Boost to medical device classification

THE Food and Drug Administration (FDA) has formed a task force to intensify its efforts in classifying medical devices in the country.

Speaking on a radio program on Wednesday, FDA spokesman Pamela Sevilla said Task Force Obsidian will strictly enforce regulatory standards.

Sevilla said that as early as 2020, the agency had already made issuances to guide stakeholders and consumers on the classification of medical devices.

The task force will help in solving the problems in the approval or registration of stakeholders for medical devices.

The FDA will now be able to make the classifications based on the Asean Medical Device Directives, which classifies a device from A to D, depending on the risk it poses to the patients.

“Before they apply to the FDA, stakeholders should know right away, so that what they are applying is correct, because the downside is if the consumer buys the wrong classification of medical device, that’s because it did not follow the procedures of the FDA,” Sevilla said.

She said the FDA has a Zero Contact Policy for their clients and applicants, and they are holding conferences, conventions, and meetings with the Philippine medical industry.

“It’s important because the medical device industry, while it is not that known among our consumers, is regulated by the FDA, for the public to know. Because some members of the public may not know that facemasks, gloves, and other paraphernalia are also regulated by the FDA,” Sevilla said.

She admitted there are challenges in implementing the guidelines since stakeholders do not apply their devices for classification because of the confusion over what are the risks they are applying for.

“We are here to assist them, to guide them, so they do not get lost in the right track on what are the classifications they are applying for,” Sevilla said.

According to the FDA’s website, Task Force Obsidian “is expected to play an important role in fortifying the agency’s regulatory authority and setting new benchmarks for the industry. The final issuance of its work will mark a major milestone in enhancing the FDA’s mission to protect the health and well-being of the public.”