Philippines FDA Announces New Fee Schedule for Medical Devices

On November 29^th and 30th the Philippines FDA hosted a public forum to review and field questions on plans to change the fee schedule for processing registration applications as outlined in a recent draft Administrative Order (available here) and it’s corresponding Annexes. Newly proposed fees for medical devices can be found in Annex D.

Asia Actual personnel in Manila attended the meetings and participated in the Q&A. Below are some important notes and insights gained from the event.

Notable Updates to the Fee Schedule

First, the proposed price increases will be significant.  The current registration fee for medical devices of all risk classifications is approximately US$150.  The new pricing will range between approximately US$736 and US$1,773 depending on risk classification and validity period.

At the same time, the Philippines FDA discussed implementation of the ASEAN MDD guidelines for device grouping.  This will significantly reduce the number of applications required to register families and systems of devices.  So even with the increase in individual application processing fees, overall application processing costs for many manufacturers will go down due to the reduced number of applications.

Initial registration evaluation fees are priced at PhP 13,500 per year with the option of 3-, or 5-year validity period.  Evaluation fees are payable at application submission after passings the pre-assessment stage. Then license renewal will be valid for 5 or 10 years.  License renewal applications can be submitted 90-days prior to license expiry, or up to 120 days after expiry with extra fees.

Proposed Medical Device Application Processing Fees

Per the draft Administrative Order, new medical device application and review fees are expected to be as follows: