The entry into force of Executive Decree No. 44696-S-COMEX on August 14, 2024, introduced the “Regulation for the sanitary authorization of the entry of health products or their raw materials into establishments under the free trade zone and active improvement regimes,” streamlining the process for obtaining sanitary authorization for the re-entry or importation of sanitary interest products (SIP) and their raw materials into companies operating under these regimes.
The regulation establishes guidelines to regulate the procedures, conditions, and non-tariff requirements that companies must meet to use health products without the need for sanitary registration, provided these products are not intended for the national market.
Entry vs. Importation
Unlike traditional importation, entry allows companies to bring products into the special regime without applying the usual customs requirements.
- This facilitates the transit and use of goods in production processes intended for export.
- The measure reinforces the “extraterritoriality” of free zones, allowing products to enter without being considered part of the national customs territory.
Exemption from sanitary registration
Products that are entered do not require sanitary registration if they are exclusively intended for:
- Export or re-export.
- Transformation processes and logistical services within the free zones.
However, sanitary registration will be required in specific cases:
- Dangerous or unfinished chemical products.
- Products nationalized for distribution or consumption in the domestic market.
- Medications for use in people within the customs territory.
Simplification of procedures
Companies must submit their entry requests through the Single Window for Foreign Trade (VUCECR), attaching:
- Authorization Form for Unloading (FAD).
- Detailed commercial invoice.
- Transport documents.
In simple cases, the process can be automatically resolved within 24 hours, speeding up the entry of products and strengthening the export logistics chain.
Exclusions from the regime
The decree excludes several products due to sanitary or regulatory considerations:
- Narcotics and used biomedical devices.
- Products with national or international health alerts.
- Radioactive materials and hazardous chemicals without registration.
- Explosive goods and substances regulated by international treaties.
Before the implementation of this new regulation, companies under the free zone and active improvement regimes had to wait for the approval of various sanitary registrations by the Ministry of Health. This situation caused delays in the effective start of their operations. With this modification, the new regulation provides significant benefits to these companies by simplifying the fulfillment of their requirements.
daniela.quesada@garciabodan.com
Associate
García & Bodán
Costa Rica