Philippines: The FDA alters requirements for radiation licensing during COVID-19

The FDA has issued a circular No.2020-035 on 19 November 2020 regarding the Interim guidelines for the conduct of Licensing Inspection for Radiation Facilities. The following facilities are required to apply for an initial application for the authorization on the use of radiation devices during all types of community quarantine:

1. Diagnostic X-rays Facilities

2. Therapeutic X-ray Facilities utilizing Medical Linear Accelerators

3. Dental X-ray Facilities

4. Industrial and Anti-Crime X-ray Facilities

5. Education and Research X-ray Facilities

6. Veterinary X-ray Facilities

7. Transportable X-ray Facilities

8. Magnetic Resonance Imaging Facilities

The FDA shall resume the conduct of pre-licensing inspections for Therapeutic X-ray Facilities utilizing Medical Linear Accelerators only. It will be done through on-line or virtual inspection with the general procedures. An interim radiation facility authorization process shall be done for all other types of radiation facilities according to a risk-based approach. After the end of quarantine, it will be verified through post licensing inspection.

Source: FDA-Circular-2020-035 Contact us at info@arqon.com for more info