January 10, 2020

The PFDA released the draft fees in preparation to the authority’s adaptation to the ASEAN Medical Device Directive (AMDD) risk-based classification. Table 1 illustrates the proposed updated PFDA fees for all relevant Medical device services of the PFDA.

It is important to note that the Legal Research Fee (LRF) will be added to the fees. The LRF is equivalent to 10.00 Philippine Pesos (For Fees less than Php 1,000) or 1% of the application fee. For example, the total fee of an initial Class A Notification will be computed as follows:

Php 15,000.00 + Php 150.00 (1% LRF) = Php 15,150.00

PFDA will receive comments from industry stakeholders on or before January 17, 2020.

Table 1. Proposed Fees for Medical Devices in the draft guidance released by the PFDA
 

References:
FDA Memorandum 2019-02, Draft of PFDA New Schedule of Fees

Tags:
Philippine Registration, PFDA Fees, Guidance Public Consultation