FDA eases rules to expedite Customs release of imported respirators, other medical devices
Robie de Guzman • March 26, 2020 • 506
MANILA, Philippines – The Food and Drug Administration (FDA) has relaxed its rules to expedite the release of imported respirators, ventilators and other medical devices which are essential in responding to the novel coronavirus disease (COVID-19) pandemic.
In a letter dated March 23 addressed to Bureau of Customs (BOC) Rey Leonardo Guerrero, FDA Director General Rolando Enrique Domingo advised the bureau that importers of ventilators, respirators, and their respective accessories for commercial purposes need only to present copies of their license to operate.
“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 to customs release,” Domingo said.
“We hope that the measures being introduced would expedite the customs release of ventilators, respirators and their respective accessories which are vital in responding to the threat of COVID-19,” he added.
Foreign Affairs Secretary Teodoro Locsin, Jr. lauded the FDA’s move.
“No more FDA approval needed. No more excuses to delay release from Customs. Thank you all,” he said in a Twitter message which is accompanied by the FDA letter.
A similar rule for commercial imports and foreign donations of personal protective equipment such as face masks and head covers was also issued by the FDA earlier.
MANILA, Philippines — The Food and Drug Administration (FDA) is busy processing applications for licenses of coronavirus disease (COVID-19) test kits and all other products necessary in the country’s fight against the global pandemic.
The Department of Science and Technology (DOST), meanwhile, is focusing on research and development of treatment or vaccine against COVID-19.
Due to the volume of work and the high demand for additional workforce, President Rodrigo Duterte has allowed the two agencies to hire more personnel to join the government’s COVID-19 response.
“I have authorized these two offices — the FDA and the DOST — to employ as much as many that would be required to expedite [the processes] and to enable the agencies to work day and night. As I have said, we are fighting a war here, a crisis,” the President said in Filipino during his live address to the nation on Monday (April 27).
Meanwhile in his Joint Congressional Oversight Committee report, the President noted that the Department of Budget and Management (DBM) already approved the hiring of additional workers for the Department of Health (DOH).
The DOH requested for additional 15,757 healthcare professionals who will be given three-months contract of service and will be funded with P2.7-billion.
The DOH said seven hospitals have signified their request for additional medical personnel to cope with the volume of workload in relation to the COVID-19 pandemic. MNP (with reports from Rosalie Coz)
MANILA, Philippines – The Bureau of Customs (BOC) has shipped back to South Korea some 2,676 metric tons (MT) of waste materials that were stored at the PHIVIDEC Industrial Authority premises in Misamis Oriental since 2018.
In a report to Finance Secretary Carlos Dominguez III, Customs Commissioner Rey Leonardo Guerrero said the shipment was part of the 5,176.91 MT that the South Korean government committed to help send back to their country after these were illegally exported to the Philippines in July 2018.
The waste materials consist of plastic synthetic flakes that were illegally imported by the Cebu-based Verde Soko Philippines Industrial Corp.
Guerrero said the garbage was shipped back in 151 forty-footer containers.
The first batch of 51 containers was re-exported to Korea on Jan. 25, 2019, followed by another shipment of 50 containers on Jan. 15 this year.
A third batch consisting of 50 containers was shipped to Korea last March 21.
“The re-exportation took some time because the wastes have been exposed to natural elements of heat and rain, which made it difficult to re-bag and stuff inside the containers,” Guerrero said in his report.
The remaining 2,500 MT of wastes were initially scheduled to be shipped back in March but it was delayed due to the Enhanced Community Quarantine (ECQ), according to Guerrero.
The community quarantine has forced most people to stay in their homes as the operation of public transportation and classes in schools were suspended. Most government offices have implemented a skeleton force while other employees were ordered to work from their homes.
“Rest assured that the Bureau will undertake all the necessary means, within the bounds of the law, in order to expedite the re-exportation of these wastes,” Guerrero said.
The Food and Drug Administration (FDA) has approved 16 coronavirus disease (COVID-19) rapid antibody test kits for commercial use.
“These applications have completed necessary documentary requirements and have undergone review and evaluation by the FDA,” according to the FDA in a statement.
The rapid test kits detect the presence of antibodies in an individual’s blood or serum. This is to determine if the individual has previously contracted the coronavirus and developed antibodies for it.
FDA Director General Eric Domingo previously said they want people to have access to the testing kits but the testing should still be subjected to proper protocols.
“The rapid test kits will yield a faster result compared to PCR based kits, but it is important that a trained health professional will evaluate and interpret the results,” he said.
The FDA, moreover, reminds the public that each rapid test kits have different specifications and the tests should still be administered by trained health professionals.
“The agency reiterates that these kits are strictly for medical professional use only and not intended for personal use,” the statement reads.
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