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)

PHILIPPINES DELAYS LAUNCH OF NEW MEDICAL DEVICE REGULATIONS

The Philippines Food and Drug Administration (FDA) intended to implement the first two phases of the new medical device regulatory system (known as Administrative Order 2018-0002) on April 11, 2019, however the implementation date has been delayed.  Extra time is needed for the CDRRHR to finalized guidelines for classification and grouping, etc.

PHILIPPINES TO HOST ASEAN MEDICAL DEVICE COMMITTEE MEETING / TRAINING

The 8th ASEAN Medical Device Committee Meeting (AMDN) will take place in Manila from August 4-8, 2019.