To expedite customs release of ventilators, respirators and accessories, to be used in treating patients infected with the COVID-19, the following procedures shall be observed:
For ventilators, respirators and their respective accessories which are imported to the country for commercial purposes, importers thereof need only to present their copies of their License to Operate (LTO) to the BOC prior customs release.
On the other hand, foreign donations of ventilators, respirators and their respective accessories to be used in the treatment of COVID-19 patients need not require FDA clearance prior customs release.
Said procedures shall be in effect until otherwise lifted. For your guidance.
Attachment:-> FDA Advisory No. 2020-449