Licensing

Note:These documents are in PDF and Word format.

Electronic Products

Licensed electromedical products

• Licensed electromedical devices - by licence no - Part 1 and Part 2 [Last updated 5 March 2008]
• Licensed electromedical devices - by licence holder & device - Part 1 and Part 2 [Last updated 5 March 2008]
• Licensed electromedical devices - by DOH code, dealer & device - Part 1 and Part 2 [Last updated 5 March 2008]

Acceptance Tests

• Recording and Image Processing – Test Procedures
• Radiography - Test Procedures
• Computed Tomography- Test Procedures
• Summary Computed Tomography Acceptance Standard and Results - revised 09-2006
• Radiography acceptance standards - revised 07-2006
• Summary Radiography Acceptance Results - revised 07-2006
• Mammography acceptance standards - revised 07-2006
• Summary Mammography Acceptance Results - revised 07-2006

Import or Manufacture

• 41BM-1(IMP) - Application for a licence to import or manufacture a listed electromedical product [MS Word]
• 41BN-1 - Application for licence to import or manufacture a listed non-medical device [MS Word]
• 41BM-1B - Additional Requirements - Electronic application for a licence to import or manufacture a listed electromedical product
• Policy - Requirements with regard to the application for a licence to either import, locally manufacture or refurbish any listed electromedical device (Revised Policy Document)

Licence Conditions

• Computed Tomography Conditions 07-2006
• Mammography Conditions - revised 07-2006
• Radiography Conditions - revised 07-2006
• Recording and Image Processing Conditions 07-2006
• Summary Computed Tomography Results 07-2006
• Summary Mammography Results - revised 07-2006
• Summary Radiography Results - revised 07-2006
• Summary Recording and Image Processing Results - 07-2006

Radiation Workers

• RC008 - Registration of radiation worker
• RC009 - Medical report on radiation worker
• RC010 - Notification of radiation occurrence
• RC013-1 - Application to register as an Industrial Radiographer - X-Ray Radiography
• Radiation Protection Services (SABS)
• Radiation Protection Services (NTP)

Mammography QA Forms

• Condition 1A
• Condition 1B
• Condition 2
• Condition 3
• Condition 4
• Condition 5
• Condition 6
• Condition 7
• Condition 8
• Condition 9
• Condition 10, 11, 12
• Condition 13
• Condition 14
• Condition 15
• Condition 16

Processing QA Forms

• Condition 1.1
• Condition 1.2a
• Condition 1.2b
• Condition 1.3 and 1.4
• Condition 4

Report Forms

• Mammography - Submission (end of January) of results of Annual Tests Conditions 8-17
• RC011-1(rev 1) - Details of Transaction as per condition 03 or 04 of your licence to either Import or Manufacture (MS Word)
• RC011-1(DIAGNOSTIC) - Details of Transaction as per Condition 03 of your Licence to Import or Manufacture (MS Word)
• RC011-1 (DENT) - Application for a licence to Use and Details of Transaction as per Condition 03 of your Licence to Import or Manufacture (MS Word)

Use

• RC001 (10/2008) Belville - Application for a licence to use an X-ray device
• RC001 (10/2008) Durban - Application for a licence to use an X-ray device
• RC001 (10/2008) Pretoria - Application for a licence to use an X-ray device
• RC002 (10/2008) Bellville - Change of Responsible Person, Disposal of a licensed Electronic Product and/new/modified Premises
• RC002 (10/2008) Pretoria - Change of Responsible Person, Disposal of a licensed Electronic Product and/new/modified Premises
• RC002 (10/2008) Durban - Change of Responsible Person, Disposal of a licensed Electronic Product and/new/modified Premises
• RC003-1 - Application for a licence to use a therapeutic device (ionising radiation)
• RC003-1(2006) - Application for a licence to use a therapeutic device or particle accelerator
• RC003-2(2006) - Change of Responsible person or Medical Physicist
• RC003-3(2006) - Modification or disposal therapeutic device
• RC004-1 - Application for premises licence to maintain or install X-ray devices
• SBLM-1 - Application for licence to use a medical laser
• SBLN-1 - Application for licence to use a non-medical laser
• SBMR-1 - Application for a licence to use, operate, apply, install or keep installed a Magnetic Resonance Imaging (MRI) device/system

Radionuclides

• RC008-1 - Registration of radiation worker
• RC009-1 - Medical report on radiation worker
• RC010-1 - Notification of radiation occurrence
• RN001 - Monthly return of sealed radionuclides
• RN002 - Monthly return of unsealed radionuclides
• RN186D - Annual report on the use of radioactive nuclides for in vitro diagnostic purposes
• RN186T - Annual report on the use of radioactive nuclides for therapeutic purposes
• RN523 - Application for disposal (discarding) of liquid radioactive waste
• RN524 - Application for disposal (discarding) of solid radioactive waste
• RN525 - Application for disposal (discarding) of sealed radioactive material
• RN526 - Application to dispose (sell), acquire, convey and cause to convey radioactive nuclides
• RN606 - Record of previous occupational exposure to ionising radiation
• RN607 - Medical report
• RN608E - Particulars of sealed radioactive sources
• RN758 - Annual report on the use of unsealed radioactive nuclides
• RN778 - Application to register as an industrial radiographer
• RN780 - Log for sealed gamma radiography sources
• RN781 - Application to import, dispose (sell), possess, convey and cause to convey radioactive nuclides
• RN782 - Application to export, convey and cause to convey radioactive nuclides
• RN785 - Application for the transfer of sealed radioactive nuclides by a radiation protection officer to his successor
• RN787 - Application to acquire, possess, use, convey and cause to convey radioactive nuclides
• RN788 - Application for the temporary use, possession and transport of equipment containing radionuclides
• RN789 - Application to only convey radioactive nuclides
• RN855 - Application to do maintenance work on apparatus containing radioactive material (sealed sources)
• RN900 - Report following the loss, theft, or damage to a radionuclide