The Philippines Food and Drug Administration on April 11 will begin implementing new rules that require registration of most medical devices imported, marketed or manufactured in the archipelago nation.
The rules, in the works for more than a year, are expected to increase costs for medical device manufacturers doing business in the country. The rules establish four classes of registration for medical devices and include notification requirements and fees in accordance with safety risk, as determined by the Philippines FDA. Previously, not all medical devices required registration.
Initially, just those devices categorized as Class A will be subject to the new rules. Implementation dates for Class B, C and D devices have not been set. The grace period for compliance with the new rules is expected to be set at one year.