The importation of health products can only be released after a monitoring process of the goods. This article outlines how this process works and the main documentation required for it.
The health products sector is composed by a large universe, with different levels of complexity. It includes simple infrared lamps to MRI equipments or reagent kits for HIV detection. Therefore, these products are utilized in the performing medical, dental and physiotherapy procedures, as well as, in the diagnosis, treatment, rehabilitation, or monitoring of patients.
Health products are very important in the country, however, the Brazilian industry isn’t able to produce for all of the national territory's demand for health products because it depends on their importation from other countries.
Which are the Health Products
Health products are the responsibilities of the National Health Surveillance Agency. All products registered in ANVISA can be found in a search tool offered by the Agency web page, but basically the products comprised in this classification are:
- Diagnosis Equipment: equipments for medical, dental or laboratory use, designated for the detection of information on human organisms to help clinical procedures.
- Therapy Equipment: equipments for medical, dentist or laboratory use designated to psychological treatment.
- Medical and Hospital Equipment: equipments for medical, dental or laboratory use, designated to support diagnostic, therapeutic or surgical procedures.
- Materials for Healthcare: medicines, drugs and pharmaceutical products.
- Disposable Materials: equipments for medical, dental or laboratory use, usable only once.
- Implantable Materials: equipments for medical, dental or laboratory use, designated to be placed wholly or partly in the human body through medical intervention, and remaining in the body permanently or long-term after the procedure .
- Products for In-Vitro Diagnostic: products used to conduct a qualitative, quantitative or semi-quantitative determination of a sample from the human body.
Since health products are subjected to the ANVISA monitoring, it must be analysed by this governmental body before being commercialized in Brazil. The analyses occurs in three steps:
- When it is required by the importer,
- Before the embarking of the good, and
- In the moment of the customs clearance.
Requiring Anvisa's Analyses
The importation of products of raw material, semi-elaborated, in bulk or finished forms are subjected to the Import License registry in SISCOMEX and to a Previous Embarking Authorization before it reaches customs for clearance. The importing company interested must forward to the ANVISA, an application for shipment authorization abroad, by filing a Petition to release the shipment abroad.
Documents for Embarking Authorization
Documentação obrigatória para apresentação à autoridade sanitária quando da autorização de embarque no exterior:
- Union Collection Guide (GRU)
- Declaration conceded by the owner of the Anvisa license authorizing the outsourcing of the importation
- Power of Attorney of the company holding the regularization of the product at ANVISA to the legal representative
- Information about the product and the importer company, with product and company regularization and the number of the Import License or of the Simplified Import License.
Customs Clearance Documentation
Mandatory documentation that must be presented to ANVISA in the customs clearance of the good:
- Petition for Sanitary Monitoring and Release
- Access Authorization for physical inspection, when required
- Commercial Invoice
- Load Recognition of the load embarked
- Declaration informing the batches and the date of departures
- Sterility Proof or Analytical Report of Quality Control of the batch issued by the manufacturer
- Power of Attorney of the company holding the regularization of the product at ANVISA to the legal representative, responsible for customs clearance
- Documento de Averbação or Registration Document that proves the entrance of the good in a Brazilian bonded warehouse and the product localization, issued by the legal representative of company managing the bonded warehouse where the product is stored.