The importation of medical equipment faces several obstacles in Brazil. Nevertheless, the amount spent on imported items is much greater than what is exported. This article will explain the necessary steps to import this type of product.
Brazil imports a large amount of the products used in hospitals, clinics and medical offices. From syringes to MRI machines, it is fairly common for companies and professionals to choose foreign products over those manufactured in the country.
Some of the factors explaining this attitude are, advanced technology used in other countries, or even greater reliability on equipment from Japan or the United States. Price, as always, is also an important factor.
Anvisa, which is the National Health Surveillance Agency, and the federal government, have established tax reductions and exemptions for imported medical equipment, if bought by public or philanthropic institutions. The local industry is asking for changes since these sectors are responsible for 65% of the national demand.
On one hand, there might be tax exemptions for the importation of medical equipment, but on the other hand there are many difficulties faced by those interested in importing. In 2010, for example, Anvisa stated that only their own technicians were allowed to validate and approve the use of each product.
The inspection must be done in the countries of origin. Bearing in mind that the agency has a limited number of technicians and a much larger amount of importation orders, delays happen frequently, and in some cases the most advanced equipment cannot be imported because of this rule. It is not rare for the company to wait years to legally receive the products.
Recent adjustments have been made to change this situation. According to the agency, going forward:
- Anvisa might use information sent by foreign entities, so sending Brazilian technicians will not be always necessary.
- Simple products, like syringes or scissors, will no longer require pre-shipment inspection.
- The manufacturer will not need to wait for a certificate in order to start the inspection; both processes may begin simultaneously.
In addition to the documents usually required for importation, companies importing medical equipment need an operating permit — Autorização de Funcionamento, or AFE — issued by Anvisa. To obtain an AFE, companies as well as as a technical manager must be registered, pay fees, and be approved by the agency’s inspections.
The equipment must also be registered by the entity. This process requires several documents, many of which can be obtained directly from Anvisa. The documents are:
- Statement of company size
- Form of the importer of medical products
- Proof of payment of the health surveillance fee
- Model of the label
- Model of the operating instructions
- Technical report
- Product’s certificate of free trade abroad
- Authorization of the foreign exporter or manufacturer for the commercialization of the product in Brazil
- Proof of compliance with specific technical regulation
Some types of equipment may also require specific paperwork, such as INMETRO certification.
Most Imported Equipment
As previously stated, Brazil imports a large amount of medical equipment. Usually products that require more advanced technology come from abroad, but some simpler items are also bought from other countries. Some of the most imported equipment are:
- Orthopedic implants
- Large medical machines, such as MRI or X-Ray
- Lung ventilators