Frequently Asked Questions
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Frequently Asked Questions
Below are all the questions that are frequently asked. The below information should help you with what you are trying to achieve.
Q: I Purchased an X-ray machine from China how do I get it registered here?
A: It is ilegal to purchase and use an X-ray machine from any country unless you are registered importer and the x-ray machine has been aproved for use by the South African Health Products Regulatory Authority Radiation Control.
Q:What happens if you cannot find the x-ray machine on the South African Health Products Regulatory Authority?
A: Any old licencing documentation that you may have may be helpful. It is possible that at some stage the unit was labelled as disposed of by the previous owner and then later on he decided to sell the machine. In this case it may be possible for the Department of Health to find this unit in their archives. (there are no guarantees of this) You will then need to re register the unit in your name by filling in an RC001 form. However the best way to deal with this will be to send an email to to Natalie.Britz@health.gov.za giving as much information as you can..
Q:What happens if the machines are not registered with radiation Control?
A: It is the responsibility of the seller to make sure the units are registered or you could end up paying for a machine that you cannot use.
Q: The medical aid has asked me for proof of inspections done on my x-ray machine what do I do?
A: You can ask Gendentsa to send a letter of confirmation stating the machine has been inspected if it has. If it has not been inspected or it is overdue you should have it inspected as soon as possible to avoid any issues with the medcial aids.
Q: It seems ridiculous to have Digital sensor have an acceptance tes done on it. it doesn't emit radiation why must this be done.
A:It is true that a digital sensor does not emit x-ray however it forms part of “the image chain” Even a new sensor can have a fault on it and may not be noticed by the user this can affect the ability of the practitioner to diagnose accurately. X-ray sensors deteriorate over time and a base line image is taken by the inspection Body and monitored over time for deterioration.
Q: I am desperate my x-ray machine has stopped working and I need to buy a new machine or sensor but my inspections are overdue whats the fastest way to get this resolved.
A: You need to act as fast as possible as it can take as long as 1 to 2 months to resolve this. Once we have quoted you please pay your 50% deposit and send back the forms we send you. as soon as possible. We cannot book an inspection without these 2 things. As a SANAS accredited facility we must have terms and conditions and account info signed. We are audited every year and they check for this.
Q: I have a pre-owned x-ray unit and have not transferred the unit into my name how do I go about this?
A: You will need to know who the unit was purchased from in order to get the machine into your name. If you do not remember who you purchased the machine from you can call Gendentsa and ask us to check the serial number for you on the South African Health Products Regulatory Authority database. If we are able to trace the previous owner, then you can ask the previous owner to fill in the RC002 Form and also see if they have any licencing documentation and send the form to Debbie.Coetzee@health.gov.za . You will then need to fill in the RC001 form to transfer into your name.
Q: I am buying a practice from another Dr what do I need to do?
A: MOST IMPORTANTLY check the machines are registered with Radiation Control first you can call Gendentsa and we will be able to check for you, then check with the Dr if he has had the x-ray units inspected. If the unit is overdue for inspection it will need to be inspected first before transfer of ownership can take place. If the machines inspections are up to date and the machine is not being physically moved, then the seller must fill in the RC002 form and the buyer must fill in the RC001 form and these forms must be sent to Debbie.Coetzee@health.gov.za . If you are moving the x-ray machine It will need to be inspected by a SANAS accredited inspection Body aproved for inspection of Dental Equipment once the machine has been moved and both the RC002 and RC001 formas must filled in and sent to Debbie.Coetzee@health.gov.za .
Q: I bought an X-ray machine from a Dr who is deceased and, or has left the country and I am unable to contact them and I want to get the unit registered in My name?
A: You will need to get an Affidavit stating this and then send that together with your RC001 form to Radiation Control. Natalie.Britz@health.gov.za . If the machine is still in the previous owners name transfer should not be a problem.
Q: Why must I have my x=ray machines inspected we never had to do this before?
A: Inspections of x-ray units are an international requirement and a legally enforceable requirement here in South Africa. and fall under the Hazardus substance act. Failure to comply may result in your licence being revoked. Apart from the legal requirements. X-ray units, reporting monitors and sensors deteriorate over time, this is a gradual process and is not noticed by the user.
Q: My x-ray units are overdue for inspection and the South African Health Products Regulatory Authority will not issue me a license for a new device what must I do?
A: Contact Gendentsa here and we can check what machines are due for inspection, check if there are any units registered on your name that you no longer have, send you the correct forms to have those removed for you. Once we have established exactly what you are using we will send you a quotation.
Statement Of Impartiality
Everyone Statement Of Impartiality
IAEA South Africa
International Atomic Energy Agency
Hazardous Substance Act
Hazardous Substance Act No. 15, 1973