REGULATORY UPDATE | Guidelines for the Use of the Food and Drug Administration's e-Services Portal System for Retailers of Medical Devices Applying for Licenses to Operate (LTO)

FDA Circular No. 2022-007, which provides instructions on utilizing the FDA e-Services Portal System for the License to Operate (LTO) application of medical device retailers, was released by the Philippines FDA on September 9, 2022. This e-Services Portal System has been created and upgraded to offer a simplified online platform for FDA Authorization applications, including LTO applications for medical device retailers.

Cara Mendaftar untuk Lisensi untuk Beroperasi (LTO) bagi Retailer Alat Kesehatan

1. Access the Portal: Go to http://eservices.fda.gov.ph/ and click “Applications” in the upper right corner of the e-Services homepage.
2. Select Application Type: Click on "Business Establishment," then "Medical Devices," and choose "License to Operate (LTO)" for devices (Retailers). After that, click on "Initial Application."
3. Read Declaration: Before starting the application procedure, read the “Declaration and Undertaking.” Make sure the box is checked, then click “Start Application.”
4. Complete Application Form: Fill in the required information accurately according to the act of establishment. Ensure that the action or activity selected is correct before proceeding.
5. Product Line Details: Provide a list of product lines for medical devices along with brief descriptions. Click “Add Product Line” if there are multiple product lines.
6. Email Validation: Ensure the email address is valid and that the Authorized Representative has access to it. Note that all fields marked with an asterisk (*) are required.
7. GPS Coordinates: To find the actual location of the office address, click "Get GPS Coordinates" and place it on the map. The address listed in the SEC/DTI/CDA license must match the stated storage space address.
8. Qualified Personnel Information: Complete the information for qualified personnel and upload the required documents.
9. Self-Assessment Review: Use the "Self-Assessment Review" feature to verify the accuracy of the data and documents submitted.

Qualified Individuals for Resellers of Eye Lenses and Related Devices

Each branch or company must employ one optometrist in accordance with RA 8050, known as the "Revised Optometry Act of 1995," and one Qualified Person in accordance with AO 2020-0017. If the institution registers the same Ophthalmologist and Qualified Person during an FDA application, it is expected that the same individual will fulfill both roles.

During operating hours, both the Optometrist and the Qualified Person must always be available at their respective branches or agencies. They may operate in multiple optical shops or clinics, provided their schedules do not conflict.

According to Article V.B.2 of FC No. 2021-021, for optical shops selling eye lenses, prisms, contact lenses and their accessories, there must be one Qualified Person per branch or agency. Qualified Persons may include registered professionals or graduates from health-related courses such as Optometry, Medicine, Pharmacy, or other relevant fields.

Pre-Assessment Process

The submitted application and required documentation will be pre-assessed by an FDA assessor to ensure completeness and accuracy. Applications with incomplete or inaccurate information will not be accepted and will be terminated immediately.

Applications must be assessed within the business days and hours defined by the FDA. The FDA will notify applicants of the pre-assessment results via the email provided. If the application passes, the applicant will receive a Payment Order with a Reference Number, detailing the fees to be paid. If rejected, the FDA will inform the applicant of the reasons for denial and encourage them to reapply via the e-Services Portal.

Fee Payment

Total application fees must be paid using one of the following channels as indicated in the Order of Payment (OP):

• Landbank Over-the-Counter: Pay via https://bit.ly/36ChH4X using your FDA Clearing Account Number in accordance with FDA Memorandum Circular No. 2013-046.
• BANCNET Online: Payment can be made at https://bit.ly/3uB8PEL.
• Based on FDA Advisory No. 2021-0246, use the business portal Online Payment for LBP: https://bit.ly/3DmdPRv.

Application Approval

The application will be verified for accuracy and compliance with all applicable FDA rules and standards. An FDA acknowledgment receipt will be provided, containing the employee number/code who received the application, reference number, agency logo, date and time of application, payment details, and a statement of document completeness.

Once the applicant receives the Receipt of Acknowledgment, the application is considered submitted. If accepted, the FDA will send the LTO to the applicant's registered email address. If rejected, the FDA will notify the applicant of the reasons for refusal.

Application Disapproval

According to A.O. No. 2020-0017, applications may be rejected for the following reasons:

• Submitted documents do not meet necessary criteria.
• Failure to maintain a physical office during inspection.
• Incorrect or misleading entries.
• Violation of any licensing terms and conditions.
• Additional reasons as assessed by the FDA.

LTO Release

The LTO will be sent to the applicant's registered email address and can also be accessed via the FDA e-Services portal. Institutions are required to print the LTO on standard A4 paper (21 cm x 29.7 cm), in full color, and in portrait orientation immediately upon receipt. The LTO should be displayed prominently within the commercial building.

LTOs must include a QR Code verification as a legal basis. Any variations will be automatically reflected on the LTO. The applicant's registered email address will receive an updated LTO.

This FDA Circular will take effect fifteen (15) days after being published in widely distributed newspapers and submitted to the National Administration Registration Office of the University of the Philippines (UP-ONAR). Unless amended or cancelled, the rules outlined in this FDA Circular will remain in effect.

For inquiries regarding the registration of medical devices.