The importation of medical device samples is a process that involves several stages and regulatory requirements. This process can be carried out in two main ways: via express courier import (simplified regime) or through the traditional direct import method via SISCOMEX (normal regime). Each of these methods has its own characteristics, which can impact the speed, complexity, and costs involved.
In this article, we will explore the step-by-step process of importing samples, highlighting the differences between the two regimes and addressing the applicable taxes in each case.
Step by Step Process for Importing Medical Device Samples
- Sample Identification: The first step is to clearly identify the sample to be imported. This includes the technical description of the medical device, intended use, and manufacturer information, as well as batch number and expiration date. ANVISA requires that all documentation is aligned with health surveillance guidelines to ensure product safety.
- Requirement Consultation: After identifying the sample, it is necessary to consult ANVISA (National Health Surveillance Agency) requirements for the medical device in question. Depending on the product, prior health registration may be required, which is mandatory for moderate to high-risk medical devices (Class II, III, and IV). Low-risk products, such as Class I, may be exempt from registration, provided they meet certain criteria.
- Product Registration: Medical devices that present moderate to high risk require health registration with ANVISA before they can be marketed or used in Brazil. The registration ensures that the product complies with all safety, efficacy, and quality standards.
- Registration Exemption: Class I products considered low risk, may be exempt from health registration if they do not have characteristics that require more extensive regulation.
- Choosing the Importation Mode: With the regulatory requirements defined, it’s time to choose the most appropriate import regime: Express Importation via Courier (Simplified Regime) or Direct Import via SISCOMEX (Normal Regime). This choice depends on factors such as the value and volume of the sample, as well as the complexity of the necessary procedures.
- Express Importation (Courier):
This regime is ideal for samples of lower value or volume. Simplified importation by courier is carried out by international carriers (such as DHL, FedEx, or UPS), being a faster and less bureaucratic process.
- Simplified Taxation: The import tax under the simplified regime is fixed at 60% on the total value of the goods (including freight and insurance) plus the ICMS of the Clearance State and Administrative Fees and Storage. This percentage applies regardless of the type of product. For goods up to $50.00, sent from individual to individual, there may be a tax exemption.
- Documentation: The required documentation is simplified, and customs clearance is quicker. This regime is recommended for importing samples whose value and volume do not justify the complexity of the traditional regime.
- Advantages:
- → Quick and simplified process.
- → Less bureaucracy.
- → Fixed 60% tax.
- Traditional Importation (SISCOMEX):
For samples of higher value, volume, or requiring specific registrations, traditional importation via SISCOMEX is more suitable. This process is more complex, requiring the formalization of the Import Declaration (DI) and compliance with all customs clearance stages.
- Customs Clearance Stages: Customs clearance is the process of releasing imported goods by customs, ensuring that the products
- comply with Brazilian regulations and that all taxes have been duly paid.
- Import Declaration (DI) Registration: The importer must register the DI in SISCOMEX, providing all details of the goods, such as description, value, quantity, and tax regime.
- Documentary Review: The Federal Revenue analyzes the documents presented, including the commercial invoice, bill of lading, and, if necessary, import license (LI) and health certificates.
- Channel Assignment: After the DI registration, the goods are directed to one of the parametrization channels (Green, Yellow, Red, or Gray) for documentary and/or physical inspection.
- Green Channel: Automatic release of goods without physical or documentary inspection.
- Yellow Channel: Detailed documentary review.
- Red Channel: Documentary and physical inspection of the goods.
- Gray Channel: Physical, documentary inspection, and more rigorous analysis to investigate possible fraud or irregularities.
- Tax Payment: In this regime, taxes vary according to the nature of the product and its fiscal classification. The taxes include:
- Import Tax (II): Variable percentage.
- Tax on Industrialized Products (IPI): Percentage according to the type of product.
- PIS/Cofins: Variable percentage.
- ICMS: State tax that varies according to the destination state.
After the inspection and compliance with all requirements, the Federal Revenue releases the goods to the importer.
- Advantages:
- → Rigorous control.
- → Suitable for higher value goods.
- → Necessary for products that require specific registrations or import licenses.
- Registration and Documentation: Regardless of the chosen import modality, it is essential to ensure that all documentation complies with ANVISA requirements. This includes but is not limited to the commercial invoice, certificate of origin, import license (when applicable), and health documents.
- Tax Payment: In both cases, the payment of import taxes must be made. In courier importation, the tax payment process is more simplified, while in traditional importation, taxation may vary according to the product and declared value.
- Courier Importation (Simplified Regime):
- → Fixed tax of 60% on the total value of the goods (product + freight + insurance) plus the ICMS of the Clearance State and Administrative Fees and Storage.
- → Exemption for goods up to $50.00 sent from individual to individual.
- Traditional Importation via SISCOMEX (Normal Regime):
- → Variable taxation (Import Tax, IPI, PIS/Cofins, ICMS) depending on the product’s fiscal classification.
- → Requires greater formalization and detailed documentation.
- Customs Release and Sample Receipt: After the approval of documentation and payment of taxes, the cargo is released by customs and delivered to the importer. In express importation, delivery time can be significantly reduced compared to traditional importation.
Comparison Between Express Importation (Courier) and Importation via SISCOMEX
| Aspect | Express Importation (Courier) | Traditional Importation (SISCOMEX) |
| Release Time | Fast (5 to 10 business days) | Slow (10 to 12 business days or more) |
| Documentation | Simplified | Complex |
| SISCOMEX Registration | Not required | Mandatory |
| Operational Cost | Higher per volume | Lower per volume |
| Cargo Tracking | Limited | Detailed |
| Taxation | Simplified (taxes included) | Calculated according to DI |
| Suitable for | Small and urgent samples | Larger and higher value samples |
Conclusion
Choosing the correct import flow for medical device samples depends on the specific needs of the process, whether due to urgency or the type of product. Express importation is ideal for emergency situations, while the SISCOMEX route offers greater control and is more suitable for complex and higher-value cargoes.
For more details and guidance on importing medical devices and samples, contact Brisa Advisors for specialized regulatory support.
Find out more about BPO in RA!
The above text was collaborated on and reviewed by Alexandre Souza Rego.
*Budget for registration ownership transfer, Market Access Strategy, and BPO in RA services for your company: www.brisa.com.br
