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  1. www.fda.gov.ph › fda-circular-no-2021-0021-guidelines-on-theFDA Circular No.2021-0021 || Guidelines on the Licensing of...

    Furthermore, pursuant to the provisions of the same law, a License to Operate (LTO) is required for establishments engaged in the sale, offering for sale or retail of any medical device including in-vitro diagnostic device.

  2. www.fda.gov.ph › 2019 › 09DISTRIBUTOR/IMPORTER/EXPORTER - Food and Drug Administration

    OBJECTIVES. To ensure that all concerned stakeholders understand the process for the application of a license to operate and the regulatory requirements during operations. To ensure the quality and identity of products during all aspects of the distribution process.

  3. www.dayananconsulting.com › how-to-apply-for-fda-lto-licenseHow to Apply for FDA LTO (License to Operate) in the Philippines

    Jan 13, 2020 · Steps for FDA LTO Application. Tips to make application easier and faster. What is an LTO or License to Operate? Why would you need one? An LTO allows you to legally import, distribute, sell wholesale, and/or manufacture food, drugs, cosmetics, and medical devices.

  4. asiaactual.com › blog › the-philippines-fda-issues-guidanceThe Philippines FDA Issues Guidance for Retailers of Medical...

    Oct 15, 2021 · The new regulations apply to establishments that provide medical devices Direct to Consumers (DTC) including pharmacies and eCommerce storefronts. These establishments will now need to apply for a License to Operate (LTO) and staff a qualified person in accordance with AO No. 2020-0017.

  5. eservices.fda.gov.ph › faqsFDA eServices Portal

    The FDA eServices Portal System is an online application system for obtaining FDA market authorizations, such as License to Operate (LTO) for retailers of drugs and medical devices, distributors and traders of processed foods, drugs, medical and health-related devices.

  6. ndvlaw.com › e-portal-filing-and-application-for-a-license-toE-Portal: Filing and Application for a License to Operate (LTO)...

    As provided in the Guidelines, the following are the documentary requirements in applying for a License to Operate as a Cosmetics/Drug /Medical Device / Food Manufacturer, Importer, or Distributor. Accomplished Application Form and Declaration and Undertaking

  7. www.regulatoryaffairsnews.com › post › philippines-fdaPhilippines FDA: Guidelines on the Licensing of Retailers of...

    Oct 13, 2021 · This guide aims to: A. Specify the establishments classified as retailers of medical devices; B. Clarify the licensing of drug outlets which are also retailers of medical devices; C. Provide specific requirements for and responsibilities of qualified persons of retailers of medical devices; and.