How to issue AFE for healthcare products?January 22, 2021
AFE is a document that regularizes companies before Anvisa – National Health Surveillance Agency, allowing companies, institutions, bodies or establishments to work with health products, being they disposable mask, diagnostic tests, respirators, equipment, instruments, among others.
In this blog post you will know more details about AFE and how is the process to acquire the document at Anvisa.
What is AFE?
First, let’s understand better what is AFE.
The definition of AFE (Autorização de Funcionamento de Empresa) is Business Operation Authorization, and is summed up in an act of responsibility of Anvisa to regularize companies that wish to start working with health products.
The document is mandatory so that the company can start its work, subject to the penalty of warning or interdiction if it does not fulfill the obligations before Anvisa, following Law No. 6,437/1977.
In addition to AFE, the company that intends to work with health products with risk classes III and IV needs to issue the certificate of good practices with Anvisa to comply with all legal obligations before selling, manufacturing or importing.
Certificate of Good Manufacturing Practices (CBPF)
Anvisa’s certificate of good practice is a document that attests that the company complies with Good Manufacturing Practices.
It attests that the company follows all practices according to Anvisa and in accordance with the legislation in force and must be accompanied by the AFE.
Does my company need AFE for healthcare products?
The Business Operation Authorization is mandatory for every company that wishes to carry out activities such as importing, exporting, storing, distributing, manufacturing and transporting health products.
The authorization request is one of the first steps that a company must take, before carrying out its activities.
Learn more about regularizing your business.
How to issue the AFE for health products?
The Business Operation Authorization is requested from Anvisa before the company’s activities are carried out. See a step by step how to issue the AFE:
- Registration of company information;
- Petition for adequacy of tax status;
- Petition for the AFE concession process;
- Payment of the GRU federal fee;
- AFE process protocol;
- Publication of AFE in the Official Journal of the Union (DOU).
First, the process must be done from a register where the company will present all the necessary information, being as technical responsible, security manager or even the legal representative of the company.
The second step is to inform the size of the company where it is classified through its annual billing and by the commercial board, based on this information, the rates will follow. Petitioning is the process by which the company has an interest in requesting an event such as AFE.
Finally, the protocol with the fees to be paid is issued, after 48 hours the protocol is generated by the system related to the process and the joining of all documentation to be approved by Anvisa.
For greater security of companies, Licempre, as a company specialized in regulatory matters, takes care of the whole process, offering greater security and savings. Talk to us and learn how to regularize your company.