Administrative Resolution No. 0020/2025, published by the National Authority of Health Regulation (ANRS) on October 10, 2025, incorporates the importation of medical devices for human use into the Nicaragua Single Window for Foreign Trade (VUCEN) platform.
The regulation entered into force on October 13, but its implementation will be gradual, as those devices that already have a valid sanitary registration are incorporated into the system. The Medical Devices Directorate will notify the sanitary managers of each company when their products are enabled to begin the digital procedure.
Main scope of the resolution
This measure is part of the national digitalization process that the ANRS has been applying in several regulatory procedures. With the use of VUCEN, companies will be able to manage import permits in a centralized way and with greater traceability.
The resolution includes:
- Requirements for managing users within the VUCEN platform.
- Steps to follow to process the online import permit.
- Specific conditions that invoices must meet to be approved by the ANRS.
- Review and appeal mechanisms in case of rejections.
- Applicable sanctions in case of non-compliance.
Regarding invoices, the same guidelines established in Administrative Resolution No. 0024/2024 are essentially maintained, such as:
- Complete description of the medical device.
- Indication of the valid sanitary registration number.
- Country of origin and batch number.
- Invoices without abbreviations, without supplementary attachments to complete data, and without mixing other types of products.
The resolution clarifies that it only applies to medical devices. Reagents, accessories, or raw materials that do not require sanitary registration continue under the previous regulation and are not included in this digitalization phase.
Positive implications
The incorporation of import permits into a digital system represents a significant improvement for the country’s sanitary management. Among the most relevant benefits are:
- Greater administrative efficiency:
It allows for reduced submission, review, and approval times for applications. - Better traceability:
Digitalization facilitates the monitoring of each procedure, which increases transparency. - Strengthened sanitary control:
By requiring valid sanitary registration and detailed invoicing, it ensures that imported devices meet minimum safety and quality criteria. - Reduction of in-person burdens:
Dependence on physical procedures is reduced, which simplifies processes for both companies and the ANRS. - Better document organization:
The electronic format requires greater clarity and precision, which reduces the margin of error and improves regulatory review.
Challenges associated with implementation
Although it represents a significant advance, the transition toward this system poses certain challenges that must be properly managed to ensure its success.
Among the main challenges are:
- Adaptation curve for companies:
Many will need to adjust internal procedures to comply with invoicing requirements and document uploading in digital format. - Gradual adoption:
Since not all devices will be enabled from the start, an intermediate phase may arise with differentiated treatments among companies. - Technical capacity of the system:
The VUCEN platform must operate with stability and sufficient support to avoid delays or errors in processing applications. - Need for constant supervision:
The ANRS will have to reinforce document verification and validation of sanitary registration to avoid inconsistencies or attempts at fraud.
Conclusion
Administrative Resolution No. 0020/2025 constitutes a decisive step in modernizing sanitary control in Nicaragua. By integrating the importation of medical devices into the VUCEN platform, the efficiency, transparency, and safety of the regulatory process are strengthened. Although implementation faces technical and operational challenges, the digital model represents a significant improvement for the sector and for the country’s sanitary oversight.
