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Republic of the Philippines

Department of Health

Food and Drug Administration

CENTER FOR DEVICE REGULATION,

RADIATION HEALTH, AND RESEARCH

CHECKLIST FOR RENEWAL / ISSUANCE OF A LICENSE TO OPERATE (LTO)

A NON-MEDICAL X-RAY FACILITY

Duly accomplished non-medical x-ray license application form (2 copies).

License application fee (refer to the schedule of fees below). For mailed applications, Postal Money

Order or Manager’s Check shall be payable to the FOOD AND DRUG ADMINISTRATION.

(PMO Address: Alabang, Muntinlupa City)

Photocopy of the Official Receipt of the personal dose monitor (TLD or OSL) from the provider of

personnel dose monitoring service. (FOR RENEWAL APPLICATION ONLY)

Photocopy of the personal dose evaluation reports within the validity period of the previous license

(FOR RENEWAL APPLICATION ONLY)

Photocopy of certificate of training of the radiation protection officer (RPO) in an appropriate

Radiation Protection for Radiation Safety Officers training course conducted by an organization

recognized by the CDRRHR.

Provision of Radiation Survey Meter. Applicant must be able to provide adequate access to a

radiation monitoring instrument, for the conduct of the appropriate regular workplace monitoring.

Photocopy of valid Radiation Survey Meter Calibration Certificate. The radiation monitoring

instrument should be calibrated at least once a year.

Copy of periodic workplace area monitoring results within the validity period of the expired license

(for renewal applicants only).

Duly filled-up and notarized affidavit of continuous compliance (FOR RENEWAL

APPLICATION ONLY).

Photocopy of the business/mayor’s permit or SEC/DTI registration of the facility (FOR INITIAL

10.

APPLICANTS AND RENEWAL APPLICANTS WITH NEW ADDRESS).

11. Photocopy of the latest License to Operate. (FOR RENEWAL APPLICATION ONLY).

Schedule of Fees (per x-ray machine)

Renewal of Expired LTO

RENEWAL

mA RANGE

INITIAL

(Valid LTO)

Month

> 4 months

100 and below

810.00

410.00

1,250.00

1,290.00

1,330.00

1,370.00

1,770.00

101 up to 300

1,111.00

560.00

1,715.00

1,770.00

1,825.00

1,880.00

2,431.00

301 up to 500

1,414.00

710.00

2,180.00

2,250.00

2,320.00

2,390.00

3,094.00

501 up to 700

1,717.00

860.00

2,645.00

2,730.00

2,815.00

2,900.00

3,757.00

greater than 700

2,020.00

1,010.00

3,110.00

3,210.00

3,310.00

3,410.00

4,420.00

Notes:

The surcharge/penalty for late filing of the renewal of LTO will be assessed pursuant to the Implementing Rules and Regulations

(Book II, Article I Section 3.A.2) of RA 9711 and to the FDA Circular No. 2011-004 as follows:

“An application for renewal of an LTO received after its date of expiration shall be subject to a surcharge or penalty equivalent

to twice the renewal licensing fee and an additional 10% per month or a fraction thereof of continuing non-submission of such

application up to a maximum of one hundred twenty (120) days. Any application for renewal of license filed thereafter shall be

considered expired and the application shall be subject to a fee equivalent to the total surcharge or penalty plus the initial filing fee

and the application shall undergo the initial filing and evaluation procedure.”

Pursuant to FDA Circular No. 2011-003, a Legal Research Fee (LRF) amounting to “one percent (1%) of the filing fee imposed, but

in no case lower than ten pesos” shall be collected.

Incomplete requirements shall not be processed.

For initial/renewal application, fee paid shall be forfeited when the facility fails to comply with the licensing requirements within 60

days upon proper notice from the CDRRHR. (Section 5 item no. 2 of the Bureau Order No. 005 s. 2005)

_______________________________________________________________________________________________

Building 24, San Lazaro Compound, Rizal Avenue, Sta. Cruz, 1003 Manila

Telefax Nos. (632)711-60-16, Trunk Line: (632)651-78-00 local 3401 to 05, 3408 to 12

URL: e-mail: apperalta@co.doh.gov.ph

Form Qwp-Cdrrhr-4-01-Annex 2.3 - Application Form For A License To Operate A Non-Medical X-Ray Facility

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