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The Food and Drug Administration 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 FDA said the classification of medical devices is based on the Association of Southeast Asian Nations 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.
Food And Drug Administration Medical Equipment
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