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. The new registration fees will have three components that vary by risk classification as below:

Classification Type            Application   Evaluation Fee   Annual Retention fee

1.      Class A Notification              PhP 5,000         PhP 10,000             PhP  2,000

2.      Class B Registration            PhP 10,000       PhP 20,000             PhP  5,000

3.      Class C Registration            PhP 15,000       PhP 45,000             PhP  9,000

4.      Class D Registration            PhP 30,000       PhP 60,000             PhP 12,000

While not exorbitant by regional standards, the proposed changes do represent a significant increase in registration costs in the Philippines. Under the old Rules, government fees to process a Certificate of Product Registration (CPR) were PhP 1,500 for the initial application which was valid for 1 year and then PhP 5,000 for the renewal application which was valid for 5 years. By way of comparison, the 5-year regulatory fees for a CPR total about US$140, while the 5-year regulatory fees for a Class C Registration would total US$1,962.

A meeting was held to solicit stakeholder feedback on June 28th. Finalization of the guidance document on fees is expecting in the coming weeks.

Please contact Asia Actual with questions or support requests from our team in Manila.

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