The Philippines Department of Health is now requiring that most medical devices imported, marketed or manufactured in the archipelago nation be registered with its Food and Drug Administration.
The new rules, first telegraphed back in January, are expected to increase costs for medical device manufacturers doing business in the country. Under the rules, medical devices will be subject to four classes of registration and notification requirements and fees in accordance with their safety risk, as determined by the Philippines FDA. Previously, not all medical devices required registration.
Devices deemed to be low risk will only require notification. But those deemed low to moderate, moderate to high and high risk will need to be registered, and will be charged a range of fees, slated to go into effect without exception in April, 2019.