Costs to register medical devices in the Philippines are expected to a soar under new draft guidelines published by the Philippines Department of Health. The fees update, the first since 2001, is part of a top to bottom move to modernize medical regulations underway in the archipelago nation.
If adopted as expected later this summer, the new fee schedule will create four classes of medical devices in accordance with their safety risk, as determined by the Philippines Food and Drug Administration. At current rates of exchange, application fees would range from $93 for medical devices deemed to require little in the way of safety assessments to $560 for those considered highest risk. Evaluation fees would start at $18 and go up to $1,121. In addition, the government would charge an annual retention fee of between $37 and $244. Currently, Philippines regulatory fees total just about $140 per device for a five-year period.
The new fees are slated to go into effect in March or April 2019.