Philippines Proposes New Fees for Medical Device Registration
Published on: July 11, 2018
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 Fee||Evaluation Fee||Annual Retention Fee|
|Class A Notification||PHP 5,000||PHP 10,000||PHP 2,000|
|Class B Registration||PHP 10,000||PHP 20,000||PHP 5,000|
|Class C Registration||PHP 15,000||PHP 45,000||PHP 9,000|
|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. Currently, registration fees follow guidance from the FDA’s Circular 2020-001.
A meeting was held to solicit stakeholder feedback on June 28th. Finalization of the guidance document on fees is expecting in the coming weeks.
To learn more about the current registration process fees and timelines, click here for an overview and contact us for more detailed information.
Please contact Asia Actual with questions or support requests from our team in Manila to help you navigate the new fees proposed by the Philippines.