Medical devices that incorporate wireless technology, such as cellular, RFID, WiFi, or Bluetooth, in the Philippines are considered Radio Communication Equipment (RCE) and subject to regulatory requirements of the National Telecommunications Commission (NTC). Each product must obtain a Device Type Approval (DTA) certificate, and each imported consignment must obtain an Import Permit.
DTA Certificates and Import Permits are issued to a local, licensed company with a valid Dealers Permit issued by the NTC. This entity will be responsible for submitting applications, customs clearance facilitation and monthly sales reporting in the form of Sales & Stock Report (SSR) complete with Professional Electronics Engineer (PECE) signal and seal.
It should be noted that compliance to these wireless technology registration requirements applies even if the host medical device is currently exempted for registration with the Philippines FDA (e.g., non-Notified medical devices).
Timelines and Fees
Applications are typically processed within 30 working days from the date of submission. Queries may be received for incomplete documents extending lead time.
The Philippines National Telecommunications Commission charges two fees for the service:
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