We are often asked whether a particular machine is the same as ours or whether machines need to be licensed in South Africa. As a registered medical device provider, it would be unethical for us to comment on other legal devices. With regards to unlicensed devices, we can offer you the following information on licensing a medical device in South Africa.
Legally, all devices that purport to treat, diagnose, or cure any disease are subject to the Medical Devices Regulatory Act of 1998. The Act defines a medical device as:
“any instrument, appliance, material, machine, apparatus. implant or diagnostic reagent or any other article, whether used alone or in combination, including software necessary for its proper application used for or purporting to be suitable for use or manufactured or sold for use in or on a human or animal body-
(i) in the diagnosis, prevention, monitoring, treatment or alleviation of disease; or
(ii) in diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap;”
In other words, if a machine claims to help, reduce or treat or cure any ailment or condition, then it is subject to this Act.
Every medical device must be submitted to the Authorities for registration:
(1) An application for the registration of a medicine, complementary medicine, veterinary medicine or device must be submitted to the Authority.
This means that even devices that are registered elsewhere like America or Europe, still have to be licensed in South Africa and they must have a South African License.
The Act states that:
(1) Subject to this section, no person may sell, have in his or her possession or manufacture any orthodox medicine, complementary medicine, veterinary medicine, device, or Scheduled substance, except in accordance with the prescribed conditions.
(6) No manufacturer, wholesaler, or distributor referred to in subsection (l)(b) may manufacture, act as a wholesaler of or distribute, as the case may be, any orthodox medicine, complementary medicine, veterinary medicine, or medical device unless that person is a holder of a license contemplated in the said subsection.
In other words, you may not manufacture, sell or distribute unlicensed devices or have an unlicensed device in your possession. If you are found to be selling, marketing, manufacturing, using or distributing an unlicensed device then the act says:
Any person who- (k) contravenes section 31 or contravenes or fails to comply with any condition imposed thereunder; is guilty of an offence
(1) Any person who is convicted of an offence referred to in section 41 is liable to a fine, or to imprisonment for a period not exceeding 10 years.
(2) The court convicting any person of an offence under this Act may, upon the application of the prosecutor, declare any medicine, complementary medicine, veterinary medicine, medical device or Scheduled substance in respect of which the offence has been committed to be forfeited to the State.
(3) Any medicine, complementary medicine, veterinary medicine, medical device or Scheduled substance forfeited under this Act must be destroyed or otherwise dealt with as the Authority may direct.
In other words, if an unlicensed or illegal device is found in your possession, or if you manufacture, distribute or use an unlicensed device then you could be found guilty of an offence and can be fined or sent to prison for up to 10 years or both. Your device can be confiscated and destroyed by the State.
Unscrupulous device manufacturers claim that their machines do not need to be licensed for various reasons. They claim they are manufactured individually and therefore do not need a license. This is not true – based on the Act. They claim their machines meet certain international standards and therefore do not need to be licensed. This is not true. Even devices manufactured in terms of the ISO or Ce regulations need a South African license. They claim their machines are licensed with a CE mark or FDA approved and therefore do not need a South African license. CE marks and FDA marks are important but those machines still need a South African license.
The truth is that a license for a medical device can be compared to a license to drive a car. You can drive a car without a license. There are thousands of people who drive cars in South Africa on a daily basis who do not have a valid drivers license. For the most part they are not caught. But when something goes wrong, when they are in an accident or someone gets hurt, then they are guilty of an offence which will cost them dearly. Yes, you can buy unlicensed devices, you can choose to promote unlicensed devices and you can even use them to treat people, albeit illegally, but when a person is harmed by one of these devices, then you could be guilty of an offence and it could be as serious as manslaughter depending on the harm that is done.
If you want to know whether a device is legal, ask for the SOUTH AFRICAN device registration number and check with the Department of Radiation in South Africa to make sure your device is registered as a medical device in South Africa. Don't accept excuses from manufacturers that their device does not need a license. The license is designed to keep you safe and there should be no reason why a device does not need to be licensed to ensure it is safe for the public.
Our South African license number is: 402/154616. Our license appears every machine - as part of the legal requirement. If you device does not have a license number on the device, it is probably not licensed and is therefore probably illegal.