FDA eases rules to expedite Customs release of imported respirators, other medical devices
Robie de Guzman • March 26, 2020 • 228
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 Bureau of Customs (BOC) on Wednesday said it has seized P15 million worth of personal protective equipment (PPE) suspected to be smuggled in a series of operations in Manila.
The BOC said the PPEs were confiscated from three shops in Sta. Cruz, Manila that were jointly raided by the agents of the Customs Intelligence and Investigation Service (CIIS) and the Philippine Coast Guard (PCG) on Tuesday, March 31.
Authorities recovered various PPEs, including gloves, face masks (surgical and N95), and goggles that are suspected to have been misdeclared as general merchandise when imported into the country.
“Smuggled PPE may pose a health risk to users since such items may not comply with the safety standards set by the government rendering them not fit for human utilization,” the bureau said in a statement.
The BOC said the inventory of said products is ongoing, while store owners were given 15 days to present necessary documents to prove that the items were legally imported.
“If proven that the PPEs were smuggled the store owners may face charges of smuggling in relation to the provisions of The Customs Modernization Act (CMTA),” the BOC said.
“Although the Bureau is focused in expediting the importation of PPE and other medical supplies badly needed to combat the COVID-19 pandemic, the agency is also committed in ensuring that goods are within acceptable standards and are safe for the public use,” it added.
The BOC recently raided a shop allegedly selling PPE and alcohol at exorbitant prices online amid high demand for such medical supplies.
The Bureau of Customs (BOC) has announced it is planning to donate the seized overpriced medical supplies to the frontliners of the coronavirus disease (COVID-19).
BOC Assistant Commissioner Vincent Maronilla said they are already coordinating with the Department of Justice (DOJ) and the National Bureau of Investigation (NBI) to finalize on the donation of the seized medical supplies.
Last March 26, the BOC seized P5 million worth of overpriced personal protective equipment and alcohol from a store in Binondo, Manila.
“We’re finalizing some plans na mapabilis agad ang forfeiture ng mga na-raid ng NBI, at pati na raid namin last week na overpriced alcohol, para ma-donate na natin sa frontliners na nangangailangan (to expedite the forfeiture of the seized goods from NBI raids, including the overpriced alcohol we raided last week. This is to donate it to the frontliners who need it),” he said. AAC (with reports from Rosalie Coz)
MANILA, Philippines – The Food and Drug Administration (FDA) on Monday (March 30) said it has approved the use of five rapid test kits for novel coronavirus disease (COVID-19) in support of efforts to address the pandemic.
In a statement, the FDA said these point-of-care test kits are registered for use in countries with reliable regulatory agencies such as China and Singapore.
“We approve kits that are registered and used in countries with advanced technology and wide experience with COVID 19,” FDA Director General Eric Domingo said.
Domingo said the rapid test kits will yield a faster result compared with PCR-based kits, but he stressed that its results should be evaluated and interpreted by a trained health professional.
“We have to be very cautious in using these rapid test kits because they measure antibodies and not the viral load itself,” he said.
As a safety precaution, the FDA requires all rapid test kits to have the following product inserts or label: “This product is strictly for medical professional use only and not intended for personal use. The administration of the test and interpretation of results should be done by a trained health professional. Confirmatory testing is required.”
“The body takes time to develop antibodies and this might give a negative result for patients who have been infected but antibodies have not yet developed antibodies,” Domingo said.
“A positive result due to cross reaction with other bacteria or viruses is also possible, which is why a confirmatory PCR based test is still required,” he added.
The FDA also announced it has approved the SARS Cov2 kit by Gene Xpert from Abbott Laboratories.
This PCR-based test kit, the latest in the 17 kits approved for commercial use, can detect the virus within five minutes, according to the agency.
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