00:00To ensure the quality of medical devices in the market, the Food and Drug Administration, FDA, has strengthened its classification.
00:08In an interview with Bagong Pilipinas Ngayon with Attorney Pamela Sebelia, FDA spokeswoman,
00:15she said that the task force Obsidian has formed an agency that will investigate the classifications of medical devices that are being sold in the market and used by the public.
00:27The agency's aim is to alert those who apply for accreditation and approval in the FDA for the medical device they are selling.
00:36And to ensure that the medical device's classification is effective, safe, and correct for consumers to buy,
00:43such as quality face masks, surgical gloves, and many more.
00:47According to the FDA, they are also consulting the medical devices industry to inform their new policy.
00:57In 2024, we saw the importance of how to bring this to our public.
01:06How will they know the classifications that I mentioned using medical devices.
01:14With this regulation, we will see the classifications based on the ASEAN Medical Device Directive.
01:22We have a classification A to B, which is low-risk medical devices to high-risk medical devices.
01:30Before applying to the FDA, every stakeholder should know this so that they can apply correctly.
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