How to register a mammograph at Anvisa?September 03, 2020
The mammograph is a medical device used in mammography exams to identify and prevent breast cancer using this X-ray machine. Do you know how to register the mammograph at Anvisa and why is the registration so important?
The companies that manufacture this equipment must register the mammograph with Anvisa, which is mandatory for its commercialization and use.
In this post you will know what it is and how to register the mammograph at Anvisa in a practical and safe way.
What is a mammograph?
The mammogram exam is an important exam that must be done to identify the early diagnosis of breast cancer, increasing the chances of successful treatment.
The mammograph is the X-ray equipment that performs this type of examination, generating the breast radiographs for the doctor’s evaluation.
How to register mammograph at Anvisa?
Every company, whether a manufacturer or an importer, that sells health equipment needs to offer security to the end consumer, which is why product registration is so important.
Anvisa as a regulatory body, certifies whether the product is fit for sale or not after undergoing all technical analyzes, tests and documentation approval, among others.
According to Anvisa, the product registration is:
The registration is the legal act that recognizes the adequacy of a product to the sanitary legislation, and its concession is given by Anvisa. It is a control carried out before commercialization, being used in the case of products that may present possible health risks.
For products subject to health surveillance to be registered, it is necessary to meet the criteria established by laws and the specific regulations established by the Agency. Such criteria aim to minimize any risks associated with the product.
The manufacturer or importer is responsible for the quality and safety of the products registered with Anvisa.
For the product to be registered, the company must be registered by Anvisa, that is, have the AFE – Authorization for the Operation of the Company approved.
Read more about company registration in our post: How to register your company with Anvisa.
Is registration mandatory?
The mammograph is a health device that, according to Anvisa, fits the Risk Class III. Thus, the registration of all equipment belonging to this group is mandatory, in addition, the factory must have the CBPF – Certificate of Good Manufacturing Practices issued by Anvisa and also the certification of the factory and equipment issued by Inmetro; the registration with Anvisa will be concluded after the regulation of the mentioned documents.
Read more in our post: Registering health products, how is it done?
Can I register mammograph at Anvisa alone?
When the company needs to register a product it must pay attention to some important points.
First, it must be known that the product registration with Anvisa is composed of several steps that go from the delivery of the product information, petition, test phases and approval. Thus, when a specialized company like Licempre, the process is safer and more practical, as you will have full support from the specialized professionals.
You can learn more about the advisory in our post: Why choose a regulatory affairs company.
In addition, you save time and money because, since your process at Anvisa is not approved or an error occurs, this can generate additional costs that were not foreseen.
Licempre’s advisory and consultancy does all the work with less bureaucracy and more results. Have a question or want to know more about it? Talk to our team of experts, we are ready to assist you.