FDA creates task force to enhance medical devices regulation

The Food and Drug Administration (FDA) has formed a task force assigned to improve regulation of medical devices in the country.

The Task Force Obsidian was established to help stakeholders identify the proper classification of medical devices submitted for FDA approval, including items such as stethoscopes, surgical scissors, syringes, ventilators, surgical masks, and gloves.

"Itong problema na ito ay nagi-stem sa approval or registration ng ating stakeholders for medical devices. The most common na nae-encounter ng FDA is hindi po sigurado ang ating stakeholders kung ano ang classification ng medical devices na kanilang ginagamit," said FDA spokesperson Pamela Sevilla in Bagong Pilipinas Ngayon on Thursday.

(The problem we have noticed stemmed from the approval or registration for medical devices by the stakeholders. We commonly encounter stakeholders who are unsure on what classification they should apply for their medical devices.)

The FDA said the classification of medical devices is based on the Association of Southeast Asian Nations (ASEAN) Medical Device Directive, an agreement that harmonizes the regulation of medical devices across the region.

"With this regulation, makikita natin kung ano yung mga classification, base sa ASEAN Medical Device Directive, mayroon po tayong classification na A to Z na nagngangalan pong 'low-risk medical devices' hanggang 'highest risk medical devices,'" Sevilla added.  

(With this regulation, we can identify the classification based on the ASEAN Medical Device Directive. From A to Z, we can classify them from 'low-risk medical devices' to 'highest risk medical devices.')

The agency warned that medical devices that are improperly classified may not have been approved by the FDA.

"Kung makabili po ang ating consumers o publiko ng maling classification ng medical devices, ayan po ay hindi nakakasiguro na dumaan sa Food and Drug Administration," Sevilla said, noting that some medical devices come from overseas.

(If the consumers or the public buy incorrectly classified medical devices, they are not assured that these underwent the FDA approval process.)

In a separate statement, the FDA said the Task Force Obsidian will streamline the application process and recommend corrective actions to safeguard against non-compliance.

Regular updates will be delivered directly to the Office of the Director General. — VDV, GMA Integrated News