FDA Clearance of Ventilators, Respirators and Accessories Prior Customs Release
The FDA Advisory No. 449-20, issued on March 23, 2020, outlines procedures to expedite the customs release of ventilators, respirators, and their accessories for COVID-19 treatment. Importers of these items for commercial purposes only need to present their License to Operate (LTO) to the Bureau of Customs (BOC) for clearance. Additionally, foreign donations of these medical devices do not require FDA clearance prior to customs release. These measures will remain in effect until further notice.
Law Information
- Reference Number
- FDA Advisory No. 449-20
- Date Enacted
- Subcategory
- Food and Drugs Administration of the Philippines
- Jurisdiction
- Philippines
- Enacting Body
- Congress of the Philippines
Full Law Text
March 23, 2020
FDA ADVISORY NO. 449-20
| TO | : | The General Public |
| SUBJECT | : | FDA Clearance of Ventilators, Respirators and Accessories Prior Customs Release |
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.
(SGD.) ROLANDO ENRIQUE D. DOMINGO, MDDirector General
Cite This Law
FDA Clearance of Ventilators, Respirators and Accessories Prior Customs Release, FDA Advisory No. 449-20, Mar 23, 2020 (Philippines)
FDA Clearance of Ventilators, Respirators and Accessories Prior Customs Release, FDA Advisory No. 449-20 (Phil. 2020)
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- Amendment to Include Respiratory Therapy Devices in the List of Medical Devices Covered by FDA Circular No. 2020-009, as Amended by FDA Circular No. 2020-009-AFDA Circular No. 009-B-20 • Apr 29, 2020 • Inter-Agency Task Force on Emerging Infectious Diseases (IATF-EID) Issuances
- FDA Allows Use of COVID 19 Test Kits Developed by Local ScientistsFDA Press Release • Mar 9, 2020 • Inter-Agency Task Force on Emerging Infectious Diseases (IATF-EID) Issuances
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