Guideline for QC in Dental Diagnostic X-Ray Imaging Systems

The South African Health Products Authority (SAHPRA) is the regulatory authority of South Africa responsible for the regulation of health products intended for human and animal use; amongst others, radiation emitting devices and radioactive nuclides.

The legislative mandates of SAHPRA are derived from the Constitution; the National Health Act, 2003 (Act No. 61 of 2003); the Medicines and Related Substances Act, 1965 (Act No. 101 of 1965), as amended (hereinafter referred to as "the Medicines Act"); and other relevant legislation, regulations and policies.

Further, SAHPRA's mandate has expanded to include the regulation and control of radiation emitting devices and radioactive nuclides under the Medicines Act and the Hazardous Substances Act, 1973 (Act No. 15 of 1973). The Hazardous Substances Act does not allow any person to use radiation equipment unless he/she holds a licence under the Act for that purpose.

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