Philippines Announces New PEMDL Essential Medical Device List

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.

COVID Test Kits Now Require In-Country Testing in the Philippines and Indonesia

At this time Indonesia’s Ministry of Health will only regulation Rapid Diagnostic Tests (RDTs) while the Philippines Department of Health will require testing for RDTs, along with other related products such as Nucleic Acid Extraction Kits and COVID-19 antibody tests. It’s expected that the process will require 1-2 months in each country.

Sales Target Spotlight: Philippines’ St. Luke’s Medical Center

St. Luke’s Medical Center (SLMC) in both Quezon City and Taiguig/Global City are top-tier hospitals with Joint Commission International (JCI) accreditation that operate at the quality of international standards. The use of novel technologies for procedures such as 2D and 3D breast ultrasound, laser dermatology procedures, robotic assisted urological surgeries, etc. make SLMC a great target for innovative medical device manufacturers.

Philippines FDA Announces New Requirement for All Medical Devices

On January 4th, the Philippines FDA released FDA Circular 2021-002. This Circular outlines new requirements for previously exempted medical devices, amending the previous transition plan. All remaining Class B, C, and D devices not listed in the updated Annex will now need to apply under the Notification route currently used for Class A devices.

Philippines FDA Alters Requirements for Radiation Licensing During COVID-19

FDA’s Circular No. 2020-035 will take into effect immediately, and will pertain to the conduct of licensing inspection for radiation facilities in particular.

Philippines Releases US$9M To Hospitals For COVID-19 Response

The PCSO is a major source of funding for new hospital construction and medical device and equipment purchases and is often overlooked by outside suppliers. Medical device manufacturers should discuss with their Philippines distributors about what opportunities are available through the PCSO.

Philippines Proposes New Fees for Medical Device Registration

The Philippines Department of Health published a draft schedule of fees to be charged for medical device registrations under the new Rules next year. As per Administrative Order 2018-0002, medical devices will be classified by increasing risk from A to D. 

PHILIPPINES TO BAN POWDERED SURGICAL AND EXAM GLOVES

With FDA Advisory No. 2017-180 issued on June 20, 2017 the Philippines Food and Drug Administration (FDA) announced intentions to gradually switch to power-free gloves.  A full ban of powdered surgical and examination glove will go into effect on January 1, 2019 effecting the importation, distribution and sale of specified devices.

Philippines Implements New Customs Clearance Procedure for Radiation Devices

Radiation-emitting medical devices such as X-ray machines, MRIs, linear accelerators and ultrasound scanners are now subject to a new customs clearance release procedure administered by the Philippine Food and Drug Administration (FDA)