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The Food and Drug Administration (FDA) Philippines, through the Center for Device Control, Radiation Health and Research (CDRRHR), has finalized a draft Administrative Order titled "Rules and Regulations Governing Issuance of Authorizations for In Vitro Diagnostic Medical Devices (IVD)."
To discuss this draft and gather input from stakeholders, the FDA is inviting representatives from the IVD industry to participate in a Virtual Public Hearing scheduled for September 2, 2022, at 2 p.m. via Google Meet. This hearing aims to provide services and solicit feedback from those who will be impacted by the proposed regulation.
Please note that there are 80 available slots for individuals wishing to participate, and each company may only send one representative.
For full information, please refer to the original source from the FDA Philippines
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- Medical Device Company Establishment Service
- Renewal and License Amendment
- Miscellaneous Certificates
- Post-Marketing Surveillance
- E- Catalogue
- Medical Device Trademark Management
- GDPMD (Good Distribution Practice for Medical Device)
- Regulatory Intelligence
- IDAK (Izin Distributor Alat Kesehatan)