Philippines Looks To Expedite Approval Of Devices That Already Have ASEAN Approvals

The Filipino FDA is now circulating a document that will allow abridged processing of device applications in the Philippines if the device has already been approved in another ASEAN country. Abridge processing refers to a quicker evaluation with respect to AMDD-CSDT requirements. Of course, a shorter approval route in the Philippines requires that the exact same device has been approved in another ASEAN country, and the exact same technical requirements were submitted. Shorter processing will only apply to devices classified as B, C, and D. If there are any problems with the device in other ASEAN countries, or other issues arise, the Filipino government will have the right to waive abridged processing.