How to register an imported health equipment at ANVISA?

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.  If you want to import health equipment to Brazil, you will have to consider these factors for the risk classification of your equipment and the same laws are applicable to imported products. In this article, we will show you – step by step – 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 it is highly recommended you find a local partner to help you with that in a riskless way and with zero bureaucracy.

What products are classified as a health equipment?

Health products are all devices, including health materials and in vitro diagnostic products, used in medical, dental, physiotherapeutic or aesthetic procedures. Some of them are listed bellow:

  • Diagnostic kits for in vitro use considered health products: reagent for diagnosing infectious diseases, biochemical dosages, hormone dosages and test.
  • Materials for health use considered health products: joint prosthesis, syringe, hypodermic needle, vascular catheter, gauze, dental and orthopedic implant, heart valve, surgical instruments, etc.
  • Equipment considered health products: magnetic resonance equipment, CT scanner, electrocardiograph, ultrasound equipment, X-ray machine, electrostimulator, cardiac pacemaker and exercise bike.

COMPANY REGULARIZATION FOR IMPORT

The first step to be able to register imported health equipment is that your company has Anvisa Authorization (AFE) for this purpose.

Let’s go, step by step to obtain an AFE importer of Health Products from Anvisa:

1. Registration:

In order to access Anvisa’s services, interested companies must, first of all, register through the Companies Registration System and user registration through the Security System. 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.Definition of the Company’s Size:

During the registration process, an important step is the definition of the company’s size, given that it influences, for example, Anvisa’s surveillance rates. Companies can be classified into five groups: Large Size (I and II), Medium Size (III and IV), Small Size and Microenterprise, according to their annual gross revenue.

3. Petition

After registration, any request for services with Anvisa must be made by means of a petition, defined in accordance with the Subject Code and the Taxable Event. It is he who defines the fees that will be charged by Anvisa for the inspection process, and which vary according to the size of the company.

4. Payment of Fees

After defining the service, the company will need to pay the Sanitary Surveillance Inspection Fee (TFVS), according to the Generating Event of the Petition. There are some cases of exemption from TFVS, which can be consulted directly on the Anvisa Portal.

5. Protocol Generation and Monitoring

Finally, each petition with Anvisa generates a protocol number (Physical, Virtual, Mandatory or Optional) that must be used by the interested party to follow up on his request.

With the authorization granted by RDC nº 16/2014, importers of health products can import:

– Regularized products, when the company owns them;

– Regularized products, when they belong to a third party company that is also regularized.

IMPORT PROCESS

Check out the step-by-step process of importing health products:

1. Purchase Order

The importer in Brazil sends the purchase order to the supplier with information on the product to be imported, with the serial number, description, quantity, unit and total price, address and payment method.

2. Commercial Invoice:

Document issued by the exporter acknowledging the order and informing about product availability. It must contain the same information as the purchase order, in addition to details such as packaging, weight and bank details for payment.

3.Shipping Order:

Document forwarded to the carrier and the exporter, for shipment of the cargo.

4.Shipping Documents:

Exporter prepares all the documentation that will be sent with the products, including, in addition to the above documents, sterilization certificates (when applicable), inspection document by the exporter, Anvisa registration certificate and list of goods to be be sent.

5. Collection and Shipping:

The packaging of the products must contain information such as the name of the product; lot number; recipient; manufacturer’s name, city and country, purchase order number and information about storage and transport precautions.

6. Clearance:

With the arrival of the cargo, the customs broker hired by the importer starts the process of clearance, from the registration of the Import License, which will be analyzed by Anvisa and the customs authorities.

7. Sanitary Release:

Anvisa will analyze all documentation related to the cargo and decide whether to release or physically and documentally inspect the cargo.

8. Customs Clearance:

After release by Anvisa, the importer pays the due taxes and the process is analyzed by the Federal Revenue, being able to release the cargo; require document inspection or even document and physical inspection.

9. Labeling:

After releasing the goods, the importer is obliged to label the products following Brazilian standards, putting all the information in Portuguese.

10. Storage:

After labelling, the product is stored in the place stipulated by the importer, also following sanitary rules.

PRODUCTS THAT CAN BE IMPORTED

Inputs, raw materials, semi-finished and finished products can be imported, subject to the following requirements:

– Supplies, raw materials and semi-finished products for medical use, the process must be carried out according to procedure 4 of RDC nº 81/2008;

– Inputs, raw materials and semi-finished products for in vitro diagnosis, procedure 5.5 of RDC No. 81/2008 must be exercised;

– Finished products must follow procedures 4 and 5.5 of RDC nº 21/2008.

HOW CAN WE HELP YOU?

Novatrade is a company that is specialized in enabling international companies to expand and grow in Brazil. We have a team of specialists that will help you all the way with the main services you will need to start your operation.

We not only help you with the Anvisa certificate, but also take care of everything else, such as: having a CNPJ in Brazil, import door-to-door, import of record, bonded warehouse, supply chain, customs clearance, finance management and more.

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