All health equipment of risk class III or IV must be registered with the National Health Surveillance Agency (Anvisa). The safety and effectiveness requirements will depend on the operating principle, mode of use and purpose of use of the health equipment, therefore, specific standards may apply, that is, you will have to consider these factors for the risk classification of your equipment. , and the same laws are applicable to imported products, thinking about it, Stone Okamont will help you how to register imported health equipment.
Registering imported health equipment can be a complex process for those who do not have this expertise, which is why we have prepared this blog to explain the steps in a simple way and with zero bureaucracy.
What are health equipment?
Among the health equipment some are: x-ray equipment, ultrasound equipment, tomograph, magnetic resonance equipment, Electro scalpel, equipment for use in aesthetics, etc.
Company regulation for import
The first step to be able to register imported health equipment is for your company to have Anvisa Authorization (AFE) for this purpose.
Let's go, step by step to obtain an AFE importer of Health Products from Anvisa:
1- Firstly, you must have an operating permit from the city hall
In order to open a company, it will be necessary, among other documents, the Social Contract with the medical product import activity described in the Corporate purpose, CNPJ Card with the National Code of Economic Activity - CNAE, which includes such activity.
2- Sanitary License
If you are going to store medical equipment for health, it will be necessary, before requesting the Sanitary License, to request the Evaluative Technical Report - LTA
The establishment must meet the requirements of Good Practices of RDC 665/2022.
Once the establishment is ready, you can call the Local Sanitary Surveillance inspection.
The inspectors attesting that the establishment meets the health requirements of the current legislation, issue the Inspection Report with a satisfactory conclusion.
3- Company Operating Authorization (AFE) 3- Company Operating Permit (AFE)
The AFE is Anvisa's authorization necessary for the establishment to be able to import medical equipment.
In possession of the Sanitary Surveillance Inspection Report with satisfactory conclusion, the company may apply to Anvisa for the Operating Authorization for the activity of importer of medical/related products.
The AFE is the Anvisa authorization necessary for the establishment to be able to import medical equipment.
In possession of the Health Surveillance Inspection Report with a satisfactory conclusion, the company may request from Anvisa the Operating Authorization for the activity of importer of medical/related products.
4- Certificate of Good Manufacturing Practices - CBPF
The CBPF is the certificate issued by Anvisa attesting that the company meets the requirements of Good Practices in accordance with current legislation.
Is CBPF mandatory for all health equipment establishments?
The answer is no only risk III or IV healthcare product companies must obligatorily obtain the Certificate of Good Practices.
5- Product regularization
With the regularization of the establishment ready, the next step will be to regularize the product. Imported health equipment must comply with the same legislation as domestically manufactured products.
Class I and II health equipment will be notified to Anvisa and class III and IV health equipment will be registered with Anvisa.
How can we help you?
The process of registering imported health equipment can be too difficult for many, full of indispensable steps. Therefore, Stone Okamont offers consultancy and advice throughout the regulatory process, using the zero bureaucracy method and reducing the costs involved.
With a lot of experience, Stone Okamont carries out, in a much more economical way, the entire process of registration of imported health equipment so that your company is regulated by ANVISA without letting you get lost in the middle of so much bureaucracy and details.
