Materials for health are important products that aid in treatments and prevention of diseases. Therefore, Stone Okamont will guide you on how to regulate health materials with ANVISA.
Because they are directly linked to health, there are many specifications and requirements of the Brazilian Health Regulatory Agency that can hinder the regulation process for people who are not accustomed to the regulatory language.
But do not worry! Stone Okamont's expertise ensures excellent results, quickly and at reduced costs! Check out our material and learn how to regulate health materials at ANVISA.
Health materials are non-active products that have the purpose of assisting in the treatment and prevention of diseases. They are also called correlates.
But before starting the process for regulate health materials at ANVISA, you will need to regularize your company.
To regulate health materials with ANVISA, the first step is to obtain the Operating License for your establishment.
It is acquired from a survey carried out by VISA, that is, the Local Sanitary Surveillance.
The License is a documentation that establishes whether the establishment has technical and operational conditions to carry out its activity.
The AFE, Operation Permits, is mandatory to regulate health materials with ANVISA.
It is granted by the Brazilian Health Regulatory Agency, through publication in the Official Gazette, after analysis and approval of the petition sent by the company.
The acquisition of the AFE means that the company operates in accordance with Brazilian law and is able to operate throughout the national territory.
The beginning of the regulation process for health materials with ANVISA is to frame your product in some Risk Class.
The Risk Class takes into account the characteristics and complexity of the product, with I being the lowest and IV being the highest.
Complementary to the Risk Class, the Brazilian Health Regulatory Agency established a set of rules related to the indication and purpose of the product.
The first four rules are directed to non-invasive materials, those that do not penetrate the human body.
The next three are related to invasive materials, that is, those that penetrate partially or totally into the human body.
There are also additional rules that involve materials with special characteristics, such as condoms and blood bags.
After classification of the product, if it has been classified in Risk Class III or IV, the company must obtain a Certificate of Good Manufacturing Practices to regulate materials for health use with ANVISA.
The certification comes from an analysis of the Quality System implemented in the company.
The System is composed of manuals, procedures and standarts that optimize the operation and guarantee the quality in the production.
To request the regulation of materials for health with ANVISA will be necessary to follow some rules of the Brazilian Health Regulatory Agency.
There are forms that must be filled with the technical data of the product, as well as documents of foreign origin and collection of tax.
Some materials, such as condoms and syringes, also require the certification of Inmetro, the National Institute of Metrology, Quality and Technology.
The regulation of health materials with ANVISA follows many types of classifications that may confuse people who are not accustomed to the regulatory language.
Stone Okamont has experience and trained consultants who are ready to serve your company and provide intelligent solutions!
We are the best option for your regulation of health materials with ANVISA!
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