Wikiprocedure

South Africa - Obtain Licence to Use Therapeutic Device (Ionising Radiation)

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ProcedureEdit

Apply In-Person:

  1. To apply for obtaining license to use Therapeutic Device (Ionising Radiation) in person, the applicant has to visit the office of South African Health Products Regulatory Authority.
  2. For contact details, refer “Radiation Control” in the following link: Link
  3. Visit the office and obtain an Application for a licence to use a therapeutic device or particle accelerator (RC003-12006 form) from the concerned department. Or click to download: Link
  4. Enquire the officials at the office about the documents to be attached with the completed application form. Complete the application form as required with relevant information and details.
  5. After completing the application form with respect to the need, attach the required documents with the completed form.
  6. Then, submit it to the respective authority at the office of South African Health Products Regulatory Authority.
  7. Also pay the prompted fees as required. After that, your application form and documents attached will be forwarded further for various processes of verification and validation.
  8. Once all the processes are done and documents are found in order, your application will be approved and license will be issued with prior notification.


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Required DocumentsEdit

  • Completed application form
  • Detailed plan or sketch of the device room
  • HPCSA Registration document
  • Document for Qualification
  • Identity document/Passport
  • Device registration document
  • Purchase bill or invoice
  • Proof of payment
  • Any supporting document (as instructed)


Office Locations & ContactsEdit

SA Health Products Regulatory Authority (SAHPRA) Head Office
Physical Adsress:Building A
Loftus Park
402 Kirkness Street
Arcadia
Pretoria
0001
South Africa
Postal Adsress:PPrivate Bag X828
Pretoria
0001
South Africa
Tel: 012 395 8000
Email: [email protected]
Website link

Department of Health South Africa Head Office
Physical Adsress:Dr AB Xuma Building, 1112 Voortrekker Rd,
Pretoria Townlands 351-JR,
PRETORIA, 0187
South Africa
Postal Adsress:Private Bag X828,
PRETORIA,
0001
South Africa
Tel: 012 395 8000
Email: [email protected]
Website link

EligibilityEdit

  • Any legal entity, like a South African registered company, university, governmental department or hospital, is eligible to apply.
  • Any partnership or trust of any of the above mentioned legal entities can also apply.


FeesEdit

You can obtain any details regarding the fees from the office that you visit to apply.


ValidityEdit

Explain the time until which the certificate/document is valid.
e.g. Birth Certificate Valid Forever


Documents to UseEdit

Application for a licence to use a therapeutic device or particle accelerator (RC003-12006 form): Link


Sample DocumentsEdit

Please attach sample completed documents that would help other people.


Processing TimeEdit

Please explain processing time taken in obtaining the document/certificate.


Related VideosEdit

Videos explaining the procedure or to fill the applications.
Attach videos using the following tag <&video type='website'>video ID|width|height<&/video&> from external websites.
Please remove the '&' inside the tags during implementation.
Website = allocine, blip, dailymotion, facebook, gametrailers, googlevideo, html5, metacafe, myspace, revver,
sevenload, viddler, vimeo, youku, youtube
width = 560, height = 340, Video ID = Can be obtained from the URL of webpage where the video is displayed.
e.gIn the following url 'http://www.youtube.com/watch?v=Y0US7oR_t3M' Video ID is 'Y0US7oR_t3M'.


InstructionsEdit

Applicants are advised to refer the following document to get to know some of the conditions regarding the User License: Link


Required InformationEdit

  • Applicant’s particulars/establishment section
  • Contact number, email address and fax number
  • Postal address
  • Identity document numbers
  • Particulars of the responsible person
  • Particulars of Appointed Medical Physicist
  • HPCSA registration numbers
  • Qualifications and Designation details
  • Particulars of Appointed Acting Medical Physicist
  • Identification particulars of the product
  • Factors of operation
  • Generic description and activities contemplated
  • Particulars of the device premises
  • Details of the supplier
  • Details of the installer
  • Details of the maintainer


Need for the DocumentEdit

Any legal entity such as a South African registered company, university, governmental department or hospital, which wants to possess and operate a Therapeutic device producing ionising radiation must obtain a license from the South African Health Products Regulatory Authority by applying in a prescribed format.


Information which might helpEdit

Enter other informations which might help.


Other uses of the Document/CertificateEdit

Please explain what are other uses of obtaining this document/certificate.
e.g. Birth Certificate can be used as proof of identity.


External LinksEdit

Link


OthersEdit

More information which might help people.


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