The Food and Drug Administration (FDA) is currently developing the FDA eServices Portal System – an online platform for a streamlined License to Operate (LTO) application of FDA-regulated establishments.
In this regard, FDA is issuing this Advisory to inform all stakeholders that the application for eLTO for Medical Device Establishments within National Capital Region (NCR) is now on its pilot implementation. The eServices Portal is accessible through this link eservices.fda.gov.ph/, with the scope of the application is limited for the time being:
|FDA eServices Portal for LTO Application for Medical Device Establishments|
|Location of Establishment||National Capital Region (Metro Manila)|
|LTO Establishment Application||Distributor (Wholesaler, Importer, Exporter), and Trader of Medical Devices, in-vitro diagnostic device, reagents, equipment or devices used for treating sharps, pathological and infectious waste and water purification system|
|Type of LTO Application||Initial, Renewal, and Variation|
|Fees to be Paid||Based on current issuance on Fees and Charges (Reference: DOH Administrative Order No. 50 s. 2001)|
|Validity of Initial LTO||Two (2) years|
|Start of Pilot Implementation||23 November 2020|
|End of Pilot Implementation||07 December 2020|
For this Pilot Run, applications for Renewal and Variation in the LTO using the eServices Portal are only functional if the approved initial LTO is applied using the eServices Portal.
For those with existing LTO application via ePortal, you may opt to apply to the eServices Portal for a new fee. Previous payment will be forfeited as the application has already been processed.
The implementation of eServices Portal for Manufacturers, including Refurbishers of all health products shall be on November 2020.
Retailers of Medical Devices, Radiation Facilities and Installer of water treatment systems providing installation, repair and maintenance services to operators of water refilling stations and other users of water treatment systems shall be governed by separate rules and regulations.
Please follow Annex A of this Advisory for the Guideline and Checklist of Requirements, and Annex B for the Step-by-Step Guide in applying via eServices Portal and the procedure for checking of application status.