Charmaine Roson - Philippines

“The first version of the PEMDL will be based on the World Health Organization’s (WHO) technical specifications.”

Charmaine Roson
Principal Consultant
Asia Actual Philippines

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Philippines Announces New PEMDL Essential Medical Device List

Published on: June 30th, 2021

Notification AO 2021-0038 was released on June 11th, 2021 with the goal of creating a standardized system for determining and maintaining a database of essential medical devices, hereby known as the Philippine Essential Medical Device List (PEMDL). Additionally, the Medical Devices and Supplies Price Reference Index (MDSPRI) will also be established to provide more price transparency when it comes to medical devices in the Philippines.

Philippine Essential Medical Device List (PEMDL)

The PEMDL is defined as “the list of medical devices considered as important or necessary for preventive, diagnostic, therapeutic, or rehabilitative procedures carried out in government health facilities.” Its purpose is to provide procurement guidance, price transparency, and price consolidation for essential medical devices. The PEMDL will include the technical specification (TS), which will be determined by the Health Technology Assessment Council (HTAC). The first version of the PEMDL will be based on the World Health Organization’s (WHO) technical specifications and from the latest purchase orders of the end-users, defined as “all DOH Offices/Bureaus, Centers for Development (CHDs) and all healthcare facilities under the DOH procuring and/or utilizing medical devices, supplies, and equipment.” Any new medical devices wishing to be added to the list will need a Health Technology Assessment (HTA).

Medical Devices and Supplies Price Reference Index (MDSPRI)

Furthermore, this Notification also establishes the Medical Devices and Supplies Price Reference Index (MDSPRI), which will provide recommended pricing for medical devices used by DOH health facilities. The Medical Device Unit (MDU) will oversee the determination of prices, which will be calculated every year based on prevailing procurement prices of medical devices. It is important to note that the MDSPRI shall be the maximum procurement price for essential medical devices.

Future Updates for PEMDL and MDSPRI

The PEMDL and MDSPRI will be updated annually by the MDU, and changes will be viewable through website posts and/or distribution of booklets to all government health facilities. A Manual of Operation (MOP) will provide more details on the PEMDL. It will be available on the DOH and PD websites. The effective date of this notification is within 15 days after its publication in a newspaper and upon filing with the University of the Philippines Law Center of 3 certified copies of this notification.

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Asia Actual specializes in helping medical device manufacturers grow their sales in Asia with experienced, bi-lingual commercial and regulatory experts on the ground in each market. Contact Asia Actual today to see how new regulatory developments may affect your business in the Philippines.

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