On November 27, 2024, the Philippine Food and Drug Administration (FDA) released Administrative Order No. 2024-0015, introducing updated regulations on the License to Operate (LTO) requirements for health product establishments. This includes rules for initial applications, renewals, and variations, applicable to medical device distributors (importers, exporters, wholesalers), manufacturers (including packers, repackers, refurbishers, and traders), and other related entities.
Key Updates in the Regulation
1. Mandatory LTO for Manufacturers of Specific Medical Devices:
- Establishments involved in the following activities must secure an LTO as a Manufacturer:
- 3D printing of medical devices
- Optical establishments assembling lenses and frames
- Dental laboratories manufacturing custom-made dental devices
2. LTO Validity Period by Enterprise Size:
The validity of an LTO depends on the type of enterprise, as follows:
| LTO Type | Micro and Small Enterprises | Medium and Large Enterprises |
|---|---|---|
| Initial LTO | 3 Years | 6 Years |
| Renewal LTO | 6 Years | 12 Years |
3. Application Submission via eServices:
All initial, renewal, and variation applications must be submitted through the eServices Portal System. Establishments are required to use a single official email address for communication to prevent miscommunication.
4. Inspection Authority:
The FDA reserves the right to inspect any covered facility. Inspections may include pre-licensing, routine, or other types as deemed necessary and may occur on-site or in hybrid formats. Inspectors can obtain copies of relevant documents during these inspections.
5. Renewal Deadlines and Surcharges:
- Renewal applications must be submitted at least 90 days before the LTO expiration date.
- Applications submitted after expiration will incur surcharges based on the following formula:
Surcharge/Penalty = 2 x (Renewal Licensing Fee) + 10% (Renewal Licensing Fee per Month).
The surcharge increases by 10% each month after the expiration date, as outlined below:
The surcharge increases by 10% each month after the expiration date, as outlined below:
| Submission Period | Surcharge Calculation Example |
|---|---|
| 1st month after expiration | 2 x Php2,000 + Php200 = Php4,200 |
| 2nd month after expiration | 2 x Php2,000 + Php400 = Php4,400 |
| 3rd month after expiration | 2 x Php2,000 + Php600 = Php4,600 |
| 4th month after expiration | 2 x Php2,000 + Php800 = Php4,800 |
Next Steps for Stakeholders
If you are a covered establishment, ensure compliance with the new regulations by:
- Reviewing the specific requirements outlined in Administrative Order No. 2024-0015.
- Submitting applications through the FDA eServices Portal System using a single official email address.
- Scheduling renewals within the prescribed timelines to avoid penalties.
Additional Information
For more details on the regulation, access the official Administrative Order through the link below:
Administrative Order No. 2024-0015 – FDA PhilippinesShould you have any inquiries or require further assistance, please do not hesitate to contact us at sales@andamanmed.com or click the button below.