“Even as individual application fees go up, overall regulatory costs will decrease for many manufacturers as the grouping guidelines will significatly reduce the number of appilcations required in the Philippines.”
Charmaine Roson
Principal Consultant
Asia Actual Philippines
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Philippines FDA Announces New Fee Schedule for Medical Devices
Published on: December 15th, 2023
On November 29th 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:
| Medical Device Classification | Pre-Assessment Fee | Evaluation Fee (3 Year Validity) | Evaluation Fee (5 Year Validity) |
|---|---|---|---|
| Class A Notification (CMDN) | PhP 500 (~US$9.10) | PhP 40,500 (PhP 13,500 x3) (~US$736) | PhP 67,500 (PhP 13,500 x5) (~US$1,227) |
| Class B Registration (CMDR) | PhP 500 (~US$9.10) | PhP 54,000 (PhP 18,000 x3) (~US$982) | PhP 90,000 (PhP 18,000 x5) (~US$1,636) |
| Class C Registration (CMDR) | PhP 500 (~US$9.10) | PhP 54,000 (PhP 18,000 x3) (~US$982) | PhP 92,500 (PhP 18,500 x5) (~US$1,682) |
| Class D Registration (CMDR) | PhP 500 (~US$9.10) | PhP 58,500 (PhP 19,500 x3) (~US$1,055) | PhP 97,500 (PhP 19,500 x5) (~US$1,773) |
(US$1 = PhP 55)
Proposed Diagnostic Device Application Processing Fees
Application processing fees for IVD devices by risk classification are included in the Administrative Order‘s Annex C in anticipation of new IVD Rules expected early next year.
| Diagnostic Device Classification | Pre-Assessment Fee | Evaluation Fee (3 Year Validity) | Evaluation Fee (5 Year Validity) |
|---|---|---|---|
| Class A Notification (CMDN) | PhP 500 (~US$9.10) | PhP 43,500 (PhP 14,500 x3) (~US$791) | PhP 72,500 (PhP 14,500 x5) (~US$1,318) |
| Class B Registration (CMDR) | PhP 500 (~US$9.10) | PhP 58,200 (PhP 19,400 x3) (~US$1,058) | PhP 97,000 (PhP 19,400 x5) (~US$1,764) |
| Class C Registration (CMDR) | PhP 500 (~US$9.10) | PhP 60,000 (PhP 20,000 x3) (~US$1,091) | PhP 100,000 (PhP 20,000 x5) (~US$1,818) |
| Class D Registration (CMDR) | PhP 500 (~US$9.10) | PhP 61,200 (PhP 20,400 x3) (~US$1,113) | PhP 102,000 (PhP 20,400 x5) (~US$1,855) |
(US$1 = PhP 55)
New fee schedules for the registration of pharmaceuticals, cosmetics, and food supplements were also covered at the meetings and included in the draft documents.
Implementation Timelines
The draft Administrative Order is expected to be finalized and published in March of 2024 and come into full effect in July or August of 2024.
Participants were reminded of the application holiday for new submissions from Dec 15, 2023 to Jan 15, 2024 in place to help clear any application backlog.
Finally, the Philippines FDA expressed its commitment to improve on application processing upon implementation of the new fees.
Grow With Us
Please contact us if you have questions regarding the draft guidance or are interested in registering your product in the Philippines.
Asia Actual is a regulatory consulting company focused on helping manufacturers grow sales in challenging Asia markets through independent license holding, direct fulfillment, and a variety of sales channel support services.
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