PHILIPPINES OFFICIALLY LAUNCHES NEW MEDICAL DEVICE REGULATIONS
New medical device regulations in the Phillipines have been launched. Class A, Class B, Class C, and Class D medical devices will all be affected.
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New medical device regulations in the Phillipines have been launched. Class A, Class B, Class C, and Class D medical devices will all be affected.
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.
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.
The 8th ASEAN Medical Device Committee Meeting (AMDN) will take place in Manila from August 4-8, 2019.
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.
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.
On December 15, 2017 the FDA released guidance that provides for streamlining of the submission process for CPR amendments.