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 offers instructions on how to utilize the FDA e-Services Portal System for the LTO Application of Medical Device Retailers, was released by the Philippines FDA on September 9, 2022. To provide a simplified online platform for FDA Authorization applications, including LTO applications for Medical Device Retailers, the FDA e-Services Portal System has been created and upgraded.

How to register for License to Operate (LTO) for Medical Device Retailers using the e-Service portal system Retailer Alat Kesehatan menggunakan sistem e-Service portal

• Go to http://eservices.fda.gov.ph/ to access the web portal, then click “Applications” in the upper right corner of the eServices homepage
• Click on Business Establishment, Medical Devices, and License to Operate (LTO) options for devices (Retailers) and click Initial Application.
• Before starting the application procedure, please read “Declaration and Undertaking.” Make sure the box is checked, then click “Start Application.”
• Fill in the required information correctly and thoroughly in accordance with the act of establishment. Before proceeding to the following steps, make sure the action or activity being checked is correct.
• List of product lines for medical devices along with a brief description. Click “Add Product Line” if there are two or more product lines.
• The applicant must ensure that the email address is valid and that the Authorized Representative has access to the address please note that all fields marked with an asterisk (*) are required.
• To find the actual position of the office address, click "Get GPS Coordinates". Place it right on the map.
• Address listed in the SEC/DTI/CDA license must match the stated storage space address. Otherwise, the stated address must match the address stated on the business license.
• If more than one address storage space is provided, each GPS address coordinate created on the Geo-Coding Map must be indicated in the application.
• The party who is trusted as the person using the name declared by the FDA and exclusively has the rights to the business name.
• Complete the information of qualified personnel. Upload the required documents.
• "Self-Assessment Review" allows the applicant to view all specifications of the application applicant must verify the accuracy of the data and documents submitted

Qualified Individuals for Reseller of Eye Lenses and Related Devices

• Each branch/company must have oneOptometrist in accordance with RA 8050, also known as the "Revised Optometry Act 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 person will act on both duties as described in this order.
• During operating hours, Optometrist and Qualified Person Per branch/agencies must always be available. They can operate or work in more than 1 optical shop/clinic as long as their schedule does not conflict with the operating hours of each branch/other agency.
• Article V.B.2 FC No. 2021-021 is hereby amended to read as follows: For Optical Shops selling eye lenses, prisms, contact lenses and their accessories and solutions, low vision aids, and similar equipment and devices, where expenditure is regulated by RA 8050 otherwise known as "Revision of the Optometry Law of 1995", there must be 1 Qualified Person per branch/agency. Qualified Persons may be registered professionals or graduates of health related courses including but not limited to Optometry, Doctor of Medicine, Pharmacy or other courses relevant to the medical device being treated.

Pre-assessment

The submitted application and required documentation will be pre-assessed by an FDA assessor to determine whether the application is accurate and complete. Applications that include incomplete or inaccurate data entry or document submissions will not be accepted, and applications will be terminated immediately.

Applications must be assessed in advance within FDA-defined business days and hours. The FDA must notify the applicant of the results of the pre-assessment via the email address provided on file. The applicant will receive a Payment Order with Reference Number by email, which will include the fees to be paid if the application passes the pre-assessment stage. However, if the application fails in the pre-assessment stage, the FDA must notify the applicant of the reasons for rejection, such as deficiencies found, and encourage them to reapply via the eServices Portal. eServices.

Fee Payment

Payment of the total application fee must be made in one of these payment channels, as indicated in the Order Of Payment (OP):

• Via this URL, https://bit.ly/36ChH4X, you can pay Landbank Over-the-Counter using your FDA Clearing Account Number in accordance with FDA Memorandum Circular No. 2013-046.
• BANCNET online (https://bit.ly/3uB8PEL)
• Online payment link for LBP. Based on FDA Advisory No. 2021-0246, business portal (https://bit.ly/3DmdPRv)

Application Approval

Required to verify application accuracy and compliance with all applicable FDA rules and standards.

An FDA acknowledgment receipt, containing the employee number/code who received the application, reference number, agency logo, date and time of application, payment, and a statement of completeness of documents submitted, will be provided to the application with all required documentation and payment.

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

Application Disapproval

To emphasize, A.O. No. 2020-0017 states that any of the following reasons may be used to reject the KPP application:

• Dokumen yang diberikan tidak memenuhi kriteria yang diperlukan
• Kegagalan untuk memiliki kantor fisik pada saat inspeksi
• Entri yang salah atau menyesatkan
• Pelanggaran syarat dan ketentuan lisensi apa pun
• Alasan tambahan seperti yang dinilai oleh FDA

LTO release

LTO will be sent to the applicant's registered email address, and they can also get it via FDA eServices portal. Institutions are required to print the LTO on standard A4 paper (21 cm x 29.7 cm), on full color pages, and in portrait orientation immediately upon receipt. It should be placed in the most obvious place in the commercial building.

LTOs must have a QR Code verification as a legal basis. Variations applied to a variation should automatically appear in LTO. Applicant's registered email address must obtain an updated LTO.

After being published in newspapers with wide distribution and submitted to the National Administration Registration Office of the University of the Philippines, this FDA Circular shall be effective fifteen (15) days later (UP-ONAR). Unless amended or cancelled, the rules outlined in this FDA Circular will remain in effect.

Contact us if you want to inquire about registration of medical devices. Contact Us