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 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

To expedite your application:

• Please submit one application per email
• List the name of the applicant and model in the subject field of the email,
• Please ensure that all required documentation as listed on the GLF-RDN-XR-24C (New) 41BM IMP(OLD) or GLF-RDN-XR-24F_v1 (New) 41BN IMP (Old) application forms have been submitted.
• Complete your application in full as incomplete applications will be returned,
• Kindly refrain from pre-dating your application form,

1. For new medical x-ray device, the supplier/dealer and the user licence holder/applicant must complete the RCDEALER form in full.
2. For new dental x-ray device, the supplier/dealer and the user licence holder/applicant must complete the RCDENT form in full.
3. 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.
4. For the new Therapeutic device, the supplier/dealer and the user licence holder/applicant must complete the RC003-1 form in full.
5. 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 15 working days.
2. Results do not reflect immediately upon submission and must be configured for upload to the database.
3. 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/

For the licencing of Medical device establishments and the registration of Medical devices (In vitro diagnostics (IVDs) and non-IVD Medical devices), does this apply for radiology equipment as well (x-ray, CT, MRI)?  Or is our licence with Radiation Control sufficient?

1.  Radiology equipment is classified as Medical Devices too.
2. Medical Devices in South Africa are governed by two sets of legislation, Act 101 of 1965 as amended and Act 15 of 1973.  For enquiries regarding compliance to Act 101 of 1965, please contact our Medical Device Unit mdqueries@sahpra.org.za
3. For enquiries regarding compliance to the Act 15 of 1973, please contact our Radiation Control X-ray section at import.xrays@sahpra.org.za
4.  For enquiries regarding compliance to the Act 15 of 1973 in terms equipment emitting non-ionizing radiation (MRI, Laser, Ultrasound etc), please contact our Radiation Control NIRMED section at  nirmed.enquiry@sahpra.org.za

Licences in terms of either Medicines and Related Substances Act (Act No 101 of 1965 as amended) or Hazardous Substances Act (Act No 15 of 1973) are not issued simultaneously; does a successful licence application outcome for the one set of legislation mean automatic approval in terms of the other?

1.  No.
2. SAHPRA is tasked with regulating (monitoring, evaluating, investigating, inspecting and registering) all health products. SAHPRA’s mandate is outlined in the Medicines and Related Substances Act (Act No 101 of 1965 as amended) as well as the Hazardous Substances Act (Act No 15 of 1973).

What is the difference between Veterinary and Human Medical Imaging?

1. Veterinarians are not trained to read human x-rays and vice versa.
2. Human and animal bone structures have different densities.  Animal bones have a greater density relative to size; they are less porous and are thicker in cross section than the bones of humans.
3. The exposure factors used on the machines and the approach in both diagnosis and treatment differ greatly for pets than they do patients.