Philippines: Draft Guidelines for Rules and Regulations for Establishment and Operation of Medical Magnetic Resonance Imaging (MRI) Facilities
The Food and Drug Administration (FDA) Philippines has issued draft guidelines to specify the requirements on the use and operation of facilities utilizing Magnetic Resonance Imaging (MRI).
In the draft guidelines, all MRI facilities would be required to secure an authorization from FDA through the current rules and regulations on the licensing and registration of radiation facilities.
The initial license to operate shall be valid for five (5) years and shall be renewed based on the criteria and guidelines established by the CDRRHR Radiation Facilities’ rules and regulations.
This draft guideline shall cover and apply to all manufacturers, suppliers, testing service providers, firm, corporation, government or private establishments or entity that uses MRI devices, operating and/or maintaining MRI facilities, including health professionals or individuals involved in the practice.
All existing MRI facilities shall be given 3 years from effectivity date to comply with the quality assurance program requirements, MRI safety program, and safety assessment plan/program indicated in the draft guideline.
For more in depth information about this guideline, please refer to the link.
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