This month, the Center for Device Regulation, Radiological Health and Research (CDRRHR) has relocated from the Department of Health in Manila to new facilities within the FDA central compound in Alabang.
The change significantly involves medical device registration applications now being filed at the FDA Public Assistance, Information, and Receiving (PAIR) Unit as of July 19, 2016. As per their procedures, only electronic copies of applications and supporting documentation are now required.
These changes follow on the heels of a new, on-line notification procedure for updating the License to Operate to reflect new sources, a prerequisite to a new Certificate of Product Registration application.
To multinational manufacturers these changes should mean slightly faster market access for new devices as a result of more efficient processing of device registration and licensing applications.