PH Philippinen
  • 11 - Medizintechnik

This AdministrativeOrder applies to all medical devices to be sold, imported, exported, manufactured, and usedin the Philippines, except in-vitro diagnostic and refurbished medical devices,
for both ofwhich separate Administrative Orders shall be issued.

"Guidelines Governing the Issuance of an Authorization for a Medical Device based on the ASEAN Harmonized Technical Requirements"

These guidelines shall cover Class B, C and D medical devices that are not included in the list of registrable medical devices in FDA Circular No. 2020-001 as amended by FDA Circular No. 2020-001-A. The Circular provides for specific timelines for relevant stakeholders to follow for Certificate of Medical Device Notification (CMDN) and Certificate of Medical Device Registration for Class B, C and D.

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