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PHILIPPINES DELAYS LAUNCH OF NEW MEDICAL DEVICE REGULATIONS

The Philippines Food and Drug Administration (FDA) intended to implement the first two phases of the new medical device regulatory system (known as Administrative Order 2018-0002) on April 11, 2019, however the implementation date has been delayed.  Extra time is needed for the CDRRHR to finalized guidelines for classification and grouping, etc.

PHILIPPINES TO HOST ASEAN MEDICAL DEVICE COMMITTEE MEETING / TRAINING

The 8th ASEAN Medical Device Committee Meeting (AMDN) will take place in Manila from August 4-8, 2019.

Philippines Proposes New Fees for Medical Device Registration

The Philippines Department of Health published a draft schedule of fees to be charged for medical device registrations under the new Rules next year. As per Administrative Order 2018-0002, medical devices will be classified by increasing risk from A to D.