FAQs – X-RAYS

1. Ionising radiation devices (X-RAY) can be used for medical purposes or non-Medical Purposes. The form for medical purposes is 41BM-1(IMP) and for non-medical purpose 41BN-1(IMP).
2. The above forms can be obtained from the website https://www.sahpra.org.za/radiation-control- application-and-report-forms/ or it may be also requested from import.xrays@sahpra.org.za

1. For medical 41BM-1 IMP:
   • Annexure 1: Completed application form 41BM-1(IMP); and
   • Annexure 2: Colour brochure (including technical specifications); and
   • Annexure 3: Letter of appointment as authorised representative of the original manufacturer; and
   • Annexure 4: EC Certificate(s) issued by a Notified Body in terms of EC Directive 93/42/EEC or 90/385/EEC (whichever one is applicable); and
   • Annexure 5: EC Declaration of Conformity by the manufacturer in terms of EC 93/42/EEC or 90/385/EEC (whichever one is applicable).
2. For non-medical 41BN-1 IMP:

a.               A colour brochure containing the technical specifications for this model must accompany the completed application form

1. Application must be sent to xray@sahpra.org.za
2. The outcome of the application should be expected in less than 30 working days

1. For new medical x-ray device, the supplier/dealer and the user licence holder/applicant must

complete the RCDEALER form in full.

1. For new dental x-ray device, the supplier/dealer and the user licence holder/applicant must complete the RCDENT form in full.

• For used equipment, the new user must fill in full the RC001 form, and the previous owner must fill in full the RC002 form both forms should be submitted simultaneously.

1. For the new Therapeutic device, the supplier/dealer and the user licence holder/applicant must complete the RC003-1 form in full.
2. For used Therapeutic device, the new user must fill in full the RC003-1 form, and the previous owner must fill in full the RC003-3 form both forms should be submitted simultaneously

The above forms can be obtained from the website https://www.sahpra.org.za/radiation-control-application- and-report-forms/

No a device remains the responsibility of the supplier/dealer in case of new equipment or previous owner in case of a used machine therefore delivery/transfer/installation must only happened once a MAY INSTALL is issued by the regulator.

1. As per regulation no 1332 section III.2 Licence remain in effect until request for cancellation or temporary or permanent transfer that is approved by the regulatory authority.
2. Therefore, licence do not expire

1. No licences to use medical x-rays are issued to general practitioners
2. Licences are only issued to medical institutions, radiologist, and private radiographers.

1. The Electronic submission blank sheet is distributed monthly and upon receipt of results the turnaround time is 21 working days.
2. Enquiries may be forwarded to es.xrays@sahpra.org.za

1. Responsible persons have the obligation to inform the regulator when they are no longer designated to the holder and the holder must appoint a new responsible person using the RC005 form. Forms available as per link above.

1. The guidelines and code of practices are published on the website and any new updated guidelines will be communicated with relevant stakeholders https://www.sahpra.org.za/radiation-control- guidelines-and-codes-of-practice/
2. The acts and regulations mandating radiation control are available in the following link https://www.sahpra.org.za/radiation-control-acts-and-regulations/