National Telecommunications Commission (NTC) Rules and Regulations for Medical Devices with Wireless Data Networks

2018-10-24T14:42:00+08:00 May 29th, 2018|News & Events|

The National Telecommunications Commission of the Philippines issues permits and certificates to importers of indoor equipment and devices that require Wireless Data Networks (WDN) or are WIFI-enabled/Bluetooth medical devices.

Background
The National Telecommunications Commission (NTC) is responsible for the supervision, adjudication, and control of all telecommunication services in the Philippines. The NTC works closely with the Department of Science & Technology, Advanced Simulation Technology Inc., and the Department of Information Science & Telecommunication.

Regulated Equipment under the NTC:
Radio Communication Equipment (RCE) are devices capable of emitting radio frequency waves or energy intended for the transmission of signals, messages or intelligence with the use or support of WI-FI/Bluetooth devices.

Customer Premises Equipment (CPE) is defined as equipment located in the premises of a customer or subscriber, for connection to public telecommunications network facilities.

The above listed regulated equipment is governed under Section 1A of the Republic Act No. 3846 as amended and the Department Order No. 11, for issuance of permits to purchase, possess or construct, sell or transfer or operate RCE devices; the Memorandum Circular No. 1-04-88 for CPE devices; and, the Memorandum Circular No. 2-05-88, for the manufacture, acquisition, sale, and service of these regulated devices.

Permits Issued by the NTC:
The below listed permits and certificates are issued by the NTC to importers of indoor equipment and devices that require Wireless Data Networks (WDN) or are WIFI-enabled/Bluetooth medical devices:

  • Import Permit – issued by the National Single Window, and the application should be supported by a proforma invoice, information on the type/model of the device, and the number of units to be imported
  • Release Clearance – imported equipment and devices shall, upon release from the Bureau of Customs, submit a monthly summary of sales and a stock report to the Commission
  • Type Approval/Acceptance Registration – all regulated equipment/devices shall be submitted by the accredited dealers and suppliers to the Equipment Standards Division for a type approval/acceptance registration. Registered indoor equipment issued by the Commission must bear an NTC registration number for identification purposes.

The following documents are necessary for submission:

  • Application Form
  • Letter of Authorization
  • R&TTE or FCC Test Report or RF Module Report
  • Safety and EMC Test Report
  • Technical Specifications
  • User Manual (English)

Administrative Sanctions:
Violations of any of the provisions of the circular are dealt with in accordance with the existing rules and regulations and may include the cancellation of registration, accreditation, authorization, permits, and licenses. Appropriate fines and other administrative sanctions may also be imposed.

Source:
National Telecommunications Commission (Official Website)
Wireless Data Networks and Devices