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Guidelines on the Use of the Food and Drug Administration e-Services Portal System for License to Operate (LTO) Application of Retailers of Medical Devices

On September 9, 2022, the Philippines FDA issued FDA Circular No 2022-007 that provides guidelines on the use of the FDA e-Services Portal System for the LTO Application of Medical Device Retailers. The FDA e-Services Portal System has been developed and updated to provide a streamlined online platform for FDA Authorization applications to include LTO applications for Medical Device Retailers. The following is the summary of the guidelines: The FDA Circular shall cover the following:
Type of Establishments Type of LTO Applications
  1. Retail stores
  2. Clinics except those that are covered by the DOH OSS Licensing System
  3. Sellers e through online shopping website and social media platforms with physical office
  4. TV shopping companies that sell or offer directly to the general public
  5. Optical shops
  6. Drug outlets and RONPD that also sell or offer to sell medical devices
  1. Initial
  2. Renewal
  3. Variation

Application Process/ Guidelines

  1. Applications shall be filed through the e-Services Portal (eservices.fda.gov.ph)
  2. For the procedure of initial, renewal, variation, and checking of application status, please refer to ANNEX A, B, C, and D
  3. Declared email address is unalterable. For any changes to the declared email, send an email request addressed to the FDA – Food and Drug Action Center at pacd@fda.gov.ph)
  4. Variation and renewal applications shall be applied separately
  5. The LTO applied through FDA e-Services Portal System shall have a change in the format of LTO number as such:
    • Old: 3000000XXXXXX
    • New: CDRRHR-(Region)-(Activity)-(Sequence Number)
  6. File size shall not be more than 2MB
  7. Application summary shall be sent to the registered email once submitted
  8. Applications filed after prescribed working/office hours or during weekends and holidays shall e considered filed on the next working day.
  9. Application requirements are stated in AO 2020-0017
 

Qualified Person for Retailers of Ophthalmic Lenses and Similar Devices

  1. An optical shop shall have 1 optometrist based on RA 8050 and 1 qualified person based on AO 2020-017
  2. The optometrist and qualified person per branch/establishment shall always be available during operating hours. They may operate or work in more than 1 optical shop/clinic provided that their schedules shall not overlap with other branches
  3. Section V.B.2 of FC No. 2021-021 is amended as follows:
    < /br> For Optical Shop that retail ophthalmic lenses, prisms, contact lenses, and their accessories and solutions, low vision aids, and similar appliances and devices, wherein dispensing is governed by RA 8050 otherwise known as the “Revised Optometry Law of 1995”, there shall be one (1) Qualified Person per branch/establishment. The Qualified Person can be a registered professional or graduate of allied health course including but not limited to Optometry, Doctor of Medicine, Pharmacy or other courses relevant to the medical devices being handled.

Pre-Assessment

  • If the application passed the pre-assessment step, an Order of Payment shall be sent to the registered email of the applicant.
  • If the application didn’t pass the pre-assessment step, the FDA shall notify the reasons for non-acceptance listing the deficiency found and will prompt the apply to again through the eService Portal.

Payment Method

Approval of Application

  • If the application is approved, the LTO shall be send to the registered email address of the applicant.

  • Grounds for Disapproval of Application

    • Documents submitted does not meet appropriate standards
    • Absence of physical office upon inspection
    • Misrepresentations/ false entries
    • Violation of any terms and conditions of its license
    • Other grounds determined by the FDA

    Release of LTO

    • The LTO shall be sent to the registered email
    • Establishments must print it on standard A4 size (21 cm x 29.7 cm) paper, on full-colored page and in portrait orientation
    • LTO must be placed on the most conspicuous place
    • QR code vierifier shall be included in the LTO as basis of legitimacy of the document
    • Variations will be automatically reflected on the LTO. An updated LTO will be provided to the registered email address of the applicant

    Effectivity

    • Takes effect 15 days following its publication in a newspaper of general circulation and upon filing with the University of the Philippines Office of the National Administrative Register (UP-ONAR).
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