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Philippines FDA Guidance: License to Operate (LTO) Application of Retailers of Medical Devices

On 13 September 2022, the Philippines FDA released updated guidelines on the Use of the Food and Drug Administration eServices Portal System for License to Operate (LTO) Application of Retailers of Medical Devices.

This guideline describes the use of the FDA eServices Portal System for the LTO application of Retailers of Medical Devices and shall cover the following LTO applications:


A. Types of Establishments:

  1. Retail stores for medical devices;

  2. Clinics that sell products classified as medical devices except those that are covered by the DOH One Stop Shop Licensing System;

  3. Sellers of products classified as medical device through online shopping website and social media platforms with physical office;

  4. TV shopping companies that sell or offer to sell medical device directly to the general public;

  5. Optical shops;

  6. Drug outlets, such as drugstores, and retail outlets for non-prescription drugs (RONPD) that also sell or offer to sell medical devices.

B. Types of LTO application

  1. Initial;

  2. Renewal; and

  3. Variation

Click this LINK to see the circular about the Use of eServices Portal System for License to Operate (LTO) Application of Retailers of Medical Devices.


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