National Health Surveillance Agency) and the Ministry of Health, and in the cases of aprons for professionals it’s necessary to make available the Certificate of Approval in the Ministry of Labor.
Because they’re directly linked to health, there’re many specifications and requirements of ANVISA that can hinder the registration process for people who are not accustomed to regulatory language.
In order for your related product to comply with current legislation, it will be necessary to obtain: Operating License, Operating Authorization Company, in some cases Certificate of Good Manufacturing Practices and Product Registration.
Before you file an application for the plumbiferous apron registration with ANVISA,the first step is to obtain the Operating License for your establishment. It’s acquired from a survey conducted by VISA, the Local Sanitary Surveillance.
The License is a documentation that ascertains whether the establishment has technical and operational conditions to carry out its activity. Learn more here!
The AFE, Authorization for the Operation of Companies, is mandatory to register health materials in ANVISA. It’s granted by the National Health Surveillance Agency, upon publication in the Official Gazette, after analysis and approval of the petition sent by the company.
Obtaining AFE means that the company operates in accordance with Brazilian legislation and is able to operate nationwide. Learn more here!
The beginning of the process of registration of plumbiferous apron at ANVISA is to frame your product in some Risk Class. The Risk Class takes into account the characteristics and complexity of the product, being I the lowest and IV the highest.
In the case of aprons, the Risk Class is I, the lowest.
After the company's regularization we filed the application for product registration with the competent body. For this it is mandatory to present tests and reports that prove the safety and efficacy of the product in order to ensure that it will perform perfectly its function without causing any harm to the final consumer.
If you want to know more about how to register plumbiferous apron with ANVISA click here!
To register corretors, the experience and expertise of a competent company in regulatory advice is required. Stone Okamont is the right consultancy for you! Count on Stone Okamont to register a plumbiferous apron on ANVISA.
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Editor: Nayara Barillari
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