The FDA of the Philippines Updates the Regulation for Medical Devices and Pharmaceuticals with respect to Licenses to Operate (LTO)

In late 2024, the FDA of the Philippines outlined a new regulation for all companies importing, exporting, manufacturing, and selling medical products. This new Administrative Order is Order #2024-0015, an update from an older 2020 regulation. The new order covers all types of medical devices, including IVDs, devices that release radiation, custom-made devices, etc. Medical companies need to follow technical conformity assessment requirements and be open to facility audits by the Philippine FDA. Medical companies need to respond to LTO requests to improve their operations and processes so that they more closely align with local and international standards. Also, under the new regulation, the LTO validity timelines will be extended – for middle-sized medical companies, the LTO will now be valid for 6 years, for large-sized medical companies, the LTO will be valid for up to 12 years, and for small-sized medical companies, 3 years.

The LTO is critical in the Philippines because it is needed to get a Certificate of Product Registration (product approval) for all medical products from the FDA. If a company does not renew their LTO within 120 days of expiration, their LTO will be terminated by the FDA. To get an LTO, medical companies will need to provide a Registration Certificate from the Filipino SEC with the appropriate articles of incorporation, an audited financial statement, and the name of the quality person, which will vary depending on the type of medical business, among other requirements. To apply for an LTO, medical companies need to go to the Philippine FDA portal and open an account. Then, the applicant needs to fill out the appropriate application based on the medical business to be registered.

Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)