ABSTRACT

The Philippines has a population annual growth rate of 1.72% per year with a life expectancy of 72 years. The medical device products are mostly imported, and 100% of medical equipment is imported. Local production limited to supplies such as masks, gloves, cotton, tube sets, and elastic bandage. The current demand for medical devices is based on the growing incidences of various diseases. The Food and Drug Administration of the Philippines is mandated to safeguard the health of the people. The Center for Device Regulation, Radiation Health and Research (CDRRHR) is one of the Centers that is established to regulate medical devices, health-related devices, ionizing and non-ionizing radiation facilities. Distributors include the importers, exporters, wholesalers, and retailers while manufacturers include the manufacturer, re-packers and traders. The filing of application for notification is done online through the e-portal system.