Market Intelligence
Medical Devices

Philippine Medical Devices

On June 11, 2021, the Philippine Food and Drug Administration (FDA) released Administrative Order No. 2021-0038 or the “Framework for Philippine Essential Medical Devices List and Price Reference Index.” The Philippine Essential Medical Devices List (PEMDL) is a catalog of necessary medical devices for the preventive, therapeutic, diagnostic, or rehabilitative procedures done in Department of Health (DOH) hospitals and other DOH facilities.

This includes all government–owned and controlled corporations (GOCC), DOH special and specialty hospitals, medical centers, research hospitals, regional hospitals, district hospitals, extension hospitals, and sanitaria under the management and administration of DOH. This includes DOH offices and units, retained and corporate hospitals, treatment and rehabilitation centers, Centers of Health Development (CHD), and hospitals in the Bangsamoro Autonomous Region in Muslim Mindanao.

Currently, the catalog contains medical supplies, consumables, and other routinely procured items by the DOH. The catalog will include medical devices and medical equipment in its future reiterations. The catalog will then be updated quarterly, with comments or inputs to be reviewed and contained in the next quarter’s publication.

DOH facilities and entities may propose including medical devices in the PEMDL per the Health Technology Assessment guidelines under the Philippine Universal Health Care Law.

U.S. Medical device manufacturers, who are not yet present in the country, must work with a local distributor to ensure their products can be included in the PEMDL. The transitory period for implementing the PEMDL is from 2022 to 2025. After which, all medical devices will undergo the HTA General Track.

General information and other FAQs regarding the PEMDL can be found on this website: Philippine Essential Medical Device List (doh.gov.ph)

The U.S. Commercial Service can assist you in navigating the Philippine healthcare regulatory environment. Please contact Commercial Specialist Katrina Domingo at katrina.domingo@trade.gov.
 

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