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 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 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.

4 PRODUCT DEVELOPMENT DECISIONS THAT IMPACT SALES PERFORMANCE IN ASIA

US medical device manufacturers typically launch new products in Asia only after establishing success in the US and Europe. However, decisions made in the product development process have significant impact on regulatory costs, time to market and ultimately sales results in Asia. Address these four points to ensure fastest time-to-revenue in Asian markets.

NEW OFFICE SPACE FOR ASIA ACTUAL PHILIPPINES

Asia Actual is excited to announce the dedication of our new office space in the Philippines. The investment reflects the company’s commitment to the Philippines market and expectations for growth.