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FDA Philippines Guidelines: Importation, Distribution Records, and Reporting Obligations for Medical Devices
The Food and Drug Administration (FDA) Philippines has issued a draft guideline for public comments outlining regulatory expectations for medical device establishments regarding record maintenance and post-market reporting. The draft provides structured guidance on importation and distribution records, product complaint handling, adverse event reporting, and field safety corrective actions (FSCAs). This guidance aims to strengthen traceability, post-market surveillance, and
Sharan Murugan
14 hours ago3 min read
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