FDA launches Task Force Obsidian for medical device classification regulation | ABS-CBN
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FDA launches Task Force Obsidian for medical device classification regulation
FDA launches Task Force Obsidian for medical device classification regulation
MANILA -- The Food and Drug Administration (FDA) has launched Task Force Obsidian to focus on the classification of medical devices in the country.
MANILA -- The Food and Drug Administration (FDA) has launched Task Force Obsidian to focus on the classification of medical devices in the country.
The technical working group is looking to enhance the regulation of medical devices and to strictly enforce standards for consumer and manufacturer protection.
The technical working group is looking to enhance the regulation of medical devices and to strictly enforce standards for consumer and manufacturer protection.
FDA Spokesperson Atty. Pamela Sevilla said in an interview in Bagong Pilipinas Ngayon that the task force shall develop policies and guidelines on the classification of medical devices.
FDA Spokesperson Atty. Pamela Sevilla said in an interview in Bagong Pilipinas Ngayon that the task force shall develop policies and guidelines on the classification of medical devices.
“The most common na na-encounter ng FDA, hindi sigurado ang FDA o stakeholders kung ano ang classification ng medical devices. Bago makapag-apply sa FDA, dapat malaman ang ina-applyan. Kung makabili ang consumer ng maling classification ng medical device, ‘yan po ay hindi nakasisiguro na dumaan sa FDA,” Sevilla said.
“The most common na na-encounter ng FDA, hindi sigurado ang FDA o stakeholders kung ano ang classification ng medical devices. Bago makapag-apply sa FDA, dapat malaman ang ina-applyan. Kung makabili ang consumer ng maling classification ng medical device, ‘yan po ay hindi nakasisiguro na dumaan sa FDA,” Sevilla said.
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(The most common problem that we encountered is that the FDA and other stakeholders are unsure of the classification of medical devices. Before one can apply for the FDA, they must know what they are applying for, If consumers buy a medical device with the wrong classification, we can't be sure that it passed through the FDA.)
(The most common problem that we encountered is that the FDA and other stakeholders are unsure of the classification of medical devices. Before one can apply for the FDA, they must know what they are applying for, If consumers buy a medical device with the wrong classification, we can't be sure that it passed through the FDA.)
FDA will conduct information dissemination to its clients and applicants to educate them on its regulations relative to the ASEAN Medical Device Directive.
FDA will conduct information dissemination to its clients and applicants to educate them on its regulations relative to the ASEAN Medical Device Directive.
“Ang medical device industry, bagamat hindi masyadong sikat, ‘yan po ay nire-regulate ng FDA sa kaalaman ng lahat. Even our face masks, even our gloves ,mga paraphernalia dapat nireregulate din ng FDA,” Sevilla said.
“Ang medical device industry, bagamat hindi masyadong sikat, ‘yan po ay nire-regulate ng FDA sa kaalaman ng lahat. Even our face masks, even our gloves ,mga paraphernalia dapat nireregulate din ng FDA,” Sevilla said.
(Although it is not that well-known, the medical device industry is being regulated by the FDA. Even our face masks, even our gloves, our paraphernalia must be regulated.)
(Although it is not that well-known, the medical device industry is being regulated by the FDA. Even our face masks, even our gloves, our paraphernalia must be regulated.)
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