The activity of manufacturing or assembling of medical devices has been developed and strengthened in the country by companies under the free trade zone regimen (FTZR) for over ten years.
The National Environmental Technical Secretary (SETENA, for its acronym in Spanish) required these companies to operate under an environmental license, processed through the environmental evaluation document D1. For that reason, most of the companies in the country that fabricate medical devices in industrial parks have an active license for their operation phase. Additionally, they have had to deposit an environmental bond and name a comptroller, registered before SETENA, in charge of conducting periodical on-site inspections, preparing reports and keeping an environmental logbook updated.
Nonetheless, SETENA modified this criterion based on Resolution No. 1462-2018-SETENA of July 17th of 2018. The resolution establishes that projects located inside free trade zones (industrial parks) that have an environmental license, with infrastructure already built, and the operations of these projects are not included in Annexes 1 and 2 of the Executive Decree No. 31849, will not require an Environmental Impact Evaluation (EIA, for its acronym in Spanish). It is important to carefully analyze the activities that will be carried out to confirm if the EIA has to be obtained or not.
If the EIA before SETENA is not applicable, we recommend taking precautions to avoid setbacks regarding other permit procedures. It is still usual for other state authorities to request the environmental license from manufacturing companies even when operating under the FTZR and meeting the requirements established in Resolution No. 1462-2018.
If your company meets such requirements and is operating under a valid environmental license, requesting the technical closure of the activity before SETENA could be an option. The developer must be up to date with its obligations before SETENA.
It is important to remember that even when the EIA does not apply, the project and its developer are subject to compiling with the remaining environmental regulations of the country. Prevention is key to avoid environmental damage. This requires understanding the legal framework and its implementation, as well as looking for continuous improvement in the management of any industrial operation.
By Luciana Pineda
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