Rules and Regulations on the Licensing of Radiation Facilities and Issuance of Other Related Authorizations

I. RATIONALE

In 1974, Presidential Decree (PD) No. 480 created a national regulatory agency known as the Radiation Health Office (RHO) in the Department of Health (DOH) whose major function was to safeguard and promote people’s health and to institute proper measure for the effective control of both ionizing and non-ionizing radiation hazards emitted from electrical and electronic devices used in medical and non-medical application. In 1978, PD 1372 was issued to strengthen the DOH agency expanding the functions of the RHO which later became the Radiation Health Service (RHS). In 1999, Executive Order No. 102, was issued redirecting the functions and operations of the DOH, and the RHS was renamed the Bureau of Health Devices and Technology (BHDT). In 2009, Republic Act (RA) No. 9711 known as the “Food and Drug Administration (FDA) Act of 2009” was enacted into law, and the “The Rules and Regulations Implementing Republic Act No. 9711 - The Food and Drug Administration Act of 2009” was also issued to enhance the regulatory capacity and strengthen the capability of both the Bureau of Food and Drug and the BHDT with regard to the regulation of facilities and establishments, and the registration and monitoring of products and establishments. Since then, the BHDT was renamed as the Center for Device Regulation, Radiation Health, and Research (CDRRHR) with the jurisdiction to regulate the manufacture, importation, exportation, distribution, sale, offer for sale, transfer, promotion, advertisement, sponsorship of, and/or, where appropriate, the use and testing of devices. The CDRRHR thru the Radiation Regulation Division has been given the powers and functions over the use of radiation devices...

 

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