With the increasing Covid-19 cases in the country, there is also an increase in the demand of medical services including the use of mobile x-ray devices in the diagnosis of the disease. This prompted medical x-ray facilities to purchase mobile x-ray devices. But due to the delay in the delivery of the newly purchased mobile x-ray devices, suppliers provided service/loaner x-ray units for use until such time that the intended mobile x-ray devices are delivered to respective facilities. In response to pandemic, the Food and Drug Administration – Center for Device Regulation, Radiation, Health and Research (CDRRHR) thru the Radiation Regulation Division (RRD) shall be issuing a Special Permit for loaner unit mobile x-ray devices, intended for use in the diagnosis of Covid-19 patients in need of immediate imaging procedures and medical response.
The following requirements for special permit application shall be submitted:
- Letter of intent for the issuance of Special Permit addressed to:
ENGR. BAYANI C. SAN JUAN, MSc, MNSA, CESE Director IV
Center for Device Regulation Radiation Health and Research
- Duly accomplished medical x-ray license application form.
- Copy of On-Loan agreement between the user and the supplier.
- Copy of the Official Receipt or certificate of subscription of the personal dose monitor (TLD or OSL) from the provider of personnel dose monitoring service.
- Copy of the VALID Professional Regulation Commission (PRC) license of all the radiologic/xray technologist/s.
- Calibration certificate of the loaned mobile x-ray machine.
- Applicants may email the scanned copy of their documentary requirements to [email protected] or [email protected].
- The processing of Special Permit that will be used for Covid-19 outbreak is exempted from payment
- The effectivity of the Special Permit shall be upon the complete and correct submission of requirements.
- The validity of the Special Permit shall follow the duration of the use of equipment specified in the agreement.
- The use of loaned mobile x-ray machines shall adhere with the radiation protection and safety standards prescribed by FDA.
- In the event that the newly purchased mobile x-ray devices have been delivered and installed to respective facility, the facility shall submit an application for the issuance of appropriate authorization.
- Scanned copy of approved Special Permit shall be sent to the registered email of the facility.
This shall take effect starting 14 April 2020.
For your guidance.
Attachment:->FDA Advisory No.2020-744